NSCLC (Non-small Cell Lung Cancer)
Conditions
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).
Interventions
DRUGbefotertinib
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
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
Taizhou Hospital
West China Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) assessed by RECIST 1.1. | From enrollment until treatment discontinuation (up to 24 months) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactXia Yang
Outcome results
None listed