Clinical trial · Interventional
Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC (Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| befotertinib | Drug | Befotertinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- G719X, L861Q, or S768I)
- description
- Patients with EGFR uncommon mutations (G719X, L861Q, or S768I)
- interventionNames
- Drug: befotertinib
- type
- EXPERIMENTAL
- label
- exon 20 insertion
- description
- Patients with EGFR exon 20 insertion mutations
- interventionNames
- Drug: befotertinib
Primary outcomes (1)
- measure
- Objective response rate (ORR) assessed by RECIST 1.1.
- timeFrame
- From enrollment until treatment discontinuation (up to 24 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available