Actively Recruiting
A Phase II Exploratory Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy as First-Line 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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 cycles
Participants receive Adebrelimab intravenously in combination with carboplatin or cisplatin and etoposide during this phase.
Multiple visits for drug administration across 2 cycles
Duration - 1 to 2 cycles
Participants receive thoracic radiation therapy and stereotactic body radiation therapy (SBRT) for metastases combined with carboplatin or cisplatin and etoposide chemotherapy for 1 to 2 cycles.
Visits for radiation therapy and chemotherapy sessions over 1 to 2 cycles
Duration - 1 to 2 cycles
Participants receive Adebrelimab combined with carboplatin or cisplatin and etoposide for 1 to 2 cycles following concurrent chemoradiotherapy.
Multiple visits for drug administration across 1 to 2 cycles
Duration - Until disease progression or withdrawal
Participants continue receiving Adebrelimab until persistent radiographic disease progression, intolerable toxicity, or withdrawal of consent.
Regular visits for Adebrelimab administration during maintenance
Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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