A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Dec 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with extensive-stage oligometastatic small cell lung cancer (SCLC), a type of lung cancer that has spread to other parts of the body. The treatment combines a medication called adebrelimab with chemotherapy drugs (carboplatin or cisplatin plus etoposide) and radiation therapy. The goal is to see how well this combination works and how safe it is for patients who have not received any previous treatment for their cancer.

To be eligible for the trial, participants need to be between 18 and 75 years old and have a confirmed diagnosis of extensive-stage SCLC with a limited number of metastatic lesions (cancer spread). They should also be in reasonably good health, with an expected survival time of at least three months. Participants will need to provide a tumor sample and will be closely monitored throughout the study. This trial is currently recruiting participants, and it’s important for potential volunteers to discuss with their doctors to understand if they meet the criteria and if this trial is right for them.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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