Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT04988295
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2021-07-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}}}}, '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': 'C000707992', 'term': 'lazertinib'}, {'id': 'C000718215', 'term': 'amivantamab'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Executive Medical Director', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'Study site and investigator shall not publish study results except as required by law or as specified in a separate, written agreement between the sponsor and the study site or the investigator.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Cycle 1 Day 1 up to 1 year 7 months', 'description': 'SAEs \\& Other AEs:safety set-randomized participants who had at least 1 dose of study drug. All-cause mortality:FAS-all randomized participants, classified per assigned drug regardless of actual drug received. As per statistical analysis, Arm A AE planned to be collected and analyzed as single arm regardless of regimen LACP/ACP-L received. Since extension cohort is ongoing and its data collection and analysis was not planned for primary analysis, AE data will be reported after study completion.', 'eventGroups': [{'id': 'EG000', 'title': 'Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)', 'description': 'LACP dosing (study start until 6 November 2022): Participants received Lazertinib 240 milligrams (mg) orally on Day 1 of each subsequent cycle, starting with Cycle 3, along with Amivantamab 1400 mg (1750 mg if body weight greater than or equal to \\[\\>=80\\] kilograms \\[kg\\]) on Cycle 1 Days 1, 2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \\>=80 kg). Participant also received Pemetrexed 500 mg per square meter (mg/m\\^2) on Day 1 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants received Amivantamab 1400 mg (1750 mg if body weight \\>=80\\] kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \\>=80 kg). Participant also received Pemetrexed 500 mg/m\\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. Lazertinib 240 mg in ACP-L started on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.', 'otherNumAtRisk': 263, 'deathsNumAtRisk': 263, 'otherNumAffected': 261, 'seriousNumAtRisk': 263, 'deathsNumAffected': 69, 'seriousNumAffected': 137}, {'id': 'EG001', 'title': 'Main Study: Arm B: Carboplatin + Pemetrexed (CP)', 'description': 'Participants received Pemetrexed 500 mg/m\\^2 IV infusion and carboplatin 750 mg IV infusion from Day 1 of Cycle 1 to 4. From cycle 5 onwards, participants received Pemetrexed 500 mg/m\\^2 IV infusion, as maintenance until disease progression. Each cycle consists of 21 days.', 'otherNumAtRisk': 243, 'deathsNumAtRisk': 263, 'otherNumAffected': 222, 'seriousNumAtRisk': 243, 'deathsNumAffected': 65, 'seriousNumAffected': 49}, {'id': 'EG002', 'title': 'Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)', 'description': 'Participants received Amivantamab 1400 mg (1750 mg if body weight \\>=80 kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \\>=80 kg) on Day 1 of each cycle, starting with Cycle 3. Participants also received Pemetrexed 500 mg/m\\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab and Pemetrexed IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 131, 'otherNumAffected': 129, 'seriousNumAtRisk': 130, 'deathsNumAffected': 27, 'seriousNumAffected': 42}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 173}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 98}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 73}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 57}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 96}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 50}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 37}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 125}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 56}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dermatitis Acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Rash Maculo-Papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 142}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 74}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 40}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Blood Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Gamma-Glutamyltransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Blood Creatinine Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Productive Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Electrolyte Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Optic Neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Depressed Level of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Subarachnoid Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Subdural Hygroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Renal Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Bladder Dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Aseptic Pustule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dermatitis Acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Panniculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Skin Toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Main Study: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)', 'description': 'LACP dosing (study start until 6 November 2022): Participants received Lazertinib 240 milligrams (mg) orally on Day 1 of each subsequent cycle, starting with Cycle 3, along with Amivantamab 1400 mg (1750 mg if body weight greater than or equal to \\[\\>=80\\] kilograms \\[kg\\]) on Cycle 1 Days 1, 2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \\>=80 kg). Participant also received Pemetrexed 500 mg per square meter (mg/m\\^2) on Day 1 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants received Amivantamab 1400 mg (1750 mg if body weight \\>=80\\] kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \\>=80 kg). Participant also received Pemetrexed 500 mg/m\\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. Lazertinib 240 mg in ACP-L started on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.'