Phase III Study Comparing Furmonertinib Plus Platinum Chemotherapy Versus Osimertinib for Treating EGFR Mutation-Positive Non-Squamous NSCLC With Brain Metastases

What this Trial Is About

Researchers are conducting a Phase III, international, multicenter, randomized, controlled, open-label clinical trial to compare treatments for patients with non-squamous non-small cell lung cancer NSCLC who have brain metastases and specific EGFR mutations. The study aims to evaluate how well furmonertinib combined with platinum-based chemotherapy works compared to osimertinib alone, as well as to explore the effects of furmonertinib alone in some patients. This research focuses on treatments for this type of lung cancer with brain involvement, with safety and effectiveness as key concerns. The trial includes two main stages Stage 1 is a safety run-in phase enrolling about 30 subjects to test different doses of furmonertinib with platinum-based chemotherapy. Stage 2 is the randomized controlled phase, where approximately 350 subjects will be assigned to one of three groups furmonertinib plus platinum-based chemotherapy, osimertinib alone, or furmonertinib alone. Furmonertinib is taken orally daily in varying doses, while chemotherapy drugs like carboplatin, cisplatin, and pemetrexed are given by intravenous infusion every three weeks in cycles. Osimertinib is also taken orally daily. Treatment continues until unacceptable side effects, disease progression, death, or new anti-cancer therapy is started. Participants will undergo safety monitoring for adverse and serious adverse events for up to four years. Researchers will assess progression-free survival, response rates, disease control, overall survival, and patient-reported outcomes using questionnaires. Blood samples and other lab tests will measure drug levels and effects. The study also tracks tumor response using imaging and other evaluations. Participants are expected to attend regular visits for treatment, monitoring, and assessments throughout the study duration.

A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases