Trial Identifiers
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Scientific Title
A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Commercial Sponsor
Janssen-Cilag Pty Ltd
Summary
Eligible participants will be randomised to receive Pemetrexed and Carboplatin (chemotherapy) alone or in addition to Amivantamab. In Arm A and B, participants will receive 500 milligram per meter square (mg/m^2) intravenous (IV) pemetrexed on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. In addition to receiving chemotherapy treatment, participants in Arm A will also receive 1400mg IV amivantamab once weekly up to Cycle 2 Day 1, then 1750 mg IV amivantamab on Day 1 of each 21-day cycle, starting with Cycle 3. Participants in Arm B will receive chemotherapy alone.