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

NCT06863506 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Phase 2

Started

2024-10-01

Last updated

2025-03-07

Condition(s) studied

NSCLC (Non-small Cell Lung Cancer)

Investigational drug(s) / intervention(s)

befotertinib

befotertinib: Befotertinib will be administered orally at an initial dose of 75 mg once daily for 21 days, with escalation to 100 mg if tolerated. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Objective response rate (ORR) assessed by RECIST 1.1. — From enrollment until treatment discontinuation (up to 24 months)

Trial sites (1)

Facility	City	Region	Status
2nd Affiliated Hospital, School of Medicine	Hangzhou	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06863506 on ClinicalTrials.gov ↗ ← All trials in China