Study of Low-Dose Radiotherapy Plus Sugemalimab, Olaparib, and Chemotherapy for First-Line Treatment of SLFN-11 Positive Extensive Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are studying the safety and effectiveness of combining low-dose radiotherapy LDRT with sugemalimab, olaparib, and chemotherapy as a first treatment for patients with SLFN-11 positive extensive stage small cell lung cancer ES-SCLC. This study includes both dose escalation and dose expansion phases. The goal is to assess how well this combination treatment works and how safe it is for patients with this advanced lung cancer type. Participants will receive four cycles of treatment every 21 days. In the first cycle, low-dose radiotherapy targets the primary tumor with 15 Gy over five days. Chemotherapy drugs etoposide and cisplatin are given intravenously on days 1, 2, and 3 of each cycle. Sugemalimab is infused at 1200 mg on day 1 of each cycle. Olaparib is taken orally in varying doses during each cycle. After these four cycles, sugemalimab and olaparib continue as maintenance therapy until the cancer progresses, side effects become unacceptable, consent is withdrawn, or death occurs. During the study, participants will be closely monitored for safety and treatment effects, including tumor response and survival outcomes. Imaging scans and other assessments will be done to measure tumor size and progression. The primary outcome is to find the recommended dose for expansion three weeks after starting treatment. Secondary outcomes include progression-free survival, overall survival, and response rates measured over up to two years. Participants will be observed throughout the treatment and follow-up periods, which may last up to two years or until disease progression.

Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC