Actively Recruiting
Neoadjuvant Befotertinib Combined with Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer: A Randomized Controlled Trial
Led by Peng Zhang · Updated on 2025-01-06
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with resectable stage II to IIIA non-small cell lung cancer (NSCLC) who have an EGFR mutation. The trial compares neoadjuvant therapies combining befotertinib with either bevacizumab or platinum-based double chemotherapy. This phase 2, randomized controlled trial aims to understand how these combinations affect tumor response before surgery. Participants will receive one of two study treatments: befotertinib combined with bevacizumab or befotertinib combined with platinum-based double chemotherapy. These treatments are given prior to surgery to shrink tumors and allow for radical surgery. The study is designed to assess major pathologic response up to 4 months after treatment and includes follow-up for longer-term outcomes. During the study, participants will undergo regular assessments including imaging scans (CT, PET-CT, MRI), tumor measurements, and laboratory tests to monitor tumor response and organ function. Researchers will track outcomes such as objective response rate, progression-free survival, disease-free survival, overall survival, and adverse events over up to 60 months. The trial involves signing informed consent and requires good lung function to tolerate surgery, with safety monitoring throughout the study period.
CONDITIONS
Brief Title
Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- NSCLC patient with EGFR sensitive mutation confirmed by needle biopsy
- Stage II-IIIA according to TNM Staging Version 8 identified by chest CT, PET-CT, or EBUS
- No systemic metastasis confirmed by brain MRI, bone scan, PET-CT, liver and adrenal CT
- Feasibility to receive radical surgery
- Good lung function to tolerate surgery
- Aged 18 to 75 years
- At least one measurable tumor focus with longest diameter over 10 mm by CT
- Major organs functioning well, including liver, kidney, and blood system
- ECOG performance status score of 0 to 1
- Child-bearing female must have negative pregnancy test within 7 days before treatment and use reliable contraception during and 30 days after trial
- Child-bearing male must use condoms during and 30 days after trial
- Patient must sign informed consent form
You will not qualify if you...
- Previous systemic anti-cancer treatment for NSCLC, including surgery, radiotherapy, chemotherapy, targeted therapy, or experimental treatment
- Unstable systemic diseases such as active infection, uncontrolled hypertension, recent angina, congestive heart failure (NYHA Grade II or higher), recent cardiac infarction, severe arrhythmia, or liver, kidney, or metabolic diseases requiring treatment
- HIV carrier
- History or current interstitial lung disease
- Major systemic operations or severe trauma within 3 months before trial
- Allergy to befotertinib or its excipients
- Allergy to bevacizumab or its excipients
- Allergy to platinum-based double chemotherapy or its excipients
- Pregnancy or lactation
- Any condition making the patient unsuitable for enrollment as judged by the investigator
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 4 months
Participants receive neoadjuvant treatment with Befotertinib combined with either Bevacizumab or platinum-based double chemotherapy prior to surgery.
Visits scheduled as per treatment cycles (exact frequency may vary)
Duration - Up to 60 months
Participants are monitored for progression-free, event-free, disease-free, and overall survival following treatment.
Periodic visits for monitoring up to 5 years
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
P
Peng Zhang
Y
Yue Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here