The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.
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
Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. Amivantamab (JNJ-61186372) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody directed against epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) tyrosine kinase receptors that is being developed for the treatment of solid tumors. The hypothesis is that amivantamab, when given in combination with standard of care carboplatin-pemetrexed chemotherapy, will prolong PFS compared with carboplatin-pemetrexed in patients with locally advanced or metastatic NSCLC characterized by EGFR Exon 20ins activating mutations. The study will include a Screening phase (28 days), a Treatment phase (from Cycle 1 Day 1 [21-day cycle] till end of treatment [30 days after last dose]) and a Follow up phase (from the end of treatment visit and until the end of study, death, loss to follow-up, or withdrawal of consent from participation in the study, whichever comes first). An independent data monitoring committee (IDMC) will be commissioned for the periodic review of safety and tolerability data, as well as planned efficacy analyses. Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis). The total duration of the study is up to 48 months.