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RECRUITING

NCT06095583

PHASE3

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)

Sponsor: Shanghai Junshi Bioscience Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

756

Start Date

2023-11-15

Completion Date

2029-07-31

Last Updated

2026-07-27

Healthy Volunteers

Conditions

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

Interventions

DRUG

Tifcemalimab injection

200mg once every 3weeks

DRUG

toripalimab injection

240mg once every 3 weeks

DRUG

Placebo for Tifcemalimab

every 3weeks

DRUG

Placebo for toripalimab

every 3weeks

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.

Locations (76)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Xiangya Hospital Central South University

Changsha, Hunan, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Cancer Hospital & Institute

Jinan, Shandong, China

Anyang Tumor Hospital

Anyang, China

Beijing Cancer Hospital

Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Jilin Cancer Hospital

Changchun, China

Hunan Cancer Hospital

Changsha, China

Sichuan cancer hospital

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Peking University Shenzhen Hospital

Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, China

No. 1 Bandong Road, Gongshu District, Hangzhou

Hangzhou, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

The First Affiliated Hospital of Ustc

Hefei, China

Henan Cancer Hospital

Henan, China

Affiliated Hospital of Jining Medical University

Jining, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The Second Affiliated Hospital of Nanchang University

Nanchang, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Fudan University Shanghai Cancer Center

Shanghai, China

Liaoning cancer hospital

Shenyang, China

Shanxi Cancer hospital

Taiyuan, China

Taizhou Hospital of Zhejiang Province

Taizhou, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Hubei Cancer Hospital (Hubei Cancer Research Institute)

Wuhan, China

Zhongnan Hospital of Wuhan University

Wuhan, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

General Hospital of Ningxia Medical University

Yinchuan, China

ISR-GEO Med Res Clin Healthycore

Tbilisi, K'alak'i T'bilisi, Georgia

Ltd New Hospitals

Tbilisi, K'alak'i T'bilisi, Georgia

Multprofil Clinic Consilium Medulla

Tbilisi, K'alak'i T'bilisi, Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, K'alak'i T'bilisi, Georgia

"TIM - Tbilisi Institute of Medicine" LTD

Tbilisi, Georgia

ICO-Institute of Clinical Oncology - Hospital

Tbilisi, Georgia

LTD "Israel-Georgian Medical Research Clinic Healthycore"

Tbilisi, Georgia

LTD "New Hospitals"

Tbilisi, Georgia

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Rijnstate Ziekenhuis

Arnhem, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Isala Klinieken Zwolle

Zwolle, Netherlands

Complexo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Universitari Dexeus Grupo Quironsalud

Barcelona, Spain

Complejo Hospitalario de Jaén

Jaén, Spain

Fundacion Jimenez Diaz

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Donostia

San Sebastián, Spain

H.C.U.Lozano Blesa

Zaragoza, Spain

Hospital Unviersitario Miguel Servet

Zaragoza, Spain

Taipei Veterans General Hospital

Taipei City, Taipei, Taiwan

No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.

Kaohsiung City, Taiwan

China Medical University Hospital - Internal Medicine - Taichung

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Chi Mei Hospital, Liouying - Department of Oncology

Tainan, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital - Internal Medicine

Taipei, Taiwan

Taipei Medical University - Shuang Ho Hospital

Taipei, Taiwan

Taipei Medical University - Taipei Medical University Hospital

Taipei, Taiwan

Taipei Medical University - WanFang Hospital - Hematology and Oncology

Taipei, Taiwan

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Ankara City Hospital

Ankara, Turkey (Türkiye)

Ankara Liv Hospital

Ankara, Turkey (Türkiye)

Gulhane Training and Research Hospital - Medical Oncology

Ankara, Turkey (Türkiye)

Memorial Ankara Hospital

Ankara, Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, Turkey (Türkiye)

Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology

Istanbul, Turkey (Türkiye)

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology

Istanbul, Turkey (Türkiye)

Ege University Medical Faculty - Pulmonary

Izmir, Turkey (Türkiye)

İzmir Ekonomi Üniversitesi Medical Point İzmir Hastanesi

Izmir, Turkey (Türkiye)

Katip Celebi University Ataturk Research and Training Hospit

Izmir, Turkey (Türkiye)

Kocaeli University Research and Practice Hospital

Kocaeli, Turkey (Türkiye)

Necmettin Erbakan University Meram

Konya, Turkey (Türkiye)

Inonu University Turgut Ozal Medical Center

Malatya, Turkey (Türkiye)

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (76)