Actively Recruiting
A Randomized Phase II Study of Adebrelimab with Chemotherapy with or Without Bevacizumab as Neoadjuvant Therapy for Resectable Non-Squamous Non-Small Cell Lung Cancer
Led by The First Affiliated Hospital of Guangzhou Medical University · Updated on 2025-01-15
60
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of adebrelimab combined with chemotherapy, with or without bevacizumab, as a neoadjuvant treatment for adults aged 18 to 65 with resectable Stage II-IIIB non-squamous non-small cell lung cancer (NSQ-NSCLC). This Phase II, randomized, multicenter study aims to explore biomarkers linked to treatment response in this patient group. The trial is sponsored by The First Affiliated Hospital of Guangzhou Medical University and focuses on treatment before surgery to improve outcomes. Participants will receive either a combination of adebrelimab, chemotherapy, and bevacizumab or adebrelimab with chemotherapy alone. The chemotherapy regimens include paclitaxel, albuminotaxol, or docetaxel combined with platinum agents such as carboplatin, cisplatin, or nedaplatin, or pemetrexed combined with platinum. Treatment cycles last three weeks each, with a total of four cycles prior to surgical tumor removal. Surgery is scheduled 4 to 6 weeks after completing neoadjuvant therapy. During the study, participants undergo pathological response assessments within one week after surgery to measure treatment effects. Researchers will also monitor overall response rates before surgery and track event-free survival for up to 24 months. Safety follow-up will occur 30 days after the last bevacizumab or chemotherapy dose or 90 days after the last adebrelimab dose or surgery, whichever is later, to record any adverse events. The total study participation involves treatment, surgery, monitoring, and follow-up evaluations.
CONDITIONS
Brief 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...
- Diagnosed with resectable non-squamous non-small cell lung cancer
- Aged 18 to 65 years
- Male or female
- ECOG performance status of 0 or 1
- Treatment-naive for surgery, chemotherapy, radiotherapy, and biological therapy
- Adequate lung function for planned pneumonectomy
You will not qualify if you...
- Diagnosis of small cell lung cancer or squamous non-small cell lung cancer
- Prior use of anti-PD1, anti-PDL1, or anti-CTLA4 antibodies
- Previous treatment with anti-angiogenic drugs
- Allergic to any component of study or chemotherapy drugs
- Presence of any severe or uncontrolled disease
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 - Approximately 12 weeks (4 cycles of 3 weeks each)
Participants receive neoadjuvant therapy consisting of 4 cycles of adebrelimab combined with chemotherapy, with or without bevacizumab, administered every 3 weeks.
4 treatment visits (in-person), one per cycle
Duration - Surgery and immediate recovery over 1 week
Participants undergo surgical resection of the tumor 4 to 6 weeks after completing neoadjuvant therapy.
1 surgery visit (in-person)
Duration - Approximately 1 to 3 months after surgery
Participants are monitored for safety and pathological response after surgery, including a safety follow-up visit 30 to 90 days after last treatment or surgery to track adverse events.
1 safety follow-up visit (in-person)
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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