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Clinical Trials in China / NCT06095583
Recruiting Phase 3

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)

NCT06095583 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Phase
Phase 3
Started
2023-11-15
Last updated
2026-07-27

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Tifcemalimab injectiontoripalimab injectionPlacebo for TifcemalimabPlacebo for toripalimab

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be enrolled: 1. Male or female with age ≥ 18 years old at the time of informed consent. 2. Histologically or cytologically confirmed LS-SCLC using the Veteran's Administration Lung Study Arm (VALSG) staging criteria (Appendix 3). Patients with TNM Stage I or II disease per AJCC 8th edition must be medically inoperable (as determined by the Investigator) or the patient must refuse surgery. 3. Received CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total radiation dose of 60-66 Gy for the standard once daily (QD) radiotherapy regimen or 45 Gy for the hyperfractionated twice daily (BID) radiotherapy regimen; (3) Patients must begin investigational interventions within 42 days of the last dose of chemotherapy. 4. Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 . 6. Adequate organ function 7. Female patients of childbearing potential and male patients whose partners are women of childbearing age. 8. Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures. Exclusion Criteria: Patients will be excluded from the study if they meet any of the following criteria. 1. Mixed SCLC and non-small cell lung cancer (NSCLC). 2. Received sequential chemoradiotherapy for LS-SCLC. 3. Failure to recover from toxicity of prior anticancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (except alopecia) or levels specified in the inclusion/exclusion criteria, whichever is more severe. 4. Patients with active autoimmune disease, history of autoimmune disease. 5. History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation. 6. History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids). 7. The presence of active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibodies positive and HCV-RNA higher than the lower limit of detection of the analytical method). 8. Any other malignancy diagnosed prior to the first dose of investigational intervention, except those with a low risk for the development of metastases (5-year survival rate \> 90%), such as adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated localized prostate cancer. 9. Women who are pregnant or breastfeeding.

Primary outcome measure(s)

Trial sites (76)

FacilityCityRegionStatus
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

Official registry record

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