Viewing Study NCT03811002

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Ignite Creation Date: 2025-12-25 @ 4:04 AM
Ignite Modification Date: 2026-03-06 @ 4:51 PM
Study NCT ID: NCT03811002
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-12-03
First Post: 2019-01-18
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C044245', 'term': '1,2-diaminocyclohexaneplatinum II citrate'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'seiferheldw@nrgoncology.org', 'phone': '215-574-3208', 'title': 'Wendy Seiferheld', 'organization': 'NRG Oncology'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The second planned interim efficacy analysis met the early stopping rule for futility. Per the protocol, the second planned interim analysis occurred after 222 deaths had been reported across both arms combined. The final analysis would have otherwise taken place after 315 deaths.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline to the date of last known follow-up. Median follow-up was 23.8 months.', 'description': 'All-cause mortality was assessed in the intent-to-treat population. Adverse events were assessed in adverse event population.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.', 'otherNumAtRisk': 257, 'deathsNumAtRisk': 270, 'otherNumAffected': 253, 'seriousNumAtRisk': 257, 'deathsNumAffected': 120, 'seriousNumAffected': 106}, {'id': 'EG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.', 'otherNumAtRisk': 264, 'deathsNumAtRisk': 274, 'otherNumAffected': 263, 'seriousNumAtRisk': 264, 'deathsNumAffected': 132, 'seriousNumAffected': 159}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 210}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 220}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 41}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 26}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 36}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 49}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 41}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 123}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 101}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 86}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Esophageal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 158}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gastrointestinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 139}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 165}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 72}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 182}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 200}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Infections and infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dermatitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 63}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 44}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 59}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 42}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 59}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Investigations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 163}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 172}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 220}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 226}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 189}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 212}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 86}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 209}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 222}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 127}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 58}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 79}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 79}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 58}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 95}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 71}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 102}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Muscle cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain in 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Musculoskeletal and connective tissue disorder - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nervous system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Radiculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Transient ischemic attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Renal and urinary disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Renal calculi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bronchopulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pleural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Arterial thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Peripheral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000', 'lowerLimit': '28.1', 'upperLimit': '42.5'}, {'value': '31.1', 'groupId': 'OG001', 'lowerLimit': '28.5', 'upperLimit': '44.7'}]}]}], 'analyses': [{'pValue': '0.5819', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.34', 'estimateComment': 'Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.', 'groupDescription': 'Assuming exponentially distributed survival times, 480 eligible patients accrued uniformly over 48 months months) with 26 months additional follow-up after the last accrued patient would provide at least 85% power to detect a hazard ratio of 0.71 (median survival times of 38 months \\[Arm I\\] vs. 27 months \\[Arm II\\]) at a one-sided significance level of 0.025, after adjusting for type 1 error using group sequential methods for two interim analyses.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). 1-sided significance level 0.025.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months.', 'description': 'Survival rates and median survival time are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '13.2'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '15.