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NCT Number: NCT06863506

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

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).

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Key information

Conditions

NSCLC (Non-small Cell Lung Cancer) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Xia Yang

CONTACT

[email protected]

+86 18868439669

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: From enrollment until treatment discontinuation (up to 24 months)

Secondary outcomes

  1. progression-free survival (PFS)

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

  2. Disease control rate (DCR)

    Time frame: From enrollment until treatment discontinuation (up to 24 months)

  3. duration of response (DoR)

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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Xia Yang

CONTACT

[email protected]

+86 18868439669

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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