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

NCT06863506 | Recruiting Phase 2

• 1 other identifier: 2024-0190
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) assessed by RECIST 1.1.

  From enrollment until treatment discontinuation (up to 24 months)

Secondary Outcomes (4)

• progression-free survival (PFS)

  From first dose to disease progression or death (assessed up to 36 months)

• Disease control rate (DCR)

  From enrollment until treatment discontinuation (up to 24 months)

• duration of response (DoR)

  From the first documented response to disease progression or death, whichever occurs first, assessed up to 36 months.

• overall survival（OS）

  From enrollment until death from any cause, assessed up to 60 months. Survivors will be censored at the last follow-up

Study Arms (2)

G719X, L861Q, or S768I)

EXPERIMENTAL

Patients with EGFR uncommon mutations (G719X, L861Q, or S768I)

Drug: befotertinib

exon 20 insertion

EXPERIMENTAL

Patients with EGFR exon 20 insertion mutations

Drug: befotertinib

Interventions

befotertinib DRUG

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.

G719X, L861Q, or S768I); exon 20 insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital: collaborator
• Hunan Cancer Hospital - the Affiliated Cancer Hospital of Xiangya school of Medicine, Central South University: collaborator
• Taizhou Hospital: collaborator
• West China Hospital: collaborator

Study Sites (1)

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Li Wen, Prof.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Xia Yang, Prof.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia Yang

CONTACT

+86 18868439669; yxia@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 7, 2025

Record last verified: 2025-02

Locations

CN (1)