Actively Recruiting
Adebrelimab with Chemotherapy, with or without Bevacizumab, as Neoadjuvant Therapy for Resectable Non-Squamous Non-Small Cell Lung Cancer A Randomized Phase II Study Evaluating Treatment Before Surgery
Led by The First Affiliated Hospital of Guangzhou Medical University · Updated on 2025-01-15
60
Participants Needed
1
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase II, prospective, multicenter, randomized study to evaluate the effectiveness and safety of adebrelimab combined with chemotherapy, with or without bevacizumab, as a neoadjuvant treatment for patients with resectable Stage II-IIIB (T3N2) non-squamous non-small cell lung cancer (NSQ-NSCLC). The study also aims to explore biomarkers related to treatment efficacy. Patients included have treatment-naive NSQ-NSCLC and meet specific health criteria for surgery suitability. The study involves neoadjuvant therapy where patients receive adebrelimab along with platinum-based chemotherapy drugs such as paclitaxel, albuminotaxol, docetaxel, or pemetrexed combined with carboplatin, cisplatin, or nedaplatin. Some patients also receive bevacizumab. Treatment is given in cycles before surgical removal of the tumor. Surgery is scheduled 4 to 6 weeks after completing four cycles of neoadjuvant therapy, with each cycle lasting 3 weeks. Participants will be closely monitored through surgical pathology to assess the pathological complete response within one week of surgery. The study includes evaluations of safety and effectiveness throughout the treatment and post-surgery period. The total age range for participants is 18 to 65 years, and both males and females are eligible to participate.
CONDITIONS
Official Title
A Study of Adebrelimab in Combination with Chemo with or Without Bevacizumab Neoadjuvant Therapy for Resectable NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Resectable non-squamous non-small cell lung cancer
- Age between 18 and 65 years
- Male or female
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No prior surgery, chemotherapy, radiotherapy, or biological treatment for non-squamous non-small cell lung cancer
- Adequate lung function for planned lung surgery
You will not qualify if you...
- Small cell lung cancer or squamous non-small cell lung cancer
- Previous treatment with anti-PD1, anti-PDL1, anti-CTLA4 antibodies, or similar drugs
- Prior use of anti-angiogenic drugs
- Allergy to any component of the study drugs or chemotherapy
- Presence of any severe or uncontrolled medical condition
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Trial Site Locations
Total: 1 location
1
Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Actively Recruiting
Research Team
J
Jianxing He
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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