NCT06095583

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)

A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 756 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Limited-stage Small Cell Lung Cancer (LS-SCLC)

Interventions

Type	Name	Description
DRUG	Tifcemalimab injection	200mg once every 3weeks
DRUG	toripalimab injection	240mg once every 3 weeks
DRUG	Placebo for Tifcemalimab	every 3weeks
DRUG	Placebo for toripalimab	every 3weeks

Timeline

• Start date: 2023-11-15
• Primary completion: 2027-07-31
• Completion: 2029-07-31
• First posted: 2023-10-23
• Last updated: 2024-06-21

Locations

156 sites across 14 countries: United States, Belgium, China, France, Georgia, Germany, Italy, Netherlands, Poland, Romania, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study