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.21', 'estimateComment': 'Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to progression or death due to any cause, whichever occurs first, or last tumor assessment if alive. MMedian follow-up at the time of analysis was 23.8 months.', 'description': 'PFS failure event is defined as progressive disease (PD) determined by investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause. PD is defined as at least a 20% increase in the sum of longest diameters of target lesions, and an absolute increase of at least 5 mm. The appearance of any new lesions is also considered progression. PFS rates and median PFS time are estimated using the Kaplan-Meier method, censoring participants alive without progression at the date of their last evaluable radiographic tumor assessment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Number of Participants by Highest Grade Adverse Event Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}], 'classes': [{'title': 'Overall', 'categories': [{'title': 'None reported', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Grade 3', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Grade 4', 'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}, {'title': 'Grade 5', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Immune-mediated', 'categories': [{'title': 'None reported', 'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Grade 3', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Grade 4', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Grade 5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Non-Immune-Mediated', 'categories': [{'title': 'None reported', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Grade 3', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'title': 'Grade 4', 'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}, {'title': 'Grade 5', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to last follow-up. Median follow-up at the time of analysis was 23.8 months.', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse event population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Objective Response (Objective Response Rate (ORR))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'groupId': 'OG000', 'lowerLimit': '53.5', 'upperLimit': '65.5'}, {'value': '60.2', 'groupId': 'OG001', 'lowerLimit': '54.2', 'upperLimit': '66.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to last radiographic tumor assessment. Median follow-up at the time of analysis was 23.8 months.', 'description': 'Objective response rate (ORR) is defined as the proportion of subjects whose best overall response (BOR) is a confirmed complete or partial response as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 on two consecutive occasions ≥4 weeks apart.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Local Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}], 'classes': [{'title': '1 year', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '14.4'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '12.0'}]}]}, {'title': '2 years', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '19.3'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '17.5'}]}]}, {'title': '3 years', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '19.3'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '17.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.41', 'estimateComment': 'Cause-specific hazard ratio stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to local progression, other progression, or death, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months. 1-, 2-, and 3-year rates are reported.', 'description': 'Local progression is defined as intrathoracic tumor progression (failure in the lobe of the primary tumor or mediastinal lymph nodes) by RECIST 1.1 criteria determined by the investigator. Local progression rates are estimated by the cumulative incidence method, treating non-local progression (i.e., distant metastasis or failure in a different lung) and death without local progression as competing risks, and otherwise censoring participants alive at last tumor assessment. Treatment effect comparisons will utilize a cause-specific hazard function in which competing risks are censored.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Distant Metastases-free Survival (DMFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '18.2'}, {'value': '16.8', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '21.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.20', 'estimateComment': 'Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm I.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to DMFS event or local progression, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months.', 'description': 'DMFS failure event is defined as first date of documented distant metastases (or failures in a different lung lobe) or death due to any cause, whichever occurs first. Participants with local progression prior to such an event are censored on the date of local progression. Participants with no post-baseline tumor assessment and alive at last follow-up are censored on the date of randomization. Participants alive without distant metastasis, failures in a different lung lobe, or local progression are censored on the date of their last evaluable radiographic tumor assessment. DMFS rates and median DMFS time are estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Deterioration in Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization)', 'description': 'FACT-TOI is a measure of 21 items that sums the functional well-being (FWB), physical well-being (PWB), and the lung cancer subscale (LCS) of the Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life (QOL) instrument. The FACT-TOI total score ranges from 0 to 84 with higher scores indicating better quality of life and functioning. Clinically meaningful decline is defined as a decrease from baseline of at least 5 points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat participants with FACT-TOI at baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization).'}, {'type': 'SECONDARY', 'title': 'Quality-adjusted Survival Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '17.7'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '16.6', 'upperLimit': '18.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to death, last follow-up or two years, whichever occurs first.', 'description': 'Quality-adjusted survival is calculated as the sum of weighted time intervals. Weight is the EuroQol 5-dimensional 5-level (EQ-5d-5L) index score, which measures health-related quality of life and ranges from 0 (death) to 1 (full health).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants with baseline EQ-5D-5L index score and at least one follow-up EQ-5D-5L index score.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the 7 Item Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'OG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization)', 'description': 'The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat participants with score at baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization).'}, {'type': 'SECONDARY', 'title': 'Molecular Subtyping', 'timeFrame': 'Up to 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2029-02'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient-reported Symptomatic Toxicities', 'timeFrame': 'Up to 15 months after completion of chemoradiation therapy', 'description': 'Will be measured by Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE). For each symptom and each domain (i.e., frequency, severity, and interference), counts and frequencies will be summarized for the worst score experienced by the patient by treatment arm.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Concordance Between Tumor and Circulating Cell Free Deoxyribonucleic Acid (cfDNA) Molecular Subtypes', 'timeFrame': 'Up to 5 years', 'description': "The concordance between molecular subtypes obtained via ribonucleic acid sequencing (RNAseq) on tumor tissue and methylation analysis on cfDNA will be assessed among patients who have both evaluable RNAseq and methylation results, where Cohen's Kappa and corresponding 95% confidence interval will be reported. In addition, the sensitivity and specificity of dichotomized cfDNA molecular subtypes (considering RNAseq as reference standard), along with the associated 95% confidence intervals, will be reported. Spearman rank correlation and associated 95% confidence intervals based on bootstrap between RNAseq and methylation will be reported.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Effect by Sex', 'timeFrame': 'Up to 5 years', 'description': 'Estimates of the primary outcome treatment effect and the corresponding 95% confidence intervals by sex will be provided.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Effect by Race', 'timeFrame': 'Up to 5 years', 'description': 'Estimates of the primary outcome treatment effect and the corresponding 95% CIs by race will be provided.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment Effect by Ethnicity', 'timeFrame': 'Up to 5 years', 'description': 'Estimates of the primary outcome treatment effect and the corresponding 95% CIs by ethnicity will be provided.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or intensity-modulated radiation therapy (IMRT) twice daily (BID) for approximately 3 weeks or once daily (QD) for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'FG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'Adverse Event Population', 'comment': '"As treated" randomized participants, counted on the arm matching the treatment they received.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '264'}]}, {'type': 'Intent-to-treat (ITT)', 'comment': 'Randomized participants counted on the treatment arm to which they were randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'COMPLETED', 'comment': 'Participants contributing data to results are considered to have completed the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Chemotherapy, Radiation Therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'BG001', 'title': 'Arm II (Chemotherapy, Radiation Therapy, Atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '85'}, {'value': '66', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '84'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': '≤ 49', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '50 - 59', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': '60 - 69', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}, {'title': '≥ 70', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, \\<50% in bed during the day; 3 = Symptomatic, \\>50% in bed, but not bedbound; 4 = Bedbound; 5 = Death', 'unitOfMeasure': 'Participants'}, {'title': 'Platinum regimen (as randomized)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Carboplatin', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}, {'title': 'Cisplatin', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'RT Schedule (as randomized)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Twice a day (3 weeks)', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}, {'title': 'Daily (6.5 weeks)', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'T-Stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'T0 (No primary tumor)', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'T1 (Tumor ≤3 cm in size)', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'T2 (Tumor >3 cm but ≤5 cm or involves main bronchus, visceral pleura, or causes lung collapse.)', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'T3 (Tumor >5 cm but ≤7 cm or multiple tumors in the same lobe.)', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'T4 (Tumor >7 cm or invades nearby structures or has multiple tumors in different lobes.)', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'TX (Primary tumor cannot be assessed)', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'N-Stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'N0: No regional lymph node involvement.', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'N1: Cancer in nearby lymph nodes.', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'N2: Cancer in lymph nodes in the center of the chest (mediastinum).', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}, {'title': 'N3: Cancer in lymph nodes on the opposite side of the chest or above the collarbone.', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'NX: Cannot be assessed', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'American Joint Committee on Cancer (AJCC) Stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'IA: T1, N0, M0', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'IB: T2b, N0, M0', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'IIA: T2b, N0, M0', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'IIB: T1a-c or T2a-b, N1, M0; or T3, N0, M0.', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'IIIA: T1a-c or T2a-b, N2, M0; or T3, N1, M0; or T4, N0-1, M0.', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}, {'title': 'IIIB: T1a-c or T2a-b, N3, M0; or T3, N2, M0; or T4, N2, M0.', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'IIIC: T3 or T4, N3, M0', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The AJCC staging system is a standardized method for describing the extent and severity of cancer using the TMN System: T (Tumor): Size and extent of the primary tumor; N (Nodes): Involvement of regional lymph nodes; M (Metastasis): Presence of distant metastasis. Higher numbers indicate more advanced disease, zero indicates none. Categories may be further subdivided by letters, with higher letters indicating more advanced disease. The stage groupings are based on the TNM components, grouping cancers into stages (0-IV), with higher numbers indicating more advanced disease.', 'unitOfMeasure': 'Participants'}, {'title': 'Primary tumor location', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Right Upper Lobe', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}, {'title': 'Left Upper Lobe', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Right Lower Lobe', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Left Lower Lobe', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Mediastinum', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Right Middle Lobe', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Multiple Sites', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Lingula', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Carina', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Main Bronchus, Left', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Main Bronchus, Right', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Undetectable Primary', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Forced Expiratory Volume in 1 second (FEV1)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '516', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.96', 'groupId': 'BG000', 'lowerLimit': '0.42', 'upperLimit': '6.08'}, {'value': '1.99', 'groupId': 'BG001', 'lowerLimit': '0.53', 'upperLimit': '3.94'}, {'value': '1.98', 'groupId': 'BG002', 'lowerLimit': '0.42', 'upperLimit': '6.08'}]}]}], 'paramType': 'MEDIAN', 'description': 'Forced expiratory volume (FEV1) is the amount of air one can forcefully exhale in one second after taking a deep breath, measured in liters per second.', 'unitOfMeasure': 'liters/second', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Participants with data'}, {'title': 'Percentage of Predicted FEV1', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '518', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '119'}, {'value': '74', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '123'}, {'value': '72', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '123'}]}]}], 'paramType': 'MEDIAN', 'description': 'Percent predicted FEV1 expresses FEV1 as a percentage of the average FEV1 of a healthy person of the same age, sex, height, and ethnicity.', 'unitOfMeasure': 'percentage of predicted value', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Participants with data'}, {'title': 'Percentage of Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'BG000', 'lowerLimit': '6.6', 'upperLimit': '138'}, {'value': '66', 'groupId': 'BG001', 'lowerLimit': '12.7', 'upperLimit': '138'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '6.6', 'upperLimit': '138'}]}]}], 'paramType': 'MEDIAN', 'description': "DLCO measures how well a person's lungs transfers oxygen moves from the lungs into the bloodstream. Percent predicted DLCO expresses DLCO as a percentage of the average DLCO of a healthy person of the same age, sex, height, and ethnicity.", 'unitOfMeasure': 'percentage of predicted value', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Participants with data'}, {'title': 'Cigarette use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Current', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'Former', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '366', 'groupId': 'BG002'}]}, {'title': 'Never', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-10', 'size': 5660375, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-28T15:12', 'hasProtocol': True}, {'date': '2024-07-10', 'size': 688456, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-28T15:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 544}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-02-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2019-01-18', 'resultsFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2019-01-18', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-05-28', 'studyFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient-reported Symptomatic Toxicities', 'timeFrame': 'Up to 15 months after completion of chemoradiation therapy', 'description': 'Will be measured by Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE). For each symptom and each domain (i.e., frequency, severity, and interference), counts and frequencies will be summarized for the worst score experienced by the patient by treatment arm.'