Actively Recruiting
Phase II Study of Adebrelimab With Chemotherapy and Radiotherapy as First Treatment for Extensive-Stage Oligometastatic Small Cell Lung Cancer
Led by Nanfang Hospital, Southern Medical University · Updated on 2023-12-20
62
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
N
Nanfang Hospital, Southern Medical University
Lead Sponsor
S
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Adebrelimab with carboplatin or cisplatin plus etoposide chemotherapy and concurrent radiotherapy as a first treatment for patients with extensive-stage oligometastatic small cell lung cancer. This Phase II open-label study aims to assess the safety and effectiveness of this regimen in this patient group. The trial is led by Nanfang Hospital, Southern Medical University and focuses on patients with limited metastatic lesions and organs affected. Participants will first receive Adebrelimab intravenously along with carboplatin or cisplatin and etoposide for two cycles during the induction phase. Next, participants undergo concurrent chemoradiotherapy, including thoracic radiation and stereotactic body radiation therapy SBRT to metastases, combined with one to two cycles of chemotherapy. Following this, they will receive one to two additional cycles of Adebrelimab combined with chemotherapy, and then continue on Adebrelimab alone as maintenance therapy until disease progression, unacceptable side effects, or withdrawal from the study. During the study, participants will be closely monitored through clinical assessments, imaging, and laboratory tests to track progression-free survival and other measures such as overall survival and response rates, with follow-up lasting up to approximately 30 months. Safety will be monitored by recording adverse events throughout the treatment and maintenance phases. The total participation time includes induction, concurrent chemoradiotherapy, maintenance, and follow-up periods to fully evaluate treatment outcomes and tolerability.
CONDITIONS
Brief Title
A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older and 75 years or younger
- Confirmed extensive-stage small cell lung cancer with 5 or fewer metastatic lesions and 3 or fewer metastatic organs
- No previous systemic chemotherapy, radiotherapy, or immune checkpoint inhibitor treatment
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Expected survival time of at least 3 months
- Submission of a pre-treatment tumor tissue sample
- Adequate blood and organ function
You will not qualify if you...
- Untreated or unstable spinal cord compression
- Leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Uncontrolled or symptomatic high calcium levels in the blood
- Other malignancies within 5 years prior to enrollment except those with very low risk of spread or death
- History of autoimmune diseases like myasthenia gravis, autoimmune hepatitis, lupus, rheumatoid arthritis, or inflammatory bowel disease
- Previous immune checkpoint inhibitor therapy
- Need for systemic corticosteroids above 10 mg prednisone equivalent or other immunosuppressive drugs within 14 days before treatment
- Significant heart disease
- History of bone marrow or solid organ transplant
- Use of systemic immunosuppressive medications within 1 week before enrollment
- History of severe allergic reactions to antibodies, carboplatin, or etoposide
- Any condition or treatment that might affect study results or participant safety as judged by the investigator
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