Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT04921358
Status:
TERMINATED
Last Update Posted:
2025-06-29
First Post:
2021-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Germany', 'Italy', 'Netherlands', 'Spain', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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': 'C000707970', 'term': 'tislelizumab'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C000611865', 'term': 'sitravatinib'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@beigene.com', 'phone': '1-877-828-5568', 'title': 'Study Director', 'organization': 'BeiGene'}, 'certainAgreement': {'otherDetails': 'BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \\& may request a further delay to protect its IP rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality is reported from randomization until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive ( a median follow-up of approximately 8 months). Adverse events are reported from the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2).', 'description': 'All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.', 'otherNumAtRisk': 186, 'deathsNumAtRisk': 187, 'otherNumAffected': 181, 'seriousNumAtRisk': 186, 'deathsNumAffected': 92, 'seriousNumAffected': 83}, {'id': 'EG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.', 'otherNumAtRisk': 177, 'deathsNumAtRisk': 190, 'otherNumAffected': 150, 'seriousNumAtRisk': 177, 'deathsNumAffected': 82, 'seriousNumAffected': 66}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 85, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 163, 'numAffected': 84}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 18, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 54, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 24, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 43, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 191, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 37, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 39, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 40, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 45, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 19, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 17, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 168, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Alpha hydroxybutyrate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 195, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 21, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 37, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Blood creatine phosphokinase MB increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 107, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 29, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 74, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 16, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 41, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 54, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 162, 'numAffected': 54}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 58, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 47, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 65, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 201, 'numAffected': 62}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'White blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 62, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 33, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 35, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 39, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 85, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 60, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 40, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 31, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hypochloraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hypokalaemia', 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'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Scrotal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 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'sourceVocabulary': 'meddra 25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Neutrophil 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'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Bronchopleural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Immune-mediated lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Pulmonary infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra 25.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '14.6'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '15.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.39', 'estimateComment': 'Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\\<1% Tumor Cells (TC) vs \\>=1% TC).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the time from randomization until the date of death due to any cause. Kaplan-Meier methodology was used to estimate the median OS.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) analysis set consists of all participants who were randomized to a treatment arm.'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '5.7'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.07', 'estimateComment': 'Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\\<1% TC vs \\>=1% TC).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the time from randomization until first documentation of disease progression as assessed by the IRC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '5.6'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.83', 'estimateComment': 'Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\\<1% TC vs \\>=1% TC).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the time from randomization until first documentation of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '17.9'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '18.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the IRC per RECIST v1.1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '8.5'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the time from the first occurrence of a documented objective response to the time of the first occurrence of disease progression, as determined by the IRC based on RECIST v1.1, or death from any cause, whichever occurs first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis, and percentages were based on the number of responders.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000', 'lowerLimit': '62.4', 'upperLimit': '76.0'}, {'value': '53.7', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '60.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease per RECIST v1.1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) and Physical Functioning Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}], 'classes': [{'title': 'Global Health Status at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '16.05', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '18.69', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status at Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.1', 'spread': '15.86', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '17.25', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '12.76', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '15.89', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning at Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '12.30', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '16.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)', 'description': 'The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT Analysis Set with available at Baseline and each postbaseline visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}], 'classes': [{'title': 'Coughing at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '30.09', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '27.61', 'groupId': 'OG001'}]}]}, {'title': 'Coughing at Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '25.08', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '29.49', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '19.09', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '16.76', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea at Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '14.66', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '14.43', 'groupId': 'OG001'}]}]}, {'title': 'Chest Pain at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '24.45', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '20.21', 'groupId': 'OG001'}]}]}, {'title': 'Chest Pain at Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '22.43', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '16.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)', 'description': 'The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores indicate an improvement in symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT Analysis Set with available data at Baseline and each postbaseline visit'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}], 'classes': [{'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.1', 'spread': '14.27', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '13.76', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': '12.31', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '12.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)', 'description': "The EQ-5D-5L comprises a descriptive module that includes five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a Visual Analogue Scale. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The VAS records a participant's self-rated health on a vertical scale from 0 to 100, where 0 is 'the worst health you can imagine and 100 is 'the best health you can imagine'. A higher score indicates better health outcomes.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT Analysis Set with available at Baseline and each postbaseline visit'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2).', 'description': 'Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set includes all participants who were randomized and received any dose of any study drug'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'FG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '190'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '190'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '82'}]}]}], 'recruitmentDetails': 'Participants were enrolled across multiple study centers in China and Australia. The first participant was dosed on July 27th, 2021, and the last participant completed the study on December 20th, 2023. A decision to terminate the study was made on September 25th, 2023.', 'preAssignmentDetails': 'Patients were randomized in a 1:1 ratio to one of two treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily.'}, {'id': 'BG001', 'title': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel every 3 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '8.43', 'groupId': 'BG000'}, {'value': '61.3', 'spread': '8.77', 'groupId': 'BG001'}, {'value': '61.3', 'spread': '8.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Histology', 'classes': [{'title': 'Squamous', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}, {'title': 'Non-squamous', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PD-L1 Expression Status', 'classes': [{'title': '>= 1% Tumor Cells', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': '< 1% Tumor Cells', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants whose tissues were unevaluable for PD-L1 expression were included in the \\< 1% tumor cells group during randomization stratification.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-Treat (ITT) analysis set consists of all participants who were randomized to a treatment arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-09', 'size': 2912341, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-25T16:23', 'hasProtocol': True}, {'date': '2023-11-09', 'size': 959866, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-25T16:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 377}}, 'statusModule': {'whyStopped': 'Due to safety risks and unfavorable risk-benefit assessment results, the sponsor has decided to voluntarily terminate the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2021-05-25', 'resultsFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2021-06-07', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-11', 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the time from randomization until the date of death due to any cause. Kaplan-Meier methodology was used to estimate the median OS.'}, {'measure': 'Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the time from randomization until first documentation of disease progression as assessed by the IRC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS) as Assessed by the Investigator', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the time from randomization until first documentation of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occured first. Kaplan-Meier methodology was used to estimate the median PFS.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the IRC per RECIST v1.1.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the time from the first occurrence of a documented objective response to the time of the first occurrence of disease progression, as determined by the IRC based on RECIST v1.1, or death from any cause, whichever occurs first.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months).', 'description': 'Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease per RECIST v1.1.'}, {'measure': 'Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) and Physical Functioning Scores', 'timeFrame': 'Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)', 'description': 'The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life.'}, {'measure': 'Change From Baseline in EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scales', 'timeFrame': 'Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)', 'description': 'The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores indicate an improvement in symptoms.'}, {'measure': 'Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) Visual Analogue Scale (VAS)', 'timeFrame': 'Baseline and Cycle 5 Day 1 (Week 12) and Cycle 7 Day 1 (Week 18)', 'description': "The EQ-5D-5L comprises a descriptive module that includes five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a Visual Analogue Scale. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The VAS records a participant's self-rated health on a vertical scale from 0 to 100, where 0 is 'the worst health you can imagine and 100 is 'the best health you can imagine'. A higher score indicates better health outcomes."}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From the first dose through 30 days after the final dose or until new anticancer therapy, whichever came first, (a median treatment duration of approximately 4 months in Arm 1 and 2 months in Arm 2).', 'description': 'Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer (NSCLC)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Zhou Q, Zhao J, Gao B, et al. SAFFRON-301: A Phase 3 Study of Tislelizumab With Sitravatinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy and an Anti-PD-1/PD-L1 Antibody. Poster presented at: ESMO Congress 2022; September, 2022; Paris, France.'}, {'type': 'RESULT', 'citation': 'Zhou Q, Gao B, et al. SAFFRON-301: Sitravatinib PLUS Tislelizumab in Advanced/Metastatic NSCLC Progressing on/after Chemotherapy and Anti-PD-(L)1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared to docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who experienced disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody treatment, with the anti-PD-(L)1 antibody administered either in combination with or sequentially before or after the platinum-based chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Metastatic or unresectable locally advanced histologically or cytologically confirmed Non-Small Cell Lung Cancer (NCSLC), not amenable to treatment with curative intent\n2. Able to provide archival/fresh tumor tissues for biomarker analysis to assess PD-L1 expression and other biomarkers.\n3. No known Epidermal Growth Factor Receptor (EGFR) or B-Raf proto-oncogene (BRAF) sensitizing mutation, or anaplastic lymphoma kinase (ALK) rearrangement or ROS proto oncogene 1 (ROS1) rearrangement\n4. Radiographic progression per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 on or after anti-PD-(L)1 containing therapy for locally advanced and unresectable or metastatic NSCLC.\n5. No prior anticancer therapy having the same mechanism of action as sitravatinib (eg, tyrosine kinase inhibitor with a similar target profile or vascular endothelial growth factor (VEGF)- or VEGFR inhibitor)\n6. At least 1 measurable lesion as defined based on RECIST v1.1 by investigator\n\nKey Exclusion Criteria:\n\n1. Has received docetaxel as monotherapy or in combination with other therapies.\n2. Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (\\> 50 mL/day)\n3. Participants with tumor shown by imaging to be located around important vascular structures or if the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding.\n4. Active leptomeningeal disease for metastatic NSCLC, or uncontrolled or untreated brain metastasis.\n5. Active autoimmune diseases or history of autoimmune diseases that may relapse.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04921358', 'briefTitle': 'Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeiGene'}, 'officialTitle': 'A Randomized Phase 3 Study of Tislelizumab in Combination With Sitravatinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Progressed on or After Platinum-Based Chemotherapy and Anti-PD-(L)1 Antibody', 'orgStudyIdInfo': {'id': 'BGB-A317-Sitravatinib-301'}, 'secondaryIdInfos': [{'id': '2022-001779-15', 'type': 'EUDRACT_NUMBER'}, {'id': 'SAFFRON-301', 'type': 'OTHER', 'domain': 'BeiGene'}, {'id': 'CTR20211410/CTR20211409', 'type': 'OTHER', 'domain': 'ChinaDrugTrials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tislelizumab + Sitravatinib', 'description': 'Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier.', 'interventionNames': ['Drug: Tislelizumab', 'Drug: Sitravatinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Docetaxel', 'description': 'Participants received 75 mg/m² of intravenous docetaxel once every 3 weeks until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier.', 'interventionNames': ['Drug: Docetaxel']}], 'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'otherNames': ['BGB-A317'], 'description': '200 mg intravenously once every 3 weeks', 'armGroupLabels': ['Tislelizumab + Sitravatinib']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': '75 mg/m\\^2 intravenously once every 3 weeks', 'armGroupLabels': ['Docetaxel']}, {'name': 'Sitravatinib', 'type': 'DRUG', 'otherNames': ['BGB-9468'], 'description': '100 mg orally once daily', 'armGroupLabels': ['Tislelizumab + Sitravatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2148', 'city': 'Blacktown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Blacktown Cancer and Haematology Centre', 'geoPoint': {'lat': -33.76667, 'lon': 150.91667}}, {'zip': '2560', 'city': 'Campbelltown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Campbelltown Hospital', 'geoPoint': {'lat': -34.06667, 'lon': 150.81667}}, {'zip': '2487', 'city': 'Cudgen', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'The Tweed Valley Hospital', 'geoPoint': {'lat': -28.26667, 'lon': 153.55}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St George Hospital', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '4217', 'city': 'Benowa', 'state': 'Queensland', 'country': 'Australia', 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