}, {'measure': 'Concordance Between Tumor and Circulating Cell Free Deoxyribonucleic Acid (cfDNA) Molecular Subtypes', 'timeFrame': 'Up to 5 years', 'description': "The concordance between molecular subtypes obtained via ribonucleic acid sequencing (RNAseq) on tumor tissue and methylation analysis on cfDNA will be assessed among patients who have both evaluable RNAseq and methylation results, where Cohen's Kappa and corresponding 95% confidence interval will be reported. In addition, the sensitivity and specificity of dichotomized cfDNA molecular subtypes (considering RNAseq as reference standard), along with the associated 95% confidence intervals, will be reported. Spearman rank correlation and associated 95% confidence intervals based on bootstrap between RNAseq and methylation will be reported."}, {'measure': 'Treatment Effect by Sex', 'timeFrame': 'Up to 5 years', 'description': 'Estimates of the primary outcome treatment effect and the corresponding 95% confidence intervals by sex will be provided.'}, {'measure': 'Treatment Effect by Race', 'timeFrame': 'Up to 5 years', 'description': 'Estimates of the primary outcome treatment effect and the corresponding 95% CIs by race will be provided.'}, {'measure': 'Treatment Effect by Ethnicity', 'timeFrame': 'Up to 5 years', 'description': 'Estimates of the primary outcome treatment effect and the corresponding 95% CIs by ethnicity will be provided.'}], 'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months.', 'description': 'Survival rates and median survival time are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From randomization to progression or death due to any cause, whichever occurs first, or last tumor assessment if alive. MMedian follow-up at the time of analysis was 23.8 months.', 'description': 'PFS failure event is defined as progressive disease (PD) determined by investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause. PD is defined as at least a 20% increase in the sum of longest diameters of target lesions, and an absolute increase of at least 5 mm. The appearance of any new lesions is also considered progression. PFS rates and median PFS time are estimated using the Kaplan-Meier method, censoring participants alive without progression at the date of their last evaluable radiographic tumor assessment.'}, {'measure': 'Number of Participants by Highest Grade Adverse Event Reported', 'timeFrame': 'Randomization to last follow-up. Median follow-up at the time of analysis was 23.8 months.', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.'}, {'measure': 'Percentage of Participants With Confirmed Objective Response (Objective Response Rate (ORR))', 'timeFrame': 'Randomization to last radiographic tumor assessment. Median follow-up at the time of analysis was 23.8 months.', 'description': 'Objective response rate (ORR) is defined as the proportion of subjects whose best overall response (BOR) is a confirmed complete or partial response as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 on two consecutive occasions ≥4 weeks apart.'}, {'measure': 'Percentage of Participants With Local Progression', 'timeFrame': 'From randomization to local progression, other progression, or death, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months. 1-, 2-, and 3-year rates are reported.', 'description': 'Local progression is defined as intrathoracic tumor progression (failure in the lobe of the primary tumor or mediastinal lymph nodes) by RECIST 1.1 criteria determined by the investigator. Local progression rates are estimated by the cumulative incidence method, treating non-local progression (i.e., distant metastasis or failure in a different lung) and death without local progression as competing risks, and otherwise censoring participants alive at last tumor assessment. Treatment effect comparisons will utilize a cause-specific hazard function in which competing risks are censored.'}, {'measure': 'Distant Metastases-free Survival (DMFS)', 'timeFrame': 'Randomization to DMFS event or local progression, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months.', 'description': 'DMFS failure event is defined as first date of documented distant metastases (or failures in a different lung lobe) or death due to any cause, whichever occurs first. Participants with local progression prior to such an event are censored on the date of local progression. Participants with no post-baseline tumor assessment and alive at last follow-up are censored on the date of randomization. Participants alive without distant metastasis, failures in a different lung lobe, or local progression are censored on the date of their last evaluable radiographic tumor assessment. DMFS rates and median DMFS time are estimated using the Kaplan-Meier method.'}, {'measure': 'Percent of Participants With Deterioration in Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI)', 'timeFrame': 'Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization)', 'description': 'FACT-TOI is a measure of 21 items that sums the functional well-being (FWB), physical well-being (PWB), and the lung cancer subscale (LCS) of the Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life (QOL) instrument. The FACT-TOI total score ranges from 0 to 84 with higher scores indicating better quality of life and functioning. Clinically meaningful decline is defined as a decrease from baseline of at least 5 points.'}, {'measure': 'Quality-adjusted Survival Months', 'timeFrame': 'Baseline to death, last follow-up or two years, whichever occurs first.', 'description': 'Quality-adjusted survival is calculated as the sum of weighted time intervals. Weight is the EuroQol 5-dimensional 5-level (EQ-5d-5L) index score, which measures health-related quality of life and ranges from 0 (death) to 1 (full health).'}, {'measure': 'Change From Baseline in the 7 Item Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score', 'timeFrame': 'Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization)', 'description': 'The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue.'}, {'measure': 'Molecular Subtyping', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Limited Stage Lung Small Cell Carcinoma', 'Stage I Lung Cancer AJCC v8', 'Stage II Lung Cancer AJCC v8', 'Stage III Lung Cancer AJCC v8']}, 'referencesModule': {'references': [{'pmid': '36006678', 'type': 'DERIVED', 'citation': 'Higgins KA, Thomas A, Soto N, Paulus R, George TJ, Julian TB, Hartson Stine S, Markham MJ, Werner-Wasik M. Creating and Implementing a Principal Investigator Tool Kit for Enhancing Accrual to Late Phase Clinical Trials: Development and Usability Study. JMIR Cancer. 2022 Aug 25;8(3):e38514. doi: 10.2196/38514.'}]}, 'descriptionModule': {'briefSummary': "This phase III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To compare overall survival (OS) for patients with LS-SCLC treated with chemoradiation +/- atezolizumab.\n\nSECONDARY OBJECTIVES:\n\nI. To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab.\n\nII. To determine overall response rate (ORR), rates of local control, and distant metastases free survival with chemoradiation +/- atezolizumab.\n\nIII. To characterize immune mediated and non-immune mediated toxicity from chemoradiotherapy plus atezolizumab.\n\nIV. To compare quality of life, as measured by the Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI), for patients undergoing chemoradiation +/- atezolizumab.\n\nV. To evaluate the quality-adjusted survival, using scores from the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L), of chemoradiation +/- atezolizumab for patients with LS-SCLC.\n\nVI. To characterize fatigue, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS), following chemoradiation +/- atezolizumab.\n\nVII. To determine the association of small cell lung cancer (SCLC) molecular subtypes with clinical outcomes.\n\nEXPLORATORY OBJECTIVES:\n\nI. To collect biospecimens at baseline, day 1 and 3 months after the end of chemoradiotherapy, to allow for future analyses.\n\nII. To characterize patient-reported symptomatic toxicities measured by the Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE).\n\nIII. To characterize the concordance between tumor and circulating cell-free deoxyribonucleic acid (cfDNA)-determined molecular subtypes.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive etoposide intravenously (IV) on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) twice daily (BID) for approximately 3 weeks or once daily (QD) for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.\n\nARM II: Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.\n\nAfter completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer \\[AJCC\\] staging, 8th edition \\[Ed.\\]), within 60 days prior to registration\n* Patients must have received one cycle of platinum/etoposide chemotherapy pre-registration (prior to study entry). Study registration must be within 21 days from day 1 of the pre-registration cycle of chemotherapy.\n* Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors \\[RECIST\\], version 1.1) prior to the required pre-registration cycle of platinum/etoposide chemotherapy\n* Minimal staging requirements include:\n\n * History/physical examination within 30 days prior to registration\n * Positron emission tomography (PET)/computed tomography (CT) scan for staging within 60 days prior to registration\n * CT chest and CT abdomen with IV contrast (unless contraindicated based on kidney function) within 60 days prior to registration; magnetic resonance imaging (MRI) abdomen with IV contrast allowed in place of CT abdomen\n\n * Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy\n * MRI scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1,500/cells/mm\\^3 (prior to pre-registration cycle)\n* Platelet count \\>= 100,000 cells/mm\\^3 (prior to pre-registration cycle)\n* Hemoglobin \\>= 9 g/dL (prior to pre-registration cycle)\n* Total bilirubin =\\< 1.5 x upper limit of normal (ULN) (prior to pre-registration cycle)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2.0 x ULN (prior to pre-registration cycle)\n* Adequate renal function within 30 days prior to registration defined as follows: Creatinine clearance \\>= 30 mL/min by the Cockcroft-Gault (C-G) equation\n* Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging\n* Negative serum pregnancy test within 14 days of registration for pre-menopausal women of childbearing potential\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n* Hepatitis B/C testing prior to enrollment for patients that have not been tested before. Note: This is required even if the patient has never shown or had symptoms of hepatitis\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n\nExclusion Criteria:\n\n* Definitive clinical or radiologic evidence of metastatic disease\n* Definitive surgical resection of small cell lung cancer\n* Prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible)\n* More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable\n* Any prior atezolizumab or other immunotherapy agent\n* Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study principal investigators (PIs)\n* Patients with cytologically positive pleural or pericardial fluid are not eligible\n* An active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger\n* Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)\n* History of allogeneic organ transplant\n* History of primary immunodeficiency\n* Severe, active co-morbidity defined as follows:\n\n * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease\n * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications\n * Active tuberculosis\n * Active hepatitis B (chronic or acute) or hepatitis C infection. Note that if hepatitis status is unknown, hepatitis B/C testing is required\n\n * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\]) test, a positive anti-HBc (antibody to hepatitis B core antigen), and a negative viral deoxyribonucleic acid (DNA) test (only obtained if HBsAg is found positive) are eligible\n * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test.)