Status:
RECRUITING
A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Respiratory Tract Neoplasms
Thoracic Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin/Cisplatin plus (+) etoposide and concurrent radiotherapy in the ...
Detailed Description
Participants will receive Adebrelimab intravenously in combination with carboplatin /Cisplatin and etoposide during the induction phase (2 Cycles ). Thereafter, participants will receive concurrent ch...
Eligibility Criteria
Inclusion
- Signed inform consent form
- Age \>= 18 years and \<= 75 years
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system)，the number of metastatic lesions ≤ 5, the number of metastatic organs ≤ 3, and no previous systemic chemotherapy, radiotherapy or immune checkpoint inhibitor treatment.
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Expected survival time ≥ 3 months
- Patients must submit a pre-treatment tumor tissue sample during the study.
- Adequate hematologic and end organ function
Exclusion
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization
- Leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Uncontrolled or symptomatic hypercalcemia
- Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- History of autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease
- Prior treatment with immune checkpoint blockade therapies
- Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
- Significant cardiovascular disease
- Prior allogeneic bone marrow transplantation or solid organ transplant
- Treatment with systemic immunosuppressive medications within 1 weeks prior to randomization
- History of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, carboplatin or etoposide
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Key Trial Info
Start Date :
December 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06177925
Start Date
December 10 2023
End Date
September 30 2026
Last Update
December 20 2023
Active Locations (1)
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1
Nanfang Hospital, Southern Medical University
Guangzhou, China