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

NCT06863506 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-03-07

No results posted yet for this 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).

Conditions

  • NSCLC (Non-small Cell Lung Cancer)

Interventions

DRUG

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.

Sponsors & Collaborators

  • The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

    collaborator UNKNOWN

  • Hunan Cancer Hospital - the Affiliated Cancer Hospital of Xiangya school of Medicine, Central South University

    collaborator UNKNOWN

  • Taizhou Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Li Wen, Prof. · Second Affiliated Hospital, School of Medicine, Zhejiang University

  • Xia Yang, Prof. · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2027-06-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06863506 on ClinicalTrials.gov