At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at informed consent
- ✓Histologically or cytologically confirmed LS-SCLC per VALSG staging; TNM Stage I-II must be medically inoperable or patient refuses surgery
- ✓Completed CRT: 4 cycles carboplatin/cisplatin + etoposide, 60-66 Gy QD or 45 Gy BID radiation
- ✓Start investigational intervention within 42 days of last chemotherapy dose
- ✕Mixed SCLC and non-small cell lung cancer
- ✕Received sequential chemoradiotherapy for LS-SCLC
- ✕Failure to recover from prior anticancer therapy toxicity to CTCAE Grade ≤1 (except alopecia)
- ✕Active or history of autoimmune disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Tifcemalimab injection, toripalimab injection, and 2 other interventions for Limited-stage Small Cell Lung Cancer (LS-SCLC). Currently recruiting, targeting 756 participants across 156 sites in 14 countries.
Detailed 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.
Study Details
Timeline
Interventions
200mg once every 3weeks
240mg once every 3 weeks
every 3weeks
every 3weeks