Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-04-10 @ 10:35 AM
Study NCT ID:
NCT00981058
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2009-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, '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': 'C527969', 'term': 'necitumumab'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C569272', 'term': 'LY2334737'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline Up To 156 Months', 'description': 'All participants who received at least one dose of study drug. The adverse events were analyzed and reported according to the study treatments pre-specified in the statistical analysis plan.', 'eventGroups': [{'id': 'EG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.', 'otherNumAtRisk': 538, 'deathsNumAtRisk': 538, 'otherNumAffected': 518, 'seriousNumAtRisk': 538, 'deathsNumAffected': 476, 'seriousNumAffected': 262}, {'id': 'EG001', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.', 'otherNumAtRisk': 541, 'deathsNumAtRisk': 541, 'otherNumAffected': 512, 'seriousNumAtRisk': 541, 'deathsNumAffected': 487, 'seriousNumAffected': 208}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 221, 'numAffected': 221}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 246, 'numAffected': 246}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 71, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 85, 'numAffected': 85}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 220, 'numAffected': 220}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 229, 'numAffected': 229}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 103, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 124, 'numAffected': 124}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 111, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 101, 'numAffected': 101}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 84, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 60, 'numAffected': 60}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 265, 'numAffected': 265}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 284, 'numAffected': 284}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 58, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 153, 'numAffected': 153}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 134, 'numAffected': 134}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 125, 'numAffected': 125}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 112, 'numAffected': 112}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 117, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 121, 'numAffected': 121}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 44, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 42, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 70, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 61, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 49, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 41, 'numAffected': 41}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 73, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 162, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 153, 'numAffected': 153}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 159, 'numAffected': 159}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 82, 'numAffected': 82}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 55, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 42, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 57, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 93, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 72, 'numAffected': 72}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 93, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 79, 'numAffected': 79}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 49, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 76, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 70, 'numAffected': 70}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 80, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 252, 'numAffected': 252}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myelosuppression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pulmonary toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pulmonary venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Respiratory tract haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Skin toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Social stay hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Superficial vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Superior vena cava occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 538, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 541, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival Time (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '548', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}, {'id': 'OG001', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine + Cisplatin\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '12.6'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '11.1'}]}]}], 'analyses': [{'pValue': '0.0120', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.842', 'ciLowerLimit': '0.736', 'ciUpperLimit': '0.962', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to Death from Any Cause (Up to 31 Months)', 'description': 'Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 127, Gemcitabine + Cisplatin = 106'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '548', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}, {'id': 'OG001', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine + Cisplatin\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '6.0'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '5.6'}]}]}], 'analyses': [{'pValue': '0.0201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.851', 'ciLowerLimit': '0.743', 'ciUpperLimit': '0.975', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)', 'description': 'PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 114, Gemcitabine + Cisplatin = 131'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '548', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}, {'id': 'OG001', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine + Cisplatin\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000', 'lowerLimit': '27.4', 'upperLimit': '35.2'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '25.2', 'upperLimit': '32.8'}]}]}], 'analyses': [{'pValue': '0.3997', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.45', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Measured Progressive Disease (Up to 31 Months)', 'description': 'ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions. PR defined as a \\>=30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \\* 100.