Actively Recruiting
Neoadjuvant Adebrelimab Combined With Chemotherapy for Resectable Small Cell Lung Cancer: A Multicenter Randomized Controlled Trial
Led by Tang-Du Hospital · Updated on 2024-07-03
104
Participants Needed
1
Research Sites
52 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 as a neoadjuvant treatment for patients with resectable stage I to IIIB small cell lung cancer (SCLC), with stage IIIB limited to specific tumor and lymph node involvement. This randomized, open-label, multicenter Phase 2 trial aims to compare Adebrelimab plus chemotherapy against chemotherapy alone. The primary goal is to measure pathological complete response, while secondary goals include event-free survival, major pathological response, objective response rate, disease-free survival, and safety profiles. Participants are randomly assigned to one of two groups: one receives Adebrelimab together with Etoposide and a platinum-based drug (Cisplatin or Carboplatin), and the other receives only Etoposide and platinum-based chemotherapy. Adebrelimab is given intravenously at a fixed dose on the first day of each 3-week cycle, followed by chemotherapy over three days. Each patient undergoes 3 to 4 treatment cycles before a 4 to 6 week break leading up to surgery for tumor removal. Treatment may be stopped early if disease worsens, side effects are intolerable, consent is withdrawn, or other specified reasons occur. During the study, patients will have assessments including scans and laboratory tests to confirm eligibility and monitor response and safety. Researchers will evaluate tumor response before surgery and pathological outcomes shortly after surgery. Participants will be followed for at least two years to assess long-term survival and disease progression. Safety monitoring continues throughout the treatment and follow-up periods to ensure participant well-being.
CONDITIONS
Brief Title
Neoadjuvant Adebrelimab in Resectable SCLC: A Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, inclusive, with no gender restriction
- ECOG performance status of 0-1
- Confirmed diagnosis of small cell lung cancer (SCLC) by histology or cytology
- Resectable or potentially resectable stage I-IIIB (T1-4N0-2M0) SCLC per 8th AJCC staging
- Measurable tumor lesions by CT scan (tumor long axis ≥10 mm or lymph node short axis ≥10 mm)
- No prior treatment for SCLC including radiation, chemotherapy, traditional Chinese medicine, surgery, or targeted therapy
- Imaging (PET-CT, enhanced CT or ultrasound of chest/abdomen, brain MRI, bone scan) showing no metastatic lesions
- Sufficient cardiopulmonary function to tolerate lung surgery
- No contraindications to immune checkpoint inhibitors based on lab tests
- Normal organ function including blood counts, liver and kidney function, and coagulation within specified limits
- Female participants of childbearing potential must have negative pregnancy test and agree to effective contraception during and 3 months after treatment
- Male participants with partners of childbearing potential must agree to effective contraception during and 3 months after treatment
- Voluntary informed consent with good compliance and agreement to follow-up visits
You will not qualify if you...
- Central nervous system metastasis
- Active autoimmune diseases or history of moderate to severe autoimmune conditions (except certain controlled or resolved conditions)
- Immunodeficiency conditions such as HIV, active hepatitis B or C, or active tuberculosis
- Use of immunosuppressive drugs within 14 days before first study drug (except certain corticosteroids)
- Live attenuated vaccine within 4 weeks before first study drug or planned during study
- Any other cancer diagnosis within past 3 years
- Past or current severe lung diseases including pulmonary fibrosis or impaired lung function
- Uncontrolled high blood pressure
- Significant heart conditions including recent myocardial infarction, heart failure, uncontrolled arrhythmias, or abnormal heart function
- Severe infection requiring systemic treatment or unexplained fever above 38.5°C within 4 weeks before first treatment
- History of allogeneic organ or stem cell transplantation
- Pregnant or breastfeeding women or unwilling/unable to use contraception
- Known allergies or intolerance to study drugs or their components
- Participation in another clinical trial within 4 weeks or less than 5 half-lives of previous study drug
- History of substance, alcohol, or drug abuse
- Any condition that may affect participant safety or study compliance as judged by 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 - 9 to 12 weeks
Participants receive neoadjuvant treatment with either Adebrelimab combined with Etoposide and Platinum-based therapy or Etoposide and Platinum-based therapy alone. Treatment consists of 3 to 4 cycles with each cycle lasting 3 weeks.
3 to 4 cycles with visits on Days 1 to 3 of each cycle
Duration - 4 to 6 weeks
Participants have a 4 to 6 week drug-free interval before undergoing surgical treatment.
No specific visits scheduled
Duration - 1 day
Participants undergo surgical treatment for resectable small cell lung cancer after completing neoadjuvant therapy.
1 surgical visit
Duration - At least 2 years
Participants are followed up long-term to monitor event-free survival, disease-free survival, recurrence, and overall health for at least two years after surgery.
Regular follow-up visits for monitoring
Trial Site Locations
Total: 1 location
1
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, China, 710038
Actively Recruiting
Research Team
X
Xiaolong Yan, Dr
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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