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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Befotertinib will be administered orally at an initial dose of 75 mg once daily for 21 days, with escalation to 100 mg if tolerated. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGObjective response rate (ORR) assessed by RECIST 1.1.
Time frame: From enrollment until treatment discontinuation (up to 24 months)
progression-free survival (PFS)
Time frame: From first dose to disease progression or death (assessed up to 36 months)
Disease control rate (DCR)
Time frame: From enrollment until treatment discontinuation (up to 24 months)
duration of response (DoR)
Time frame: From the first documented response to disease progression or death, whichever occurs first, assessed up to 36 months.
overall survival（OS）
Time frame: From enrollment until death from any cause, assessed up to 60 months. Survivors will be censored at the last follow-up
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