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure (TTF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '548', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}, {'id': 'OG001', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine + Cisplatin\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '4.8'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '4.1'}]}]}], 'analyses': [{'pValue': '0.0061', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.844', 'ciLowerLimit': '0.747', 'ciUpperLimit': '0.953', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)', 'description': 'TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death from any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 16, Gemcitabine + Cisplatin =20'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}, {'id': 'OG001', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine + Cisplatin\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0053', 'spread': '0.23626', 'groupId': 'OG000'}, {'value': '-0.0083', 'spread': '0.23866', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 6 (Cycle = 3 Weeks)', 'description': 'The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had evaluable baseline and postbaseline EQ-5D data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}, {'value': '548', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}, {'id': 'OG001', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine + Cisplatin\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}], 'classes': [{'title': 'Loss of Appetite (n=304, 242)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '31.84', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '29.30', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue (n=302, 242)', 'categories': [{'measurements': [{'value': '6.3', 'spread': '29.15', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '25.29', 'groupId': 'OG001'}]}]}, {'title': 'Cough (n=303, 243)', 'categories': [{'measurements': [{'value': '-7.8', 'spread': '28.05', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '25.74', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea (n=305, 244)', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '26.52', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '25.27', 'groupId': 'OG001'}]}]}, {'title': 'Pain (n=302, 243)', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '17.98', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '17.22', 'groupId': 'OG001'}]}]}, {'title': 'Overall Symptoms (n=303, 242)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '26.19', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '26.92', 'groupId': 'OG001'}]}]}, {'title': 'Interference (n=306,241)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '29.74', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '26.79', 'groupId': 'OG001'}]}]}, {'title': 'Quality of Life (n=305, 243)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '27.35', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '24.71', 'groupId': 'OG001'}]}]}, {'title': 'Average Symptom Burden Index (ASBI) (n=294, 234)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '16.55', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '16.52', 'groupId': 'OG001'}]}]}, {'title': 'LCSS Total Score (n=290, 228)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '17.03', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '16.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 6 (Cycle = 3 Weeks)', 'description': 'The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \\[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.', 'unitOfMeasure': 'millimeter (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had evaluable data for LCSS.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}, {'id': 'OG001', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine + Cisplatin\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': '>0', 'categories': [{'measurements': [{'value': '462', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}]}]}, {'title': '<200', 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}]}, {'title': '≥200', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '31 Months', 'description': 'EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of \\<200 and participants with a high EGFR expression defined by a H-score of cutoff value of \\>=200.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable data for EGFR IHC.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}], 'classes': [{'title': 'Predose Cycle 2 Day 1 (n=419)', 'categories': [{'measurements': [{'value': '52.4', 'spread': '95.9', 'groupId': 'OG000'}]}]}, {'title': 'Predose Cycle3 Day 1 (n=386)', 'categories': [{'measurements': [{'value': '76.6', 'spread': '80.6', 'groupId': 'OG000'}]}]}, {'title': 'Predose Cycle 4 Day 1 (n=344)', 'categories': [{'measurements': [{'value': '94.5', 'spread': '92.2', 'groupId': 'OG000'}]}]}, {'title': 'Predose Cycle 5 Day 1 (n=297)', 'categories': [{'measurements': [{'value': '101', 'spread': '90', 'groupId': 'OG000'}]}]}, {'title': 'Predose Cycle 6 Day 1 (n=262)', 'categories': [{'measurements': [{'value': '98.5', 'spread': '80', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months', 'unitOfMeasure': 'micrograms/milliliter (ug/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable data for PK.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Serum Anti-Necitumumab Antibody Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}], 'classes': [{'title': 'Participants with at least 1 positive titer', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Neutralizing antibody detected', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 31 Months', 'description': 'A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received who received at least 1 dose of drug and had evaluable data for antibodies.