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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

2024-06-21

Healthy Volunteers

No

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

Locations (156)

Banner MD Anderson Cancer Center

Goodyear, Arizona, United States

Banner University Medical Center

Tucson, Arizona, United States

Genesis Cancer and Blood Institute (Hot Springs, AR)

Hot Springs, Arkansas, United States

SCRI Nashville

Davis, California, United States

Zangmeister Cancer Center (Columbus, OH)

Los Angeles, California, United States

Los Angeles Hematology Oncology

Los Angeles, California, United States

University of Southern California Norris Comprehensive Cancer

Los Angeles, California, United States

Florida Cancer Specialists Pan Handle

Fort Myers, Florida, United States

Florida Cancer Specialists South

Fort Myers, Florida, United States

USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N

Miami, Florida, United States

Mid-Florida Hematology Oncology

Orange City, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, United States

Norton Cancer Institute, Downtown, Multidisciplinary Clinic

Louisville, Kentucky, United States

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States

Dana Farber Cancer Institute-Hematology/Oncology

Boston, Massachusetts, United States

Karmanos Cancer Center

Detroit, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists

New York, New York, United States

University of Stony Brook

Stony Brook, New York, United States

Toledo Clinic Cancer Center - Toledo

Toledo, Ohio, United States

Oncology Associates Of Oregon, P.C.

Eugene, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Millennium Physicians - Oncology

Houston, Texas, United States

Texas Oncology, P.A. - Oncology

Tyler, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, 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

Naples, Italy

Iov, Irccs

Padova, 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)