Evaluation of Toripalimab Alone or with Tifcemalimab as Follow-Up Treatment for Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy

What this Trial Is About

Researchers are studying limited-stage small cell lung cancer LS-SCLC patients to evaluate the safety and effectiveness of toripalimab alone or combined with tifcemalimab as follow-up consolidation therapy. This Phase 3, randomized, double-blind, placebo-controlled, multi-regional trial enrolls patients who have completed chemoradiotherapy without disease progression. Tifcemalimab targets B and T lymphocyte attenuator BTLA, while toripalimab targets the programmed death protein-1 PD-1, and neither drug is yet approved for this condition. Participants are randomly assigned to one of three groups one receiving tifcemalimab 200 mg IV plus toripalimab 240 mg IV every three weeks, another receiving toripalimab 240 mg IV with a placebo for tifcemalimab, and a third group receiving placebos for both drugs. The investigational treatments are administered intravenously as consolidation therapy after chemoradiotherapy. Treatment continues according to the study schedule, with follow-up assessments planned to monitor outcomes. Throughout the study, participants will undergo evaluations including overall survival and progression-free survival measurements for up to three and two years, respectively. Researchers will also assess response rates, disease control, duration of response, and safety through monitoring adverse events and laboratory tests. The study involves regular visits for treatment and assessments, with close monitoring to understand the effects of the therapies over time.

Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)