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.
More Shanghai Junshi Bioscience Co., Ltd. trials in China
Other trials for the same condition
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 China