}, {'id': 'OG001', 'title': 'Main Study: Arm B: Carboplatin + Pemetrexed (CP)', 'description': 'Participants received Pemetrexed 500 mg/m\\^2 IV infusion and carboplatin 750 mg IV infusion from Day 1 of Cycle 1 to 4. From cycle 5 onwards, participants received Pemetrexed 500 mg/m\\^2 IV infusion, as maintenance until disease progression. Each cycle consists of 21 days.'}, {'id': 'OG002', 'title': 'Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)', 'description': 'Participants received Amivantamab 1400 mg (1750 mg if body weight \\>=80 kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \\>=80 kg) on Day 1 of each cycle, starting with Cycle 3. Participants also received Pemetrexed 500 mg/m\\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab and Pemetrexed IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.31', 'groupId': 'OG000', 'lowerLimit': '6.77', 'upperLimit': '9.10'}, {'value': '4.17', 'groupId': 'OG001', 'lowerLimit': '4.04', 'upperLimit': '4.44'}, {'value': '6.28', 'groupId': 'OG002', 'lowerLimit': '5.55', 'upperLimit': '8.41'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '0.35', 'ciUpperLimit': '0.56', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.64', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months)', 'description': 'PFS is defined as the time from randomization until the date of objective disease progression or death, whichever came first, as assessed by BICR according to RECIST version 1.1. Progressed disease: Sum of diameters increased by greater than or equal to (\\>=)20 percent (%) and \\>=5 millimeter (mm) from nadir (including baseline if it was smallest sum).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) as defined in the protocol included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received. The outcomes reported here are for main study participants. For Arm A participants, data were planned to be analyzed as a single arm collectively for the LACP and ACP-L dosing regimens.'}, {'type': 'PRIMARY', 'title': 'Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'up to 4 years 10 months', 'description': 'Follow-up for the extension cohort is still ongoing and thus results from the analysis that includes the extension cohort will be reported up on study completion.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Objective Response Rate as Assessed by Blinded Independent Central Review', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Overall Survival', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Duration of Response as Assessed by Blinded Independent Central Review', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Time to Subsequent Therapy', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Progression-free Survival (PFS) After First Subsequent Therapy (PFS2)', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Time to Symptomatic Progression', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Intracranial Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study: Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Number of Participants With Adverse Events (AEs) by Severity', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Number of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Serum Concentration of Amivantamab', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Plasma Concentration of Lazertinib', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study + Extension Cohort: Number of Participants With Serum Anti-amivantamab Antibodies', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Change From Baseline With Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ)', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Change From Baseline With European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'SECONDARY', 'title': 'Main Study+ Extension Cohort: Change From Baseline With Patient-Reported Outcomes Measurement Information System -Physical Function (PROMIS-PF)', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}, {'type': 'PRIMARY', 'title': 'Main Study + Extension Cohort: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review', 'timeFrame': 'Up to 4 years 10 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-09'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)', 'description': "Schedule 1:LACP:study start to 06-Nov-2022:Lazertinib 240 milligrams(mg) orally daily along with amivantamab and chemotherapy (carboplatin and pemetrexed). Amivantamab 1400 mg (1750 mg if body weight\\>= 80 kilograms\\[kg\\]) intravenous(IV) infusion on Cycle 1 Days 1/2, 8 and 15 and Cycle 2 Day 1 and then 1750 mg (2100 mg if body weight \\>=80 kg) on Day 1 of each 21-day cycle, starting at cycle 3. Participants received chemotherapy:pemetrexed 500 milligrams per meter square(mg/m\\^2) IV infusion on Day 1 of each 21-day cycle, along with carboplatin area under concentration-time curve of 5 (AUC 5) IV infusion on Day 1 for up to 4 cycles and then as maintenance monotherapy until disease progression(DP). Schedule 2:ACP-L:07-Nov-2022 to study end:Amivantamab 1400 mg (1750 mg if body weight\\>=80 kg) IV infusion on Cycle 1 Days 1/2, 8 and 15 and Cycle 2 Day 1 and then 1750 mg (2100 mg if body weight \\>=80 kg) on Day 1 of each 21-day cycle, starting at cycle 3. Participants also received chemotherapy:pemetrexed 500 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle, along with carboplatin AUC 5 IV infusion on Day 1 for up to 4 cycles and then as maintenance monotherapy until DP. Lazertinib was administered 240 mg orally, once daily starting Cycle 5 Day 1 or sooner if carboplatin was discontinued earlier. In both schedules, Lazertinib, amivantamab and pemetrexed:continued until DP, participant withdrawal, adverse event, investigator's decision/initiation of new systemic anti-cancer treatment."