RecruitingPhase 2NCT06863506

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

Prospective, Multi-cohort, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Befotertinib in EGFR-positive Non-classical Mutant Non-small Cell Lung Cancer Patients

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

78 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

NSCLC (Non-small Cell Lung Cancer)

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria5

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

Interventions

DRUGbefotertinib

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.