Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC

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).

Eligibility

Inclusion Criteria:

* Age ≥18 years, ECOG performance status 0-2
* Histologically confirmed locally advanced/metastatic NSCLC
* Documented EGFR mutations: Cohort 1 (G719X/L861Q/S768I) or Cohort 2 (exon 20 insertion)
* No prior EGFR-TKI therapy
* Progression or intolerance to ≥1 line of platinum-based chemotherapy -≥1 measurable lesion per RECIST 1.1

Exclusion Criteria:

* Previous EGFR-TKI treatment
* Active CNS metastases (asymptomatic patients with stable lesions allowed)
* Severe cardiovascular disease (e.g., QTc ≥450 ms, myocardial infarction within 6 months)
* Active HBV/HCV/HIV infection
* Pregnancy or lactation

Conditions3

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