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Study identifier: NCT06863506 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC

Condition: NSCLC (Non-small Cell Lung Cancer)  ·  Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

PhasePhase 2
Planned participants78
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Xia Yang  ·  +86 18868439669  ·  yxia@zju.edu.cn

Always discuss trial participation with your own doctor first.

Locations (1)

2nd Affiliated Hospital, School of MedicineHangzhou, Zhejiang, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06863506