\n * Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL)\n * Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of \\> 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary\n * Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months\n * Transmural myocardial infarction within the last 3 months\n * Clinically significant interstitial lung disease\n* A condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the duration of study treatment and for 150 days after the last dose of study drug (Arm 2); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic."}, 'identificationModule': {'nctId': 'NCT03811002', 'briefTitle': 'Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC)', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab', 'orgStudyIdInfo': {'id': 'NCI-2019-00178'}, 'secondaryIdInfos': [{'id': 'NCI-2019-00178', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'NRG-LU005', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'NRG-LU005', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180868', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180868', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (chemotherapy, radiation therapy)', 'description': 'Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.', 'interventionNames': ['Radiation: 3-Dimensional Conformal Radiation Therapy', 'Procedure: Biospecimen Collection', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Etoposide', 'Radiation: Intensity-Modulated Radiation Therapy', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (chemotherapy, radiation therapy, atezolizumab)', 'description': 'Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.', 'interventionNames': ['Radiation: 3-Dimensional Conformal Radiation Therapy', 'Drug: Atezolizumab', 'Procedure: Biospecimen Collection', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Etoposide', 'Radiation: Intensity-Modulated Radiation Therapy', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': '3-Dimensional Conformal Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['3-dimensional radiation therapy', '3D Conformal', '3D CONFORMAL RADIATION THERAPY', '3D CRT', '3D radiotherapy', '3D-CRT', 'Conformal Therapy', 'Radiation Conformal Therapy', 'Radiation, 3D Conformal', 'Three dimensional external beam radiation therapy (procedure)'], 'description': 'Undergo 3D-CRT', 'armGroupLabels': ['Arm I (chemotherapy, radiation therapy)', 'Arm II (chemotherapy, radiation therapy, atezolizumab)']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['MPDL 3280A', 'MPDL 328OA', 'MPDL-3280A', 'MPDL3280A', 'MPDL328OA', 'RG 7446', 'RG-7446', 'RG7446', 'RO 5541267', 'RO-5541267', 'RO5541267', 'Tecentriq'], 'description': 'Given IV', 'armGroupLabels': ['Arm II (chemotherapy, radiation therapy, atezolizumab)']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (chemotherapy, radiation therapy)', 'Arm II (chemotherapy, radiation therapy, atezolizumab)']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Blastocarb', 'Carboplat', 'Carboplatin Hexal', 'Carboplatino', 'Carboplatinum', 'Carbosin', 'Carbosol', 'Carbotec', 'CBDCA', 'Displata', 'Ercar', 'JM-8', 'JM8', 'Nealorin', 'Novoplatinum', 'Paraplatin', 'Paraplatin AQ', 'Paraplatine', 'Platinwas', 'Ribocarbo'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, radiation therapy)', 'Arm II (chemotherapy, radiation therapy, atezolizumab)']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Abiplatin', 'Blastolem', 'Briplatin', 'CDDP', 'Cis-diammine-dichloroplatinum', 'Cis-diamminedichloridoplatinum', 'Cis-diamminedichloro Platinum (II)', 'Cis-diamminedichloroplatinum', 'Cis-dichloroammine Platinum (II)', 'Cis-platinous Diamine Dichloride', 'Cis-platinum', 'Cis-platinum II', 'Cis-platinum II Diamine Dichloride', 'Cismaplat', 'Cisplatina', 'Cisplatinum', 'Cisplatyl', 'Citoplatino', 'Citosin', 'Cysplatyna', 'DDP', 'Lederplatin', 'Metaplatin', 'Neoplatin', "Peyrone's Chloride", "Peyrone's Salt", 'Placis', 'Plastistil', 'Platamine', 'Platiblastin', 'Platiblastin-S', 'Platinex', 'Platinol', 'Platinol- AQ', 'Platinol-AQ', 'Platinol-AQ VHA Plus', 'Platinoxan', 'Platinum', 'Platinum Diamminodichloride', 'Platiran', 'Platistin', 'Platosin'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, radiation therapy)', 'Arm II (chemotherapy, radiation therapy, atezolizumab)']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['Demethyl Epipodophyllotoxin Ethylidine Glucoside', 'EPEG', 'Lastet', 'Toposar', 'Vepesid', 'VP 16', 'VP 16-213', 'VP 16213', 'VP-16', 'VP-16-213', 'VP-16213', 'VP16', 'VP16213'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, radiation therapy)', 'Arm II (chemotherapy, radiation therapy, atezolizumab)']}, {'name': 'Intensity-Modulated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['IMRT', 'Intensity modulated radiation therapy (procedure)', 'Intensity Modulated RT', 'Intensity-Modulated Radiotherapy', 'Radiation, Intensity-Modulated Radiotherapy'], 'description': 'Undergo IMRT', 'armGroupLabels': ['Arm I (chemotherapy, radiation therapy)', 'Arm II (chemotherapy, radiation therapy, atezolizumab)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (chemotherapy, radiation therapy)', 'Arm II (chemotherapy, radiation therapy, atezolizumab)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (chemotherapy, radiation therapy)', 'Arm II (chemotherapy, radiation therapy, atezolizumab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '99701', 'city': 'Fairbanks', 'state': 'Alaska', 'country': 'United States', 'facility': 'Fairbanks Memorial Hospital', 'geoPoint': {'lat': 64.83778, 'lon': -147.71639}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85338', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'CTCA at Western Regional 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