Combining Adebrelimab with Chemotherapy and Radiotherapy for Advanced Small Cell Lung Cancer
A Phase Ⅱ Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy as First-Line Treatment for Extensive-Stage Oligometastatic Small Cell Lung Cancer
This study is testing whether adding a new drug called adebrelimab to chemotherapy and radiation can help people with advanced small cell lung cancer feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone, adebelizumab, Adebrelimab |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT06177925 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical study evaluates the safety and efficacy of adebrelimab in combination with carboplatin, cisplatin, and etoposide, alongside concurrent radiotherapy, for patients with extensive-stage oligometastatic small cell lung cancer. Participants will undergo an induction phase with two cycles of chemotherapy followed by concurrent chemoradiotherapy. Afterward, they will continue with maintenance therapy using adebrelimab until disease progression, intolerable toxicity, or withdrawal of consent. The study aims to provide a comprehensive treatment approach for this challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed extensive-stage small cell lung cancer and limited metastatic disease.
Not a fit: Patients with uncontrolled pleural effusion, leptomeningeal disease, or those who have received prior systemic chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with extensive-stage small cell lung cancer.
How similar studies have performed: While there have been studies exploring combinations of chemotherapy and immunotherapy for lung cancer, this specific combination and approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou
- Nanfang Hospital, Southern Medical University — Guangzhou, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.