NCT06863506 Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC
| NCT ID | NCT06863506 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | NSCLC (Non-small Cell Lung Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 78 participants in total. It began in 2024-10-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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
Contact & Investigator
Li Wen, Prof.
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT06863506 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC (Non-small Cell Lung Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06863506 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06863506 currently recruiting?
Yes, NCT06863506 is actively recruiting participants. Contact the research team at yxia@zju.edu.cn for enrollment information.
Where is the NCT06863506 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06863506 clinical trial?
NCT06863506 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Li Wen, Prof. at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 78 participants.
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