OncoMatch/Clinical Trials/NCT06863506
Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC
Is NCT06863506 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies befotertinib for nsclc (non-small cell lung cancer).
Treatment: befotertinib — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 20 insertion
Required: EGFR g719x
Required: EGFR l861q
Required: EGFR s768i
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy
Cannot have received: egfr tyrosine kinase inhibitor
Lab requirements
Cardiac function
Severe cardiovascular disease (e.g., QTc ≥450 ms, myocardial infarction within 6 months) [excluded]
Severe cardiovascular disease (e.g., QTc ≥450 ms, myocardial infarction within 6 months) [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify