Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-01 @ 8:11 PM
Study NCT ID:
NCT05663866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2022-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C093875', 'term': 'montelukast'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C000718215', 'term': 'amivantamab'}, {'id': 'C000707992', 'term': 'lazertinib'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Senior Medical Director Global Medical Affair Oncology', 'organization': 'Janssen Research & Development LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)', 'description': 'Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A1: Dexamethasone 4 Milligrams (mg)', 'description': 'Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than \\[\\<\\] 80 kilograms \\[kg\\]) or 1400 mg (for participants greater than or equal to \\[\\>=\\] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cohort A2: Dexamethasone 8 mg', 'description': 'Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 41, 'seriousNumAtRisk': 41, 'deathsNumAffected': 4, 'seriousNumAffected': 20}, {'id': 'EG002', 'title': 'Cohort B: Montelukast 10 mg', 'description': 'Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Cohort C: Methotrexate 25 mg', 'description': 'Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dermatitis Acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Onycholysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Skin Fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Rash Pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Seborrhoeic Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Xeroderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Palmar-Plantar Erythrodysaesthesia Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Rash Erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Skin Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Gingival Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Mouth Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Haemorrhoidal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Mouth Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Osteoporotic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Femur Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Abnormal Behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Dexamethasone 4 Milligrams (mg)', 'description': 'Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than \\[\\<\\] 80 kilograms \\[kg\\]) or 1400 mg (for participants greater than or equal to \\[\\>=\\] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}, {'id': 'OG001', 'title': 'Cohort A2: Dexamethasone 8 mg', 'description': 'Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}, {'id': 'OG002', 'title': 'Cohort B: Montelukast 10 mg', 'description': 'Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}, {'id': 'OG003', 'title': 'Cohort C: Methotrexate 25 mg', 'description': 'Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '99.6'}, {'value': '22.5', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '38.5'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '38.4', 'upperLimit': '88.2'}, {'value': '83.3', 'groupId': 'OG003', 'lowerLimit': '35.9', 'upperLimit': '99.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Day 1 (each cycle of 28 days)', 'description': 'Percentage of participants with IRRs at Cycle 1 Day 1 was reported. IRRs were defined as IRR events with onset time within 24 hours of the start of the first amivantamab infusion and prior to the start of amivantamab infusion on Cycle 1 Day 2. IRR included chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever. IRRs that occurred on Cycle 1 Day 2 pre-infusion were considered under Cycle 1 Day 1.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per protocol analysis set included all participants who had received all prophylaxis treatment based on schedule and had received the administration of amivantamab and lazertinib on Cycle 1 Day 1.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events of Infusion-related Reactions (IRRs) During Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (each cycle of 28 days)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs) of Infusion-related Reactions (IRRs) as Per Severity up to End of Cycle 3 (Cycle 3 Day 28)', 'timeFrame': 'From Cycle 1 Day 1 up to Cycle 3 Day 28 (each cycle of 28 days)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With IRRs up to End of Treatment (EOT)', 'timeFrame': 'From Cycle 1 Day 1 (each cycle of 28 days) up to 27.3 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Other Adverse Events (AEs): Non-IRRs', 'timeFrame': 'From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Duration of Infusion Time for Pre-amivantamab Infusion Medications, IV Amivantamab Infusion, and Post-amivantamab Infusion Medications on Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (each cycle of 28 days)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Completing Amivantamab Infusion Within 4 Hours on Cycle 1 Day 1', 'timeFrame': 'Up to 4 hours on Cycle 1 Day 1 (each cycle of 28 days)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'timeFrame': 'From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'timeFrame': 'From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-07'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A: Dexamethasone 4 Milligrams (mg)', 'description': 'Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than \\[\\<\\] 80 kilograms \\[kg\\]) or 1400 mg (for participants greater than or equal to \\[\\>=\\] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}, {'id': 'FG001', 'title': 'Cohort A2: Dexamethasone 8 mg', 'description': 'Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}, {'id': 'FG002', 'title': 'Cohort B: Montelukast 10 mg', 'description': 'Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}, {'id': 'FG003', 'title': 'Cohort C: Methotrexate 25 mg', 'description': 'Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A: Dexamethasone 4 Milligrams (mg)', 'description': 'Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than \\[\\<\\] 80 kilograms \\[kg\\]) or 1400 mg (for participants greater than or equal to \\[\\>=\\] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}, {'id': 'BG001', 'title': 'Cohort A2: Dexamethasone 8 mg', 'description': 'Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}, {'id': 'BG002', 'title': 'Cohort B: Montelukast 10 mg', 'description': 'Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}, {'id': 'BG003', 'title': 'Cohort C: Methotrexate 25 mg', 'description': 'Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \\<80 kg) or 1400 mg (for participants \\>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '13.60', 'groupId': 'BG000'}, {'value': '62.0', 'spread': '9.68', 'groupId': 'BG001'}, {'value': '65.0', 'spread': '8.72', 'groupId': 'BG002'}, {'value': '66.2', 'spread': '11.96', 'groupId': 'BG003'}, {'value': '62.7', 'spread': '10.04', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '42', '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': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-21', 'size': 2587390, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-03T09:37', 'hasProtocol': True}, {'date': '2024-06-14', 'size': 2079560, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-03T09:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'dispFirstSubmitDate': '2025-03-27', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2022-12-16', 'resultsFirstSubmitDate': '2025-10-03', 'studyFirstSubmitQcDate': '2022-12-16', 'dispFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-03', 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (each cycle of 28 days)', 'description': 'Percentage of participants with IRRs at Cycle 1 Day 1 was reported. IRRs were defined as IRR events with onset time within 24 hours of the start of the first amivantamab infusion and prior to the start of amivantamab infusion on Cycle 1 Day 2. IRR included chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever. IRRs that occurred on Cycle 1 Day 2 pre-infusion were considered under Cycle 1 Day 1.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events of Infusion-related Reactions (IRRs) During Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (each cycle of 28 days)'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) of Infusion-related Reactions (IRRs) as Per Severity up to End of Cycle 3 (Cycle 3 Day 28)', 'timeFrame': 'From Cycle 1 Day 1 up to Cycle 3 Day 28 (each cycle of 28 days)'}, {'measure': 'Percentage of Participants With IRRs up to End of Treatment (EOT)', 'timeFrame': 'From Cycle 1 Day 1 (each cycle of 28 days) up to 27.3 months'}, {'measure': 'Percentage of Participants With Other Adverse Events (AEs): Non-IRRs', 'timeFrame': 'From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months'}, {'measure': 'Duration of Infusion Time for Pre-amivantamab Infusion Medications, IV Amivantamab Infusion, and Post-amivantamab Infusion Medications on Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1 (each cycle of 28 days)'}, {'measure': 'Percentage of Participants Completing Amivantamab Infusion Within 4 Hours on Cycle 1 Day 1', 'timeFrame': 'Up to 4 hours on Cycle 1 Day 1 (each cycle of 28 days)'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to separately assess the potential of dexamethasone, montelukast and methotrexate administration, prior to amivantamab infusion given through a needle in the vein, to decrease the incidence and/or severity of first-dose infusion related reactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must have advanced or metastatic non-small cell lung cancer (NSCLC)\n* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1\n* A female participant using oral contraceptives must use an additional barrier contraceptive method\n* A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 3 months after receiving the last dose of study treatment, oral lazertinib and intravenous (IV) Amivantamab\n* Each participant, or legally authorized representative, where allowed, must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study\n* Progressed on or after prior treatment with osimertinib and platinum-based chemotherapy. Prior use of first-or-second generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) is allowed if administered prior to osimertinib\n* Previously identified EGFR-mutated non-small cell lung cancer (NSCLC) (EGFR Exon19 deletion or L858R) (identified locally in a Clinical Laboratory Improvement Amendments \\[CLIA\\]-certified laboratory \\[or equivalent\\])\n\nExclusion Criteria:\n\n* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis\n* Prior treatment with anti PD-1 or anti PD-L1 antibody within 6 weeks of planned first dose of study treatment or immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment\n* Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment are allowed. If brain metastases are diagnosed on Screening imaging, the participant may be enrolled, or rescreened for eligibility, after definitive treatment if above criteria are met\n* Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade 1 or baseline level (except for alopecia \\[any grade\\], Grade less than or equal to \\[\\<=\\] 2 peripheral neuropathy, and Grade \\<=2 hypothyroidism stable on hormone replacement therapy)\n* Prior treatment with amivantamab or lazertinib'}, 'identificationModule': {'nctId': 'NCT05663866', 'briefTitle': 'Premedication to Reduce Amivantamab Associated Infusion Related Reactions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; 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