Phase 12 Study of JIN-A02 Oral Treatment for Safety, Tolerability, and Anti-Tumor Effects in Adults With EGFR Mutant Advanced Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating JIN-A02, a fourth-generation EGFR-TKI oral medication, in people with advanced non-small cell lung cancer NSCLC that has specific EGFR mutations and has progressed after standard treatments. This Phase III open-label study focuses on assessing the safety, tolerability, pharmacokinetics, and anti-tumor activity of JIN-A02 in those who have previously received approved EGFR-TKI therapy andor platinum-based chemotherapy. The study includes multiple parts to explore dosing and treatment effects based on mutation types. The study has three parts Part A is a dose escalation phase using a Bayesian Optimal Interval design to find the maximum tolerated dose MTD in patients with EGFR mutations C797S or T790M. JIN-A02 is given once daily in 28-day cycles, with dose adjustments based on safety evaluations. Part B further explores two selected dose levels to determine the recommended Phase 2 dose RP2D. Part C expands treatment to five cohorts defined by specific EGFR mutation profiles, monitoring anti-tumor activity using the established RP2D. Participants undergo regular assessments including safety reviews by a committee, tumor mutation testing from tissue or plasma samples, and monitoring for adverse events and dose-limiting toxicities. The study measures outcomes such as maximum tolerated dose, adverse event rates, and dose-limiting toxicities over specified timeframes. The study duration and follow-up depend on the dose-escalation, exploration, and expansion phases with ongoing data collection for safety and benefit-risk analysis.

A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC