Phase 2 Open-Label Study of ABSK043 Combined With Firmonertinib for EGFR-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early anti-tumor activity of a combination of two drugs, ABSK043 and Firmonertinib, in patients with locally advanced or metastatic non-small cell lung cancer NSCLC that has a specific mutation in the EGFR gene. This Phase 2, open-label study focuses on patients with EGFR-mutated NSCLC and aims to find the best dose and schedule while closely monitoring patient safety. The study has two parts Part A is a dose escalation phase that includes patients who have previously received treatment and experienced disease progression Part B is a dose expansion phase involving patients who have not yet received systemic therapy for advanced disease. ABSK043 is given orally at either 400 mg or 800 mg twice daily, while Firmonertinib is given orally at a fixed dose of 80 mg once daily. Treatment cycles last 21 days, and patients continue therapy until disease progression, unacceptable side effects, withdrawal, or study end. Participants will undergo regular safety monitoring including assessments for dose-limiting toxicities, adverse events, serious adverse events, and specific side effects from the time they consent until up to 30 months after their last dose. Researchers will also measure progression-free survival at 12 months. Pharmacokinetic tests and tumor response evaluations are conducted during treatment. The total study duration per participant varies based on treatment response and safety outcomes.

A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib