Limbourg

Researchers are evaluating the safety and effectiveness of toripalimab alone or combined with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression after chemoradiotherapy. This Phase 3, randomized, double-blind, placebo-controlled, multi-regional study investigates these investigational treatments that are not yet approved for LS-SCLC in any country. Participants will receive one of three treatments every three weeks: toripalimab injection (240 mg), tifcemalimab injection (200 mg), or matching placebos. These treatments are given following completion of chemoradiotherapy, which includes chemotherapy with carboplatin or cisplatin plus etoposide and radiation therapy. Investigational treatment must begin within 42 days after the last chemotherapy dose. During the study, participants will be closely monitored for overall survival up to three years and progression-free survival up to two years. Researchers will assess treatment safety, disease status, organ function, and performance status. Participants must agree to follow all study procedures, including follow-up visits and evaluations throughout the study period.