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Clinical Trials in China / NCT06177925
Recruiting Phase 2

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

NCT06177925 · tracked via the Priya Life Science China tracker
Sponsor
Nanfang Hospital, Southern Medical University
Phase
Phase 2
Started
2023-12-10
Last updated
2023-12-20

Condition(s) studied

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsSmall Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

AdebrelimabCarboplatin/CisplatinEtoposideRadiation therapy

Adebrelimab: Adebrelimab intravenous infusion will be administered during the induction phase (Cycles 1-2 ) and maintenance phase.

Carboplatin/Cisplatin: Carboplatin/Cisplatin intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).

Etoposide: Etoposide intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).

Radiation therapy: IMRT for thoracic of 45--55Gy in 15-22 fractions,SBRT for metastases during the concurrent chemoradiotherapy phase

Study 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 first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Nanfang Hospital, Southern Medical University Guangzhou China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06177925 on ClinicalTrials.gov ↗ ← All trials in China