Study of Low-Dose Radiotherapy Concurrent Cisplatin/Carboplatin Plus Etoposide With Serplulimab for Patients With ES-SCLC
Extensive-stage Small-cell Lung Cancer
About this trial
This is an interventional treatment trial for Extensive-stage Small-cell Lung Cancer
Eligibility Criteria
Main Inclusion Criteria: Histologically or cytologically confirmed ES-SCLC No prior treatment for ES-SCLC Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation. ECOG performance status of 0 or 1 Life expectancy >= 3 months Adequate hematologic and end-organ function For participants receiving therapeutic anticoagulation: stable anticoagulant regimen Negative human immunodeficiency virus (HIV) test at screening Negative hepatitis B surface antigen (HBsAg) test at screening Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test will be performed only for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for participants who have a positive HCV antibody test. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm Main Exclusion Criteria: Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases Participants with pulmonary artery invasion History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan Active tuberculosis Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina History of malignancy other than small cell lung cancer (SCLC) within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Sites / Locations
- Cancer Hospital of Shantou University Medical College
- The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- LiaoNing Cancer Hospital & Institute
- Shandong Provincial Hospital
- Fudan University Shanghai Cancer Center
- China West Hospital
Arms of the Study
Arm 1
Experimental
LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab
Participants will receive the following treatment regimens: LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab. Induction treatment will be administered on a 21-day cycle for four cycles. Concurrent radiation therapy will be conducted from Day 1 - Day 5 in the first cycle. Following the induction phase, participants will continue maintenance therapy with serplulimab and thoracic radiation therapy (30Gay/10f). Participants will be treated until loss of clinical benefit, or unaccepted toxicity, or withdrawal of consent, or death (whichever occurs first).