}, {'id': 'FG001', 'title': 'Main Study: Arm B: Carboplatin + Pemetrexed (CP)', 'description': "Participants received chemotherapy with pemetrexed 500 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 mg/mL per minute (AUC 5) was administered as an IV infusion on Day 1, for up to 4 cycles, and then as maintenance monotherapy until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment."}, {'id': 'FG002', 'title': 'Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)', 'description': "Participants received amivantamab 1400 mg (1750 mg if body weight is \\>= 80 kg) by IV infusion once weekly starting from Cycle 1 Days 1/2, 8, and 15, and Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \\>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3. Participants also received chemotherapy with pemetrexed 500 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 mg/mL per minute (AUC 5) was administered as an IV infusion on Day 1, for up to 4 cycles. Amivantamab and pemetrexed treatments were to be continued until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment."}, {'id': 'FG003', 'title': 'Extension Cohort: All Participants (Arm A2 [ACP-L] + C2 [ACP])', 'description': "In Arm A2, participants received amivantamab 1400 mg (1750 mg if body weight\\>=80 kg) IV infusion once weekly from Cycle 1 Days 1/2, 8, and 15, and Cycle 2 Day 1, and then 1750 mg (2100 mg if body weight \\>=80 kg) on Day 1 of each 21-day cycle, starting at cycle 3. Participants also received chemotherapy: pemetrexed 500 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle, in combination with carboplatin area under concentration-time curve of 5 mg/mL per minute (AUC 5) IV infusion administered on Day 1 for up to 4 cycles. Lazertinib was administered 240 mg orally, once daily starting Cycle 5 Day 1 or sooner if carboplatin was discontinued earlier. Amivantamab, pemetrexed and lazertinib were to be continued until disease progression (DP), participant withdrawal, adverse event (AE), investigator's decision or initiation of new systemic anti-cancer treatment. In Arm C2, participants received amivantamab 1400 mg (1750 mg if body weight \\>=80 kg) IV infusion once weekly from Cycle 1 Days 1/2, 8, and 15, and Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \\>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3. Participants also received chemotherapy: pemetrexed 500 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle, in combination with carboplatin AUC 5 IV infusion was administered on Day 1, for up to 4 cycles. Amivantamab and pemetrexed were to be continued until DP, participant withdrawal, AE, investigator's decision or initiation of new systemic anti-cancer treatment."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '263'}, {'groupId': 'FG002', 'numSubjects': '131'}, {'groupId': 'FG003', 'numSubjects': '119'}]}, {'type': 'Treated (Safety Analysis Set)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '243'}, {'groupId': 'FG002', 'numSubjects': '130'}, {'groupId': 'FG003', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'comment': 'As per protocol, participants who died were also considered as completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '198'}, {'groupId': 'FG002', 'numSubjects': '105'}, {'groupId': 'FG003', 'numSubjects': '119'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Study participation ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '119'}]}]}], 'recruitmentDetails': 'A total of 657 participants were enrolled in the main study. During the study, a separate open-label randomized extension cohort was added. A total of 119 participants were enrolled into the extension cohort. Main study results are alone reported for primary completion date (PCD; 10-July-2023).', 'preAssignmentDetails': 'At the time of PCD, extension cohort enrollment was still ongoing. As per protocol, extension cohort analysis was not included as part of main study primary analysis. Currently no information other than total count of participants for extension cohort is available and for reporting purpose extension cohort arms (A2 and C2) have been combined in the table. Results of extension cohort will be reported later, upon completion of analysis, at which point arms A2 and C2 details will be reported.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '657', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)', 'description': 'LACP dosing (study start until 6 November 2022): Participants received Lazertinib 240 milligrams (mg) orally on Day 1 of each subsequent cycle, starting with Cycle 3, along with Amivantamab 1400 mg (1750 mg if body weight greater than or equal to \\[\\>=80\\] kilograms \\[kg\\]) on Cycle 1 Days 1, 2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \\>=80 kg). Participant also received Pemetrexed 500 mg per square meter (mg/m\\^2) on Day 1 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants received Amivantamab 1400 mg (1750 mg if body weight \\>=80\\] kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \\>=80 kg). Participant also received Pemetrexed 500 mg/m\\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. Lazertinib 240 mg in ACP-L started on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.'}, {'id': 'BG001', 'title': 'Main Study: Arm B: Carboplatin + Pemetrexed (CP)', 'description': 'Participants received Pemetrexed 500 mg/m\\^2 IV infusion and carboplatin 750 mg IV infusion from Day 1 of Cycle 1 to 4. From cycle 5 onwards, participants received Pemetrexed 500 mg/m\\^2 IV infusion, as maintenance until disease progression. Each cycle consists of 21 days.'}, {'id': 'BG002', 'title': 'Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP)', 'description': 'Participants received Amivantamab 1400 mg (1750 mg if body weight \\>=80 kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \\>=80 kg) on Day 1 of each cycle, starting with Cycle 3. Participants also received Pemetrexed 500 mg/m\\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab and Pemetrexed IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.'