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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Tifcemalimab injection: 200mg once every 3weeks
toripalimab injection: 240mg once every 3 weeks
Placebo for Tifcemalimab: every 3weeks
Placebo for toripalimab: every 3weeks
Study 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.
Eligibility
Primary outcome measure(s)
- Overall survival (OS) — up to 3years
To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after chemoradiotherapy (CRT) for patients with LS-SCLC as measured by OS - OS — up to 3years
To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by OS" - Progression-free survival (PFS) — up to 2years
To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by Blinded Independent Review Committee (BIRC)-assessed PFS. - Progression-free survival (PFS) — up to 2years
To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by OS and BIRC-assessed PFS.
Trial sites (76)
| Facility | City | Region | Status |
|---|---|---|---|
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | Recruiting |
| Xiangya Hospital Central South University | Changsha | Hunan | Recruiting |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | Recruiting |
| The First Hospital of China Medical University | Shenyang | Liaoning | Recruiting |
| Shandong Cancer Hospital & Institute | Jinan | Shandong | Recruiting |
| Anyang Tumor Hospital | Anyang | China | Recruiting |
| Beijing Cancer Hospital | Beijing | China | Not Yet Recruiting |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | China | Recruiting |
| Jilin Cancer Hospital | Changchun | China | Recruiting |
| Hunan Cancer Hospital | Changsha | China | Recruiting |
| Sichuan cancer hospital | Chengdu | China | Not Yet Recruiting |
| Chongqing University Cancer Hospital | Chongqing | China | Recruiting |
| Peking University Shenzhen Hospital | Guangdong | China | Not Yet Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou | China | Recruiting |
| No. 1 Bandong Road, Gongshu District, Hangzhou | Hangzhou | China | Recruiting |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of Ustc | Hefei | China | Recruiting |
| Henan Cancer Hospital | Henan | China | Not Yet Recruiting |
| Affiliated Hospital of Jining Medical University | Jining | China | Not Yet Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang | China | Recruiting |
| The Second Affiliated Hospital of Nanchang University | Nanchang | China | Recruiting |
| The Affiliated Hospital of Qingdao University | Qingdao | China | Not Yet Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | China | Not Yet Recruiting |
| Liaoning cancer hospital | Shenyang | China | Not Yet Recruiting |
| Shanxi Cancer hospital | Taiyuan | China | Recruiting |
| Taizhou Hospital of Zhejiang Province | Taizhou | China | Not Yet Recruiting |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | China | Recruiting |
| Hubei Cancer Hospital (Hubei Cancer Research Institute) | Wuhan | China | Recruiting |
| Zhongnan Hospital of Wuhan University | Wuhan | China | Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen | China | Not Yet Recruiting |
| General Hospital of Ningxia Medical University | Yinchuan | China | Recruiting |
| ISR-GEO Med Res Clin Healthycore | Tbilisi | K'alak'i T'bilisi | Recruiting |
| Ltd New Hospitals | Tbilisi | K'alak'i T'bilisi | Recruiting |
| Multprofil Clinic Consilium Medulla | Tbilisi | K'alak'i T'bilisi | Recruiting |
| Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic | Tbilisi | K'alak'i T'bilisi | Recruiting |
| "TIM - Tbilisi Institute of Medicine" LTD | Tbilisi | Georgia | Not Yet Recruiting |
| ICO-Institute of Clinical Oncology - Hospital | Tbilisi | Georgia | Recruiting |
| LTD "Israel-Georgian Medical Research Clinic Healthycore" | Tbilisi | Georgia | Recruiting |
| LTD "New Hospitals" | Tbilisi | Georgia | Recruiting |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Netherlands | Not Yet Recruiting |
+ 36 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06095583 on ClinicalTrials.gov ↗ ← All trials in Spain