drugset / Trial / NCT06863506
Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC
Phase 2
Recruiting
78 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hunan Cancer Hospital - the Affiliated Cancer Hospital of Xiangya school of Medicine, Central South University · collabTaizhou Hospital · collabWest China Hospital · collabZhengzhou University · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, multi-cohort, single-arm Phase II clinical trial evaluating the efficacy and safety of befotertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR non-classical mutations. The study comprises two independent cohorts: Cohort 1: Patients with EGFR uncommon mutations (G719X, L861Q, or S768I). Cohort 2: Patients with EGFR exon 20 insertion mutation Primary endpoint: Objective response rate (ORR) assessed by RECIST 1.1. Secondary endpoints: Disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety profile (CTCAE v4.03).
Timeline
- Start
- 2024-10-01
- Primary completion
- 2027-06-30
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Befotertinib | Small molecule | 100 mg | Oral |