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)
Part of paid clinical trials in Goodyear, Arizona.
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Study ID
- NCT06095583
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Limited-stage Small Cell Lung Cancer (LS-SCLC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tifcemalimab injection — DRUG200mg once every 3weeks
- toripalimab injection — DRUG240mg once every 3 weeks
- Placebo for Tifcemalimab — DRUGevery 3weeks
- Placebo for toripalimab — DRUGevery 3weeks
Study Details
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.
Key Dates
- Start date
- Nov 15, 2023
- Status verified
- Jun 2024
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2029
Study Design
- Enrollment
- 756 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental group ATifcemalimab (200 mg intravenous infusion \[IV\]) and toripalimab (240 mg IV)
- Experimental: Experimental group BPlacebo for tifcemalimab (IV) and toripalimab (240 mg IV)
- Placebo Comparator: Placebo group CPlacebos for both tifcemalimab and toripalimab (IV)
Primary Outcome Measure
Overall survival (OS) [ Time Frame: up to 3years ]
Central Contacts
- kui zhang, Project Directer08618168028925
- Kinga Kovacs, Senior Project Leader+ 31 6 45974346