Actively Recruiting
Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-03-07
78
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
Z
Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with ECOG performance status 0-2
- Histologically confirmed locally advanced or metastatic NSCLC
- Documented EGFR mutations: G719X, L861Q, S768I, or exon 20 insertion
- No prior treatment with EGFR tyrosine kinase inhibitors
- Disease progression or intolerance after at least one line of platinum-based chemotherapy
- At least one measurable lesion according to RECIST 1.1 criteria
You will not qualify if you...
- Previous treatment with EGFR tyrosine kinase inhibitors
- Active symptomatic central nervous system metastases (asymptomatic stable lesions allowed)
- Severe cardiovascular disease such as QTc interval ≥450 ms or recent myocardial infarction within 6 months
- Active hepatitis B, hepatitis C, or HIV infection
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xia Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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