Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC (NCT05765825) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC
China61 participantsStarted 2023-03-07
Plain-language summary
This is a Phase II, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) concurrent cisplatin/carboplatin plus etoposide with serplulimab in participants who have extensive-stage small cell lung cancer (ES-SCLC) and are chemotherapy-navïe for their extensive-stage disease.
Who can participate
Age range18 Years
SexALL
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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
Exclusion criteria
✕. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
✕. 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