Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: befotertinib.
- Who it may be relevant to
- Registry conditions: NSCLC (Non-small Cell Lung Cancer). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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).
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.
Primary outcome measures
- Objective response rate (ORR) assessed by RECIST 1.1. [Time frame: From enrollment until treatment discontinuation (up to 24 months)]
Secondary outcome measures (4)
- progression-free survival (PFS) [Time frame: 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)]
- duration of response (DoR) [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- 2nd Affiliated Hospital, School of Medicine — Hangzhou
Identifiers
NCT: NCT06863506 · 2024-0190