Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Amivantamab: Amivantamab will be administered as an IV infusion once weekly up to Cycle 2 Day 1 and then 1 on Day 1 of each 21-day cycle starting with Cycle 3
Control Intervention1: Pem
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: - Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation - Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream - A female participant of childbearing potential must have a negative serum or urine 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
Exclusion criteria
Exclusion criteria: - Participant has evidence of synchronous NSCLC with an EGFR mutation other than EGFR Exon 20ins - Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible) - Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation - Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis - Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central ReviewTimepoint: Up to 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival After First Subsequent TherapyTimepoint: Up to 48 months;Serum Concentration of AmivantamabTimepoint: Up to 48 months;Time to Subsequent TherapyTimepoint: Up to 48 months;Time to Symptomatic ProgressionTimepoint: Up to 48 months;Duration of ResponseTimepoint: Up to 48 months;European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30Timepoint: Up to 48 months;Incidence and Severity of Adverse EventsTimepoint: Up to 48 months;Number of Participants with Anti-Amivantamab AntibodiesTimepoint: Up to 48 months;Number of Participants with Clinical Laboratory AbnormalitiesTimepoint: Up to 48 months;Number of Participants with Physical Examination AbnormalitiesTimepoint: Up to 48 months;Number of Participants with Vital Signs AbnormalitiesTimepoint: Up to 48 months;Objective Response RateTimepoint: Up to 48 months;Overall SurvivalTimepoint: Up to 48 months;Patient Reported Outcomes Measurement Information System-Physical FunctionTimepoint: Up to 48 months | — |
Countries
Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Poland, Portugal, Republic of Korea, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Sanish Davis
Janssen Pharmaceutical Companies of Johnson & Johnson
Outcome results
None listed