}, {'id': 'BG003', 'title': 'Extension Cohort: All Participants (Arm A2 [ACP-L] + C2 [ACP])', 'description': "In Arm A2, participants received amivantamab 1400 mg (1750 mg if body weight\\>=80 kg) IV infusion once weekly from Cycle 1 Days 1/2, 8, and 15, and Cycle 2 Day 1, and then 1750 mg (2100 mg if body weight \\>=80 kg) on Day 1 of each 21-day cycle, starting at cycle 3. Participants also received chemotherapy: pemetrexed 500 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle, in combination with carboplatin area under concentration-time curve of 5 mg/mL per minute (AUC 5) IV infusion administered on Day 1 for up to 4 cycles. Lazertinib was administered 240 mg orally, once daily starting Cycle 5 Day 1 or sooner if carboplatin was discontinued earlier. Amivantamab, pemetrexed and lazertinib were to be continued until disease progression (DP), participant withdrawal, adverse event (AE), investigator's decision or initiation of new systemic anti-cancer treatment. In Arm C2, participants received amivantamab 1400 mg (1750 mg if body weight \\>=80 kg) IV infusion once weekly from Cycle 1 Days 1/2, 8, and 15, and Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \\>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3. Participants also received chemotherapy: pemetrexed 500 mg/m\\^2 IV infusion on Day 1 of each 21-day cycle, in combination with carboplatin AUC 5 IV infusion was administered on Day 1, for up to 4 cycles. Amivantamab and pemetrexed were to be continued until DP, participant withdrawal, AE, investigator's decision or initiation of new systemic anti-cancer treatment."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'spread': '10.96', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '10.13', 'groupId': 'BG001'}, {'value': '61.2', 'spread': '10.06', 'groupId': 'BG002'}, {'value': '60.6', 'spread': '10.44', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '251', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '586', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '315', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '312', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'ARGENTINA', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG004'}]}]}, {'title': 'BRAZIL', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG004'}]}]}, {'title': 'BULGARIA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG004'}]}]}, {'title': 'CHINA', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG004'}]}]}, {'title': 'CZECH REPUBLIC', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG004'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'HONG KONG', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'INDIA', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG004'}]}]}, {'title': 'ISRAEL', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG004'}]}]}, {'title': 'JAPAN', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG004'}]}]}, {'title': 'MALAYSIA', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'MEXICO', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'NETHERLANDS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': 'PORTUGAL', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'RUSSIAN FEDERATION', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'SOUTH KOREA', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG004'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG004'}]}]}, {'title': 'SWEDEN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'TAIWAN', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG004'}]}]}, {'title': 'TURKEY', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'UNITED KINGDOM', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For extension cohort, data was not available at the time of primary analysis results reporting. Hence, enrollment data was reported only for main study.'}], 'populationDescription': 'Only main study (N=657) results are reported, thus column "Total participants" presents main study data. Per protocol, extension cohort analysis was not included in main study primary analysis. Extension cohort results will be reported later, upon analysis completion, at which point arms A2 and C2 details will be reported. For reporting purpose of extension cohort at this time since data is still not available, single combined arm for extension cohort (A2/C2) is presented with \'0\' participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-05', 'size': 5594933, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-16T04:39', 'hasProtocol': True}, {'date': '2023-05-19', 'size': 1727816, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-16T04:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 776}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04599712', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2024-07-05', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2021-07-30', 'resultsFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2021-07-30', 'dispFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-03-27', 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main Study: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)', 'timeFrame': 'From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months)', 'description': 'PFS is defined as the time from randomization until the date of objective disease progression or death, whichever came first, as assessed by BICR according to RECIST version 1.1. Progressed disease: Sum of diameters increased by greater than or equal to (\\>=)20 percent (%) and \\>=5 millimeter (mm) from nadir (including baseline if it was smallest sum).'}, {'measure': 'Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'up to 4 years 10 months', 'description': 'Follow-up for the extension cohort is still ongoing and thus results from the analysis that includes the extension cohort will be reported up on study completion.'