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)
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
1 other identifier
interventional
756
6 countries
76
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
Longer than P75 for phase_3
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
July 27, 2026
July 1, 2026
3.7 years
October 9, 2023
July 23, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Overall survival (OS)
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
up to 3years
OS
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"
up to 3years
Progression-free survival (PFS)
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.
up to 2years
Progression-free survival (PFS)
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.
up to 2years
Secondary Outcomes (14)
PFS
up to 2years
1-year OS rate
up to 1year
2-year OS rate
up to 2 years
objective response rate (ORR)
up to 2 years
disease control rate (DCR)
up to 2 years
- +9 more secondary outcomes
Study Arms (3)
Experimental group A
EXPERIMENTALTifcemalimab (200 mg intravenous infusion \[IV\]) and toripalimab (240 mg IV)
Experimental group B
EXPERIMENTALPlacebo for tifcemalimab (IV) and toripalimab (240 mg IV)
Placebo group C
PLACEBO COMPARATORPlacebos for both tifcemalimab and toripalimab (IV)
Interventions
Eligibility Criteria
You may qualify if:
- Male or female with age ≥ 18 years old at the time of informed consent.
- 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.
- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 .
- Adequate organ function
- Female patients of childbearing potential and male patients whose partners are women of childbearing age.
- Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures.
You may not qualify if:
- Patients will be excluded from the study if they meet any of the following criteria.
- Mixed SCLC and non-small cell lung cancer (NSCLC).
- Received sequential chemoradiotherapy for LS-SCLC.
- Patients with active autoimmune disease, history of autoimmune disease.
- History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
- History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids).
- 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).
- 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.
- Women who are pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2023
First Posted
October 23, 2023
Study Start
November 15, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2029
Last Updated
July 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share