Actively Recruiting
Chemoimmunotherapy Plus Radiotherapy for Extensive Stage Small-cell Lung Cancer
Led by Qingdao Central Hospital · Updated on 2024-07-23
70
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of combining chemotherapy, immunotherapy, and targeted radiation on patients with extensive stage small cell lung cancer, a condition known for initial sensitivity to treatment but eventual resistance. The study aims to assess how adding radiation to residual tumor areas after chemoimmunotherapy affects progression-free survival and overall survival. This phase II trial also monitors the treatment's response rate and potential side effects. Participants receive a combination of carboplatin, adebrelimab, and etoposide intravenously in cycles every 28 days, up to four cycles if there is no disease progression or unacceptable toxicity. Following chemotherapy and immunotherapy, residual tumors are treated with external beam radiation totaling 50 Gy delivered in 25 fractions. This sequential approach aims to address remaining tumor cells and possibly extend drug resistance. During the study, patients undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, blood tests for counts and organ function, and monitoring for adverse effects. Researchers track progression-free survival over 24 months and overall survival over 36 months. Participation involves scheduled treatments and evaluations to measure how well the combined therapy controls the cancer and its safety profile, with the study continuing until March 2027.
CONDITIONS
Brief Title
Chemoimmunotherapy Plus Residual Lesion Irradiation for the Treatment of Extensive Stage Small-cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less at treatment start
- Histologically or cytologically confirmed diagnosis of small cell lung cancer
- Extensive stage disease with malignant pleural effusion, contralateral lung metastases, or extra-thoracic metastases
- Measurable disease based on RECIST 1.1 criteria before chemotherapy
- Absolute neutrophil count (ANC) of at least 1.5 x 10^9/L
- Platelet count of at least 100 x 10^9/L
- Hemoglobin level of at least 9 g/dL
- Serum creatinine at or below 1.5 times the institution's upper limit of normal and creatinine clearance of at least 15 ml/min
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no more than 3 times upper limit of normal (up to 5 times if liver metastases present)
- Total serum bilirubin no more than 1.5 times upper limit of normal (up to 3 times if Gilbert's syndrome with normal direct bilirubin)
- Able to understand investigational nature and sign informed consent
You will not qualify if you...
- Major surgery within 14 days before starting study drug or not recovered from major surgery side effects (tumor biopsy excluded)
- Positive for immunosuppressive diseases such as AIDS or other immune depressing conditions
- Known hypersensitivity to study drug components or similar drugs
- History or current condition that could interfere with study participation or safety, including myocardial infarction or thromboembolic events within 6 months, severe or unstable angina, NYHA class III or IV heart failure, or poorly controlled arrhythmias
- Positive testing for HIV, hepatitis B or C required before enrollment
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 4 months
Participants receive combined chemotherapy and immunotherapy every 28 days for up to 4 cycles, followed by external beam irradiation to residual lung tumors given in 25 fractions totaling 50 Gy.
Up to 4 treatment cycles every 28 days and daily radiation sessions for residual tumor irradiation
Duration - Up to 36 months
Participants are observed to assess progression-free survival and overall survival after treatment completion.
Periodic follow-up visits as scheduled by the study
Trial Site Locations
Total: 3 locations
1
Qingdao Central Hospital
Qingdao, Shandong, China, 266042
Actively Recruiting
2
Qingdao Central Hospital
Qingdao, Shandong, China, 266042
Actively Recruiting
3
Qingdao Central Hospital
Qingdao, Shandong, China, 266042
Actively Recruiting
Research Team
C
chunling zhang, md
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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