}, {'measure': 'Main Study + Extension Cohort: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review', 'timeFrame': 'Up to 4 years 10 months'}], 'secondaryOutcomes': [{'measure': 'Main Study+ Extension Cohort: Objective Response Rate as Assessed by Blinded Independent Central Review', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Overall Survival', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Duration of Response as Assessed by Blinded Independent Central Review', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Time to Subsequent Therapy', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Progression-free Survival (PFS) After First Subsequent Therapy (PFS2)', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Time to Symptomatic Progression', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Intracranial Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study: Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Number of Participants With Adverse Events (AEs) by Severity', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Number of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Serum Concentration of Amivantamab', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Plasma Concentration of Lazertinib', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study + Extension Cohort: Number of Participants With Serum Anti-amivantamab Antibodies', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Change From Baseline With Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ)', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Change From Baseline With European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)', 'timeFrame': 'Up to 4 years 10 months'}, {'measure': 'Main Study+ Extension Cohort: Change From Baseline With Patient-Reported Outcomes Measurement Information System -Physical Function (PROMIS-PF)', 'timeFrame': 'Up to 4 years 10 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated\n* Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation\n* A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease\n* Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \\[any grade\\], Grade \\<= 2 peripheral neuropathy, or Grade \\<= 2 hypothyroidism stable on hormone replacement)\n* A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study\n* Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8)\n\nExclusion Criteria:\n\n* Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization\n* Participant with symptomatic or progressive brain metastases\n* Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation\n* Participant has known small cell transformation\n* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis\n* Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines'}, 'identificationModule': {'nctId': 'NCT04988295', 'acronym': 'MARIPOSA-2', 'briefTitle': 'A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure', 'orgStudyIdInfo': {'id': 'CR109061'}, 'secondaryIdInfos': [{'id': '61186372NSC3002', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2021-001825-33', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-506518-33-00', 'type': 'REGISTRY', 'domain': 'EUCT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: LACP/ACP-L', 'description': 'LACP dosing (study start until 6 November 2022): Participants will receive Lazertinib orally along with Amivantamab, Pemetrexed, and Carboplatin as IV infusion starting on Cycle 1 Day 1 for 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants will receive Amivantamab, Pemetrexed, and Carboplatin starting on Cycle 1 Day 1 for 4 cycles. Lazertinib in ACP-L will start on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4 (each cycle consists of 21 days). Beginning with Cycle 5 Day 1, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression.', 'interventionNames': ['Drug: Lazertinib', 'Drug: Amivantamab', 'Drug: Pemetrexed', 'Drug: Carboplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: CP (Carboplatin and Pemetrexed)', 'description': 'Participants will receive Pemetrexed in combination with Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Pemetrexed as maintenance until disease progression.', 'interventionNames': ['Drug: Pemetrexed', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)', 'description': 'Participants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.', 'interventionNames': ['Drug: Amivantamab', 'Drug: Pemetrexed', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm A2 (Extension Cohort): ACP-L', 'description': 'Participants will receive Amivantamab, Pemetrexed and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days), Lazertinib will start on C5D1 or sooner if carboplatin is discontinued earlier). After 4 cycles, participants will receive Pemetrexed, Amivantamab, Lazertinib as maintenance until disease progression.', 'interventionNames': ['Drug: Lazertinib', 'Drug: Amivantamab', 'Drug: Pemetrexed', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C2 (Extension Cohort): ACP', 'description': 'Participants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.', 'interventionNames': ['Drug: Amivantamab', 'Drug: Pemetrexed', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Lazertinib', 'type': 'DRUG', 'otherNames': ['JNJ-73841937', 'YH-25448'], 'description': 'Lazertinib will be administered orally.', 'armGroupLabels': ['Arm A2 (Extension Cohort): ACP-L', 'Arm A: LACP/ACP-L']}, {'name': 'Amivantamab', 'type': 'DRUG', 'otherNames': ['JNJ-61186372'], 'description': 'Amivantamab will be administered as an IV infusion.', 'armGroupLabels': ['Arm A2 (Extension Cohort): ACP-L', 'Arm A: LACP/ACP-L', 'Arm C2 (Extension Cohort): ACP', 'Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Pemetrexed will be administered as an IV infusion.', 'armGroupLabels': ['Arm A2 (Extension Cohort): ACP-L', 'Arm A: LACP/ACP-L', 'Arm B: CP (Carboplatin and Pemetrexed)', 'Arm C2 (Extension Cohort): ACP', 'Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin will be administered as an IV infusion.', 'armGroupLabels': ['Arm A2 (Extension Cohort): ACP-L', 'Arm A: LACP/ACP-L', 'Arm B: CP (Carboplatin and Pemetrexed)', 'Arm C2 (Extension Cohort): ACP', 'Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center, PC', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'University Cancer And Blood Center LLC', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 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