Actively Recruiting
A Prospective Study of Befotertinib Adjuvant Therapy in Patients With Postoperative MRD-positive Non-small Cell Lung Cancer in Stage IA2-IB With High Risk Factors
Led by Fudan University · Updated on 2024-08-22
592
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating 3-year disease-free survival in patients with early-stage non-small cell lung cancer (NSCLC) who have minimal residual disease (MRD) positive for EGFR-sensitive mutations after surgery. The study compares the outcomes of patients treated with adjuvant befortinib, an oral third-generation epidermal growth factor receptor tyrosine-kinase inhibitor, against those under routine observation. This prospective trial focuses on patients with high-risk factors following complete tumor removal in stages IA2 to IB NSCLC. Participants receive befortinib as an adjuvant therapy after surgery, or they are monitored under routine observation without additional treatment. The study includes patients who have undergone R0 resection with specific tumor sizes and confirmed EGFR mutations, along with at least two high-risk pathological features. Treatment details include oral befortinib administration during the adjuvant period, with follow-up to assess disease progression. During the study, participants undergo MRD screening and regular follow-up visits to monitor their health status and disease-free survival over three years. Researchers assess outcomes such as disease recurrence and survival rates, alongside safety and organ function tests. Participants must comply with scheduled evaluations and provide informed consent, with the study duration extending up to three years to evaluate long-term disease-free outcomes.
CONDITIONS
Brief 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) resection
- Tumor size between 1 and 4 cm confirmed as stage IA2-IB
- Surgical tissue positive for EGFR-sensitive mutations and minimal residual disease (MRD) after surgery
- Presence of at least two high-risk factors such as pleural invasion, airway diffusion, vascular infiltration, low differentiation, or specific pathological features
- R0 resection achieved with appropriate lymph node biopsies or dissection
- ECOG performance status score of 0 to 1 and expected survival over 1 year
- Voluntary MRD screening and willingness to undergo befortinib adjuvant therapy
- Adequate organ function including specified blood counts and liver and kidney tests
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for 3 months after treatment
- Male participants with partners of childbearing potential must be surgically sterilized or use contraception during and for 3 months after treatment
- Ability and willingness to follow study and follow-up procedures
- Signed informed consent form
You will not qualify if you...
- Received any treatment before surgery without informed consent
- Diagnosis of any other cancer within the past 2 years
- History of interstitial lung disease or active interstitial lung disease confirmed by clinical evidence or CT scan
- Known allergy to befortinib or similar drugs
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable for participation by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive Befotertinib, a selective oral drug, as adjuvant therapy after surgery for non-small cell lung cancer with specific risk factors.
Regular visits during treatment as per protocol
Trial Site Locations
Total: 1 location
1
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
H
Hang Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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