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}, {'id': 'FG001', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine + Cisplatin\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '545'}, {'groupId': 'FG001', 'numSubjects': '548'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '538'}, {'groupId': 'FG001', 'numSubjects': '541'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '476'}, {'groupId': 'FG001', 'numSubjects': '487'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '61'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Randomization Error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}], 'preAssignmentDetails': 'Completers are defined as those participants who died due to any cause in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'BG000'}, {'value': '548', 'groupId': 'BG001'}, {'value': '1093', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}, {'id': 'BG001', 'title': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine + Cisplatin\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '84'}, {'value': '62.0', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '86'}, {'value': '62.0', 'groupId': 'BG002', 'lowerLimit': '32', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '450', 'groupId': 'BG000'}, {'value': '458', 'groupId': 'BG001'}, {'value': '908', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '489', 'groupId': 'BG000'}, {'value': '490', 'groupId': 'BG001'}, {'value': '979', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '457', 'groupId': 'BG000'}, {'value': '456', 'groupId': 'BG001'}, {'value': '913', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': 'Philippines', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '332', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '652', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ECOG classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 1 participant with ECOG PS 3 was randomized to the Gemcitabine + Cisplatin arm but did not receive treatment.', 'unitOfMeasure': 'participants'}, {'title': 'Smoking History', 'classes': [{'title': 'Ex-Light Smoker', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Non-Smoker', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Smoker', 'categories': [{'measurements': [{'value': '500', 'groupId': 'BG000'}, {'value': '495', 'groupId': 'BG001'}, {'value': '995', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease Stage at Study Entry', 'classes': [{'title': 'Stage IIIB', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Stage IV', 'categories': [{'measurements': [{'value': '543', 'groupId': 'BG000'}, {'value': '546', 'groupId': 'BG001'}, {'value': '1089', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIB - the cancer has spread to nearby tissue or spread to far away lymph nodes. Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver.', 'unitOfMeasure': 'participants'}, {'title': 'Disease Histology', 'classes': [{'title': 'Squamous', 'categories': [{'measurements': [{'value': '543', 'groupId': 'BG000'}, {'value': '545', 'groupId': 'BG001'}, {'value': '1088', 'groupId': 'BG002'}]}]}, {'title': 'Other Histology', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sites of Metastatic Disease', 'classes': [{'title': 'Bone', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}]}, {'title': 'Brain', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}, {'title': 'Lung', 'categories': [{'measurements': [{'value': '453', 'groupId': 'BG000'}, {'value': '453', 'groupId': 'BG001'}, {'value': '906', 'groupId': 'BG002'}]}]}, {'title': 'Lymph Nodes', 'categories': [{'measurements': [{'value': '431', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '882', 'groupId': 'BG002'}]}]}, {'title': 'Peritoneal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Pleural', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}]}, {'title': 'Skin', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Soft Tissue', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants may record multiple sites of metastatic disease.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1093}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'dispFirstSubmitDate': '2010-09-07', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2009-09-18', 'dispFirstSubmitQcDate': '2010-09-07', 'resultsFirstSubmitDate': '2015-12-21', 'studyFirstSubmitQcDate': '2009-09-21', 'dispFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-20', 'studyFirstPostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival Time (OS)', 'timeFrame': 'Randomization to Death from Any Cause (Up to 31 Months)', 'description': 'Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)', 'description': 'PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.'}, {'measure': 'Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])', 'timeFrame': 'Baseline to Measured Progressive Disease (Up to 31 Months)', 'description': 'ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions. PR defined as a \\>=30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \\* 100.'}, {'measure': 'Time to Treatment Failure (TTF)', 'timeFrame': 'Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)', 'description': 'TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death from any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.'}, {'measure': 'Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)', 'timeFrame': 'Baseline, Cycle 6 (Cycle = 3 Weeks)', 'description': 'The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).'}, {'measure': 'Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)', 'timeFrame': 'Baseline, Cycle 6 (Cycle = 3 Weeks)', 'description': 'The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \\[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.'}, {'measure': 'Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)', 'timeFrame': '31 Months', 'description': 'EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of \\<200 and participants with a high EGFR expression defined by a H-score of cutoff value of \\>=200.'}, {'measure': 'Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab', 'timeFrame': 'Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months'}, {'measure': 'Number of Participants With a Serum Anti-Necitumumab Antibody Assessment', 'timeFrame': 'Baseline through 31 Months', 'description': 'A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Squamous', 'Non Small Cell Lung Cancer', 'First line treatment', 'Monoclonal', 'Antibodies', 'Epidermal Growth Factor Receptor (EGFR)'], 'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '29158123', 'type': 'DERIVED', 'citation': 'Ciuleanu T, Socinski MA, Obasaju C, Luft AV, Szczesna A, Szafranski W, Ramlau R, Balint B, Molinier O, Depenbrock H, Nanda S, Paz-Ares L, Thatcher N. Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Mar;19(2):130-138.e2. doi: 10.1016/j.cllc.2017.10.004. Epub 2017 Oct 13.'