Phase III Study Comparing Befotertinib and Icotinib as Post-Surgery Adjuvant Treatment for Stage IB-IIIB Non-Small Cell Lung Cancer with EGFR Sensitive Mutations

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Befotertinib compared with Icotinib as postoperative adjuvant treatments in adults with stage IB-IIIB non-small cell lung cancer that has EGFR-sensitive mutations. This Phase III, multicenter, randomized, controlled, double-blind study focuses on patients whose cancer has been surgically removed and aims to improve disease-free survival. The study is sponsored by Betta Pharmaceuticals Co., Ltd. and targets patients with specific EGFR mutations linked to treatment sensitivity. Participants are randomly assigned to receive either Befotertinib plus an Icotinib placebo or Icotinib plus a Befotertinib placebo. Befotertinib is taken orally once daily starting at 75 mg and increasing to 100 mg if tolerated, for up to three years or until disease recurrence or unacceptable side effects. Icotinib or its placebo is taken orally three times daily for up to two years under similar conditions. The double-simulated design ensures all participants take both a study drug and a placebo. Throughout the study, participants will attend scheduled visits for monitoring, including laboratory tests and safety assessments. Researchers will measure disease-free survival up to five years after treatment starts, focusing on cancer recurrence or progression. The study includes careful tracking of side effects and overall health, with follow-up extending to evaluate outcomes over a prolonged period. Participants must meet specific health and recovery criteria following surgery to join and remain in the trial.

Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations