OncoMatch/Clinical Trials/NCT06863506
Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC
Is NCT06863506 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
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.
Frequently asked questions
Is NCT06863506 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior egfr tyrosine kinase inhibitor disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR exon 20 insertion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR g719x is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR l861q is a required biomarker for enrollment.
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 qualifyRelated pages