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
14 countries
156
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
156 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
June 21, 2024
June 1, 2024
3.7 years
October 9, 2023
June 19, 2024
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 (156)
Banner MD Anderson Cancer Center
Goodyear, Arizona, 85338, United States
Banner University Medical Center
Tucson, Arizona, 85713, United States
Genesis Cancer and Blood Institute (Hot Springs, AR)
Hot Springs, Arkansas, 05001, United States
SCRI Nashville
Davis, California, 95616, United States
Zangmeister Cancer Center (Columbus, OH)
Los Angeles, California, 43219, United States
Los Angeles Hematology Oncology
Los Angeles, California, 90033, United States
University of Southern California Norris Comprehensive Cancer
Los Angeles, California, 90033, United States
Florida Cancer Specialists Pan Handle
Fort Myers, Florida, 32310, United States
Florida Cancer Specialists South
Fort Myers, Florida, 33908, United States
USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N
Miami, Florida, 33173, United States
Mid-Florida Hematology Oncology
Orange City, Florida, 55905, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060, United States
Norton Cancer Institute, Downtown, Multidisciplinary Clinic
Louisville, Kentucky, 40241, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817, United States
Dana Farber Cancer Institute-Hematology/Oncology
Boston, Massachusetts, 461099, United States
Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49502, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63101, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 07101, United States
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
New York, New York, 11776, United States
University of Stony Brook
Stony Brook, New York, 11794, United States
Toledo Clinic Cancer Center - Toledo
Toledo, Ohio, 97391, United States
Oncology Associates Of Oregon, P.C.
Eugene, Oregon, 97401, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Millennium Physicians - Oncology
Houston, Texas, 77090, United States
Texas Oncology, P.A. - Oncology
Tyler, Texas, 97402, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22030, United States
Algemeen Ziekenhuis Klina
Antwerp, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi, Belgium
AZ Groeningen
Kortrijk, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Limbourg, Belgium
CHU UCL Namur - Site Sainte-Elisabeth
Namur, Belgium
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
Centre Hospitalier Universitaire D Angers
Angers, France
Institut Bergonie
Bordeaux, France
Centre Hospitalier Intercommunal De Créteil
Créteil, France
CHU de Grenoble
Grenoble, France
Centre Leon Berard - departement d'oncologie medicale
Lyon, France
Centre de Cancérologie du Grand Montpellier
Montpellier, France
Hopital Arnaud De Villeneuve - Oncologie/Pneumologie
Montpellier, France
Hopital Haut-Leveque - Maladies respiratoires
Pessac, France
Chu Hôpitaux De Rouen
Rouen, France
Institut de Cancérologie de l'Ouest (ICO)
Saint-Herblain, France
Chru De Tours
Tours, France
Institut Gustave Roussy
Villejuif, France
"TIM - Tbilisi Institute of Medicine" LTD
Tbilisi, Georgia
ICO-Institute of Clinical Oncology - Hospital
Tbilisi, Georgia
ISR-GEO Med Res Clin Healthycore
Tbilisi, Georgia
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, Georgia
LTD "New Hospitals"
Tbilisi, Georgia
Ltd New Hospitals
Tbilisi, Georgia
Multprofil Clinic Consilium Medulla
Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, Georgia
Evangelische Lungenklinik Berlin
Berlin, Germany
Klinikum Esslingen GmbH Klinik für Kardiologie, Angiolgie und Pneumolgoie
Esslingen am Neckar, Germany
Univeristätsklinikum Giessen und Marburg GmbH
Giessen, Germany
Klinikum Kassel GmbH Klinik für Onkologie uind Hämatologie- Onkologisches Studiensekretariat
Kassel, Germany
Gemeinschaftspraxis fuer Haematologie und Onkologie
Münster, Germany
Universitätsklinikum Regensburg
Regensburg, Germany
PO G. Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania, Italy
Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS
Cesena, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Mod
Modena, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Napoli, Italy
Iov, Irccs
Padua, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavia
Pavia, Italy
AO S. Camillo-Forlanini
Roma, Italy
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS Feasibility survey: PO di Livorno, AUSL Toscana Nord Ovest, SST
Roma, Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Isala Klinieken Zwolle
Zwolle, Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
Olsztyn, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. E. i J. Zeylandow
Poznan, Poland
Instytut Gruzlicy i Chorob Pluc
Warsaw, Poland
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca, Romania
Medisprof
Cluj-Napoca, Romania
Centrul de Oncologie Sf. Nectarie
Craiova, Romania
Oncolab
Craiova, Romania
Radiotherapy Center Cluj
Floreşti, Romania
Oncomed
Timișoara, Romania
Chungbuk National University Hospital
Cheonju, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Centro Oncológico de Galicia
A Coruña, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Universitari Dexeus Grupo Quironsalud
Barcelona, Spain
C.H. Provincial de Castellón
Castellon, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Complejo Hospitalario Universitario de Orense
Ourense, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario Donostia
San Sebastián, Spain
Hospital Universitario Virgen De La Macarena
Seville, Spain
Hospital Arnau De Vilanova De Valencia
Valencia, Spain
Hospital Universitario Y Politécnico La Fe
Valencia, Spain
H.C.U.Lozano Blesa
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 District, 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
June 21, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share