Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC
Recruiting
Phase 2
Interventional Study
NSCLC (Non-small Cell Lung Cancer)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 78 (estimated)
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
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About This Trial
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, L…
Trial Locations
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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-bas…
Contacts