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)

The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy. Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.

NCT Number	NCT06095583
Lead Sponsor	Shanghai Junshi Bioscience Co., Ltd.
Conditions	Limited-stage Small Cell Lung Cancer (LS-SCLC)
Enrollment	756 participants
Start Date	2023-11-15
Primary Completion	2027-07-31 (estimated)
Study Completion	2029-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-27