Evaluating befotertinib for advanced non-small cell lung cancer with specific EGFR mutations
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
This study is testing a new drug called befotertinib to see if it can help people with advanced lung cancer who have specific types of EGFR mutations after other treatments haven't worked.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, befotertinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06863506 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial investigates the efficacy and safety of befotertinib, a third-generation EGFR tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that have non-classical EGFR mutations. The trial consists of two cohorts: one for patients with uncommon EGFR mutations (G719X, L861Q, or S768I) and another for those with EGFR exon 20 insertion mutations. The primary endpoint is the objective response rate, while secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety profile. Participants must have progressed on or been intolerant to prior platinum-based chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic NSCLC harboring specific EGFR mutations and who have not previously received EGFR-TKI therapy.
Not a fit: Patients with active CNS metastases, severe cardiovascular disease, or those who have previously received EGFR-TKI treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with specific EGFR mutations in NSCLC who currently have limited treatment choices.
How similar studies have performed: Other studies have shown promising results with similar approaches targeting EGFR mutations, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Li Wen, Prof. — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Xia Yang
- Email: yxia@zju.edu.cn
- Phone: +86 18868439669
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.