}, {'pmid': '27207107', 'type': 'DERIVED', 'citation': 'Paz-Ares L, Socinski MA, Shahidi J, Hozak RR, Soldatenkova V, Kurek R, Varella-Garcia M, Thatcher N, Hirsch FR. Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer. Ann Oncol. 2016 Aug;27(8):1573-9. doi: 10.1093/annonc/mdw214. Epub 2016 May 20.'}, {'pmid': '26980471', 'type': 'DERIVED', 'citation': 'Reck M, Socinski MA, Luft A, Szczesna A, Dediu M, Ramlau R, Losonczy G, Molinier O, Schumann C, Gralla RJ, Bonomi P, Brown J, Soldatenkova V, Chouaki N, Obasaju C, Peterson P, Thatcher N. The Effect of Necitumumab in Combination with Gemcitabine plus Cisplatin on Tolerability and on Quality of Life: Results from the Phase 3 SQUIRE Trial. J Thorac Oncol. 2016 Jun;11(6):808-18. doi: 10.1016/j.jtho.2016.03.002. Epub 2016 Mar 12.'}, {'pmid': '26045340', 'type': 'DERIVED', 'citation': 'Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Balint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. doi: 10.1016/S1470-2045(15)00021-2. Epub 2015 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.', 'detailedDescription': 'Multinational, randomized, multicenter, open-label, Phase III study of 1093 participants (age ≥ 18 years) with histologically- or cytologically-confirmed, stage IV squamous-cell NSCLC, who have received no prior therapy for metastatic disease, will be randomized on a 1:1 basis to receive first-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin in study Arm A, or gemcitabine-cisplatin chemotherapy alone in study Arm B. Baseline radiographic assessment of disease will be performed within 21 days prior to randomization (first treatment will be administered within 7 days following randomization). Participants will undergo radiographic assessment of disease status (computed tomography or magnetic resonance imaging) every 6 weeks (± 3 days), until there is radiographic documentation of progressive disease (PD). Chemotherapy will continue for a maximum of six cycles in each arm (or until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance or withdrawal of consent); participants in Arm A only will continue to receive necitumumab until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.\n\nAfter the end-of-study-visit (following PD), follow-up information regarding further anticancer treatment and survival will be collected every 2 months (± 7 days). For participants who discontinue study for reasons other than PD (eg, symptomatic deterioration), information on disease progression will also be collected until PD is documented. Follow-up will continue as long as the participant is alive, or until the end of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has histologically or cytologically confirmed squamous NSCLC\n* Has Stage IV disease at the time of study entry\n* Measurable or nonmeasurable disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) (participants with only truly nonmeasurable disease are not eligible)\n* Has resolution to Grade ≤ 1 of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia)\n* Has adequate hepatic function\n* Has adequate renal function\n* Has adequate hematologic function\n* If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method (failure rate \\< 1%) during and for 6 months after the treatment period (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method)\n* If male, the participant is surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period\n* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization\n* Has archived tumor tissue available for analysis of EGFR and KRAS mutation status (by PCR) and EGFR gene copy number (by FISH); minimum of four slides, paraffin-embedded tissue, required\n\nExclusion Criteria:\n\n* Has nonsquamous NSCLC (adenocarcinoma/large cell or other)\n* Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor\n* Has received previous chemotherapy for advanced NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 1 year prior to randomization)\n* Has undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization\n* Has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)\n* Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible\n* Has superior vena cava syndrome contraindicating hydration\n* Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure\n* Has experienced myocardial infarction within 6 months prior to randomization\n* Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus\n* Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder\n* Has any National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 Grade ≥ 2 peripheral neuropathy\n* Has significant third space fluid retention, requiring repeated drainage\n* Has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the participant's ability to complete the study or sign an informed consent document\n* Has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab (IMC-11F8), or any other contraindication to one of the administered treatments\n* Is pregnant or breastfeeding\n* Has a known history of drug abuse\n* Has a concurrent active malignancy other than adequately-treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years"}, 'identificationModule': {'nctId': 'NCT00981058', 'acronym': 'SQUIRE', 'briefTitle': 'First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': '13909'}, 'secondaryIdInfos': [{'id': 'CP11-0806', 'type': 'OTHER', 'domain': 'ImClone Systems'}, {'id': 'I4X-IE-JFCC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2009-013838-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Necitumumab + Gemcitabine + Cisplatin', 'description': 'Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.', 'interventionNames': ['Biological: Necitumumab', 'Drug: Gemcitabine', 'Drug: Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine + Cisplatin', 'description': 'Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Necitumumab', 'type': 'BIOLOGICAL', 'otherNames': ['IMC-11F8', 'LY3012211'], 'description': 'Administered intravenously.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.', 'armGroupLabels': ['Necitumumab + Gemcitabine + Cisplatin']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['LY2334737'], 'description': 'Administered intravenously.\n\nContinues for a maximum of six cycles.', 'armGroupLabels': ['Gemcitabine + Cisplatin', 'Necitumumab + Gemcitabine + Cisplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Administered intravenously.\n\nContinues for a maximum of six cycles.', 'armGroupLabels': ['Gemcitabine + Cisplatin', 'Necitumumab + Gemcitabine + Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 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