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

March 3, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G719X, L861Q, or S768I)
Patients with EGFR uncommon mutations (G719X, L861Q, or S768I)
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.
Experimental: exon 20 insertion
Patients with EGFR exon 20 insertion mutations
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR) assessed by RECIST 1.1.
Time Frame: From enrollment until treatment discontinuation (up to 24 months)
From enrollment until treatment discontinuation (up to 24 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival (PFS)
Time Frame: From first dose to disease progression or death (assessed up to 36 months)
From first dose to disease progression or death (assessed up to 36 months)
Disease control rate (DCR)
Time Frame: From enrollment until treatment discontinuation (up to 24 months)
From enrollment until treatment discontinuation (up to 24 months)
duration of response (DoR)
Time Frame: From the first documented response to disease progression or death, whichever occurs first, assessed up to 36 months.
From the first documented response to disease progression or death, whichever occurs first, assessed up to 36 months.
overall survival（OS）
Time Frame: From enrollment until death from any cause, assessed up to 60 months. Survivors will be censored at the last follow-up
From enrollment until death from any cause, assessed up to 60 months. Survivors will be censored at the last follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

West China Hospital
Taizhou Hospital
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Hunan Cancer Hospital - the Affiliated Cancer Hospital of Xiangya school of Medicine, Central South University

Investigators

  • Principal Investigator: Li Wen, Prof., Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Principal Investigator: Xia Yang, Prof., Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0190

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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