Actively Recruiting
Befotertinib Adjuvant Therapy in Stage IA2-IB NSCLC Patients
Led by Fudan University · Updated on 2024-08-22
592
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate 3-year disease-free survival after complete resection in patients with MRD-positive EGFR-sensitive mutations in Stage IA2-IB NSCLC treated with adjuvant befortinib and under routine observation (3y-DFS).
CONDITIONS
Official Title
Befotertinib Adjuvant Therapy in Stage IA2-IB NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Both men and women are eligible
- Lung adenocarcinoma patients who underwent complete (R0) tumor removal and are clinically confirmed as stage IA2-IB with tumor size 1-4 cm
- Surgical tissue positive for EGFR-sensitive mutations and positive for minimal residual disease after surgery
- Presence of at least 2 high-risk factors such as pleural invasion, airway diffusion, vascular infiltration, low differentiation, micropapillary composition ≥ 15%, or complex glandular composition ≥ 20%
- Achieved R0 resection with appropriate lymph node biopsies or dissection based on tumor type
- ECOG performance status score of 0 or 1 with expected survival over 1 year
- Voluntary MRD screening and willingness to receive befortinib adjuvant therapy
- Adequate organ function defined by blood counts, liver enzymes, and kidney function
- Female subjects of childbearing age must have a negative pregnancy test within 3 days before starting the study drug and agree to use effective contraception during and 3 months after treatment
- Willing and able to comply with study procedures and follow-up
- Signed informed consent form
You will not qualify if you...
- Received any treatment before surgery or did not sign informed consent
- Diagnosed with any cancer within the past 2 years
- History of interstitial lung disease, drug-induced lung disease, or active interstitial lung disease on baseline CT
- Known allergy to befortinib or similar drugs
- Pregnant or breastfeeding women
- Any other conditions deemed unsuitable for participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
H
Hang Li
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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