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

Recruiting now · Phase 2

Conditions studied: NSCLC (Non-small Cell Lung Cancer)

In brief

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).

Key facts

Study ID

NCT06863506

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

78

Starts

2024-10-01

Expected to finish

2027-12-30

Last updated by the study team

2025-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 2nd Affiliated Hospital, School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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