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

Brief description of study

The purpose of the study is to demonstrate the improved efficacy of combining amivantamab with standard of care carboplatin-pemetrexed chemotherapy compared with carboplatin-pemetrexed chemotherapy in the first-line treatment of patients with EGFR Exon 20ins non-small cell lung cancer (NSCLC). Amivantamab (JNJ-61186372) is a fully human IgG1-based bispecific Ab directed against the EGF and cMet receptors. The study drug amivantamab is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-00947
ClinicalTrials.gov Identifier: NCT04538664
Principal Investigator: Joshua K Sabari.


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