Phase 2 Study Comparing Osimertinib Alone or With Chemotherapy for Metastatic EGFR-Mutant Lung Cancer

What this Trial Is About

Researchers are evaluating the effectiveness of osimertinib alone compared to osimertinib combined with chemotherapy carboplatin and pemetrexed in people with metastatic lung cancer that has a mutation in the EGFR gene. Osimertinib alone is the current standard treatment for this type of lung cancer, but adding chemotherapy may improve anticancer effects and help prevent the disease from growing or spreading. This is a Phase 2 randomized study focused on patients with persistent EGFR mutations detected in plasma after starting osimertinib treatment. Participants first receive osimertinib at a standard dose of 80mg orally once daily during a screening phase consisting of three 21-day cycles. Patients with persistent EGFR mutations in their plasma after this initial period are then randomly assigned to continue osimertinib alone or to receive osimertinib combined with carboplatin and pemetrexed chemotherapy. Chemotherapy is given intravenously every 3 weeks for four cycles, followed by maintenance pemetrexed. Participants in both groups track medication use with a pill diary starting at cycle 4. During the study, participants will be monitored regularly through clinical assessments, blood tests, and imaging to evaluate tumor response and overall health. Researchers will measure progression-free survival over two years as the primary outcome, along with overall response rate. The study includes careful monitoring of organ function and side effects, and participants are followed until study completion in 2027. This trial is sponsored by Memorial Sloan Kettering Cancer Center and aims to assess whether adding chemotherapy to osimertinib offers additional benefits for lung cancer patients.

Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers