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)
June 19, 2024 updated by: Shanghai Junshi Bioscience Co., Ltd.
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
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.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Estimated)
756
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kui Zhang, Project Directer
- Phone Number: 08618168028925
- Email: kui_zhang@junshipharma.com
Study Contact Backup
- Name: Kinga Kovacs, Senior Project Leader
- Phone Number: + 31 6 45974346
- Email: Kinga.Kovacs@parexel.com
Study Locations
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Antwerpen, Belgium
- Not yet recruiting
- Algemeen Ziekenhuis klina
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Contact:
- Wim Demey
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Charleroi, Belgium
- Not yet recruiting
- Grand Hôpital de Charleroi - Site Notre-Dame
-
Contact:
- Colinet Benoit
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Kortrijk, Belgium
- Not yet recruiting
- AZ Groeningen
-
Contact:
- Sofie Derijcke
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Limbourg, Belgium
- Not yet recruiting
- Jessa Ziekenhuis - Campus Virga Jesse
-
Contact:
- Kristof Cuppens
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Namur, Belgium
- Not yet recruiting
- CHU Ucl Namur - Site Sainte-Elisabeth
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Contact:
- Jean-Charles Goeminne
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Anyang, China
- Recruiting
- AnYang Tumor Hospital
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Contact:
- Anping Zheng
-
Beijing, China
- Recruiting
- Cancer Hospital Chinese Academy of Medical Sciences
-
Contact:
- Zhouguang Hui
-
Beijing, China
- Not yet recruiting
- Beijing Cancer Hospital
-
Contact:
- Anhui Shi
-
Changchun, China
- Recruiting
- Jilin Cancer Hospital
-
Contact:
- Ying Cheng
-
Changsha, China
- Recruiting
- Hunan Cancer Hospital
-
Contact:
- Hui Wang
-
Chengdu, China
- Not yet recruiting
- Sichuan Cancer Hospital
-
Contact:
- Wenxiu Yao
-
Chongqing, China
- Recruiting
- Chongqing University Cancer Hospital
-
Contact:
- Ying Wang
-
Guangdong, China
- Not yet recruiting
- Peking University Shenzhen Hospital
-
Contact:
- Yajie Liu
-
Guangzhou, China
- Recruiting
- Sun yat-sen University Cancer Center
-
Contact:
- Ming Chen
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Hangzhou, China
- Recruiting
- the Second Affiliated Hospital Zhejiang University School of Medicine
-
Contact:
- Wen Li
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Hangzhou, China
- Recruiting
- No. 1 Bandong Road, Gongshu District, Hangzhou
-
Contact:
- Yongling Ji
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Hefei, China
- Recruiting
- The First Affiliated hospital of USTC
-
Contact:
- Dong Qian
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Contact:
- Junqiang Zhang
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Henan, China
- Not yet recruiting
- Henan Cancer Hospital
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Contact:
- Hong Ge
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Jining, China
- Not yet recruiting
- Affiliated Hospital of Jining Medical University
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Contact:
- Shucheng Ye
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Nanchang, China
- Recruiting
- The First Affiliated Hospital of Nanchang University
-
Contact:
- Longhua Sun
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Nanchang, China
- Recruiting
- The Second Affiliated Hospital of Nanchang University
-
Contact:
- Anwen Liu
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Qingdao, China
- Not yet recruiting
- The affiliated hospital of Qingdao university
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Contact:
- Jing Wang
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Shanghai, China
- Not yet recruiting
- Fudan University Shanghai Cancer Center
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Contact:
- Ming Fan
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Shenyang, China
- Not yet recruiting
- Liaoning Cancer Hospital
-
Contact:
- Xiaoling Li
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Taiyuan, China
- Recruiting
- Shanxi Cancer Hospital
-
Contact:
- Jie Li
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Taizhou, China
- Not yet recruiting
- Taizhou Hospital of Zhejiang Province
-
Contact:
- Dongqing Lv
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Tianjin, China
- Recruiting
- Tianjin Medical University Cancer Institute & Hospital
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Contact:
- Lujun Zhao
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Wuhan, China
- Recruiting
- Zhongnan Hospital of Wuhan University
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Contact:
- Conghua Xie
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Wuhan, China
- Recruiting
- Hubei Cancer Hospital (Hubei Cancer Research Institute)
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Contact:
- Desheng Hu
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Contact:
- Yi Peng
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Xiamen, China
- Not yet recruiting
- The First Affiliated Hospital of Xiamen University
-
Contact:
- Qin Lin
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Yinchuan, China
- Recruiting
- General Hospital of Ningxia Medical University
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Contact:
- Ren Zhao
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Heilongjiang
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Harbin, Heilongjiang, China
- Recruiting
- Harbin Medical University Cancer Hospital
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Contact:
- yan Yu
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Hunan
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Changsha, Hunan, China
- Recruiting
- Xiangya Hospital Central South University
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Contact:
- Rongrong Zhou
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Jiangxi
-
Nanchang, Jiangxi, China
- Recruiting
- The Second Affiliated Hospital of Nanchang University
-
Contact:
- Anwen Liu
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Liaoning
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Shenyang, Liaoning, China
- Recruiting
- The First Hospital of China Medical University
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Contact:
- Bo Jin
-
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Shandong
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Jinan, Shandong, China
- Recruiting
- Shandong Cancer Hospital & Institute
-
Contact:
- Jinming Yu, MD, PhD,
- Phone Number: 86 13806406293
- Email: sdyujinming@126.com
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Principal Investigator:
- Jinming Yu, MD, PhD,
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Angers, France
- Not yet recruiting
- Centre Hospitalier Universitaire D Angers
-
Contact:
- Youssef Oulkhouir
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Bordeaux, France
- Not yet recruiting
- Institut Bergonié
-
Contact:
- Sophie Cousin
-
Créteil, France
- Not yet recruiting
- Centre Hospitalier Intercommunal de Creteil
-
Contact:
- Isabelle MONNET
-
Grenoble, France
- Not yet recruiting
- Chu de Grenoble
-
Contact:
- Denis MORO-SIBILOT
-
Lyon, France
- Not yet recruiting
- Centre Leon Berard - departement d'oncologie medicale
-
Contact:
- Maurice Perol
-
Montpellier, France
- Not yet recruiting
- Centre de Cancerologie du Grand Montpellier
-
Contact:
- Ivan Toledano
-
Montpellier, France
- Not yet recruiting
- Hopital Arnaud De Villeneuve - Oncologie/Pneumologie
-
Contact:
- Jean-Louis Pujol
-
Pessac, France
- Not yet recruiting
- Hopital Haut-Leveque - Maladies respiratoires
-
Contact:
- Remi Veillon
-
Rouen, France
- Not yet recruiting
- CHU hopitaux de rouen
-
Contact:
- Florian Guisier
-
Saint-Herblain, France
- Not yet recruiting
- Institut de Cancérologie de l'Ouest (ICO)
-
Contact:
- Sandrine Hiret
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Tours Cedex 9, France
- Not yet recruiting
- Chru De Tours
-
Contact:
- Eric Pichon
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Villejuif, France
- Not yet recruiting
- Institut Gustave Roussy
-
Contact:
- Lavaud Pernelle
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Tbilisi, Georgia
- Recruiting
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
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Contact:
- Miranda Gogishvili
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Tbilisi, Georgia
- Recruiting
- LTD New Hospitals
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Contact:
- Davit Giorgadze
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Tbilisi, Georgia
- Recruiting
- ICO-Institute of Clinical Oncology - Hospital
-
Contact:
- Vladimer Kuchava
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Tbilisi, Georgia
- Recruiting
- ISR-GEO Med Res Clin Healthycore
-
Contact:
- Ekaterine Arkania
-
Tbilisi, Georgia
- Recruiting
- Multprofil Clinic Consilium Medulla
-
Contact:
- Tsira Kortua
-
Tbilisi, Georgia
- Recruiting
- LTD "Israel-Georgian Medical Research Clinic Healthycore"
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Contact:
- Ekaterine Arkania
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Tbilisi, Georgia
- Recruiting
- Ltd "New Hospitals"
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Contact:
- Davit Giorgadze
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Tbilisi, Georgia
- Not yet recruiting
- "TIM - Tbilisi Institute of Medicine" LTD
-
Contact:
- Mariam Zhvania
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-
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Berlin, Germany
- Not yet recruiting
- Evangelische Lungenklinik Berlin
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Contact:
- Christian Grohé
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Esslingen, Germany
- Not yet recruiting
- Klinikum Esslingen GmbH Klinik für Kardiologie, Angiolgie und Pneumolgoie
-
Contact:
- Martin Faehling
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Gießen, Germany
- Not yet recruiting
- Univeristätsklinikum Giessen und Marburg GmbH
-
Contact:
- Thomas Wehler
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Kassel, Germany
- Not yet recruiting
- Klinikum Kassel GmbH Klinik für Onkologie uind Hämatologie- Onkologisches Studiensekretariat
-
Contact:
- Martin Wolf
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Münster, Germany
- Not yet recruiting
- Gemeinschaftspraxis fuer Haematologie und Onkologie
-
Contact:
- Rüdiger Liersch
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Regensburg, Germany
- Not yet recruiting
- Universitätsklinikum Regensburg
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Contact:
- Christian Schulz
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Catania, Italy
- Not yet recruiting
- PO G. Rodolico, AOU Policlinico-Vittorio Emanuele Catania
-
Contact:
- Hector Jose Soto Parra
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Cesena, Italy
- Not yet recruiting
- Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS
-
Contact:
- Angelo Delmonte
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Firenze, Italy
- Not yet recruiting
- Azienda Ospedaliero Universitaria Careggi
-
Contact:
- Lorenzo Antonuzzo
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Modena, Italy
- Not yet recruiting
- Azienda Ospedaliero-Universitaria di Modena, Policlinico di Mod
-
Contact:
- Bertolini Federica
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Napoli, Italy
- Not yet recruiting
- Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
-
Contact:
- Ferdinando Riccardi
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Padova, Italy
- Not yet recruiting
- Iov, Irccs
-
Contact:
- Laura Bonnano
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Pavia, Italy
- Not yet recruiting
- IRCCS Policlinico San Matteo, Università degli studi di Pavia
-
Contact:
- Andrea Filippi
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Roma, Italy
- Not yet recruiting
- AO S. Camillo-Forlanini
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Contact:
- Ricciardi Serena
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Roma, Italy
- Not yet recruiting
- Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS Feasibility survey: PO di Livorno, AUSL Toscana Nord Ovest, SST
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Contact:
- Federico Cappuzzo
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Cheonju, Korea, Republic of
- Not yet recruiting
- Chungbuk National University Hospital
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Contact:
- Ki Hyeong Lee,
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Seongnam, Korea, Republic of
- Not yet recruiting
- Seoul National University Bundang Hospital
-
Contact:
- Yu Jung 유정 Kim 김,
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Seoul, Korea, Republic of
- Not yet recruiting
- Severance Hospital, Yonsei University Health System
-
Contact:
- Sun선, Min민 Lim임,
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Arnhem, Netherlands
- Not yet recruiting
- Rijnstate Ziekenhuis
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Contact:
- Claessens Niels
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Herzogenbusch, Netherlands
- Not yet recruiting
- Jeroen Bosch Ziekenhuis
-
Contact:
- van Veggel B.A.M.H. (Bianca)
-
Rotterdam, Netherlands
- Not yet recruiting
- Erasmus Medisch Centrum
-
Contact:
- Dumoulin Daphne
-
Zwolle, Netherlands
- Not yet recruiting
- Isala Klinieken Zwolle
-
Contact:
- Plomp Peter
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Białystok, Poland
- Not yet recruiting
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
Contact:
- Robert Mroz
-
Olsztyn, Poland
- Not yet recruiting
- SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
-
Contact:
- Sergiusz Nawrocki
-
Poznań, Poland
- Not yet recruiting
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. E. i J. Zeylandow
-
Contact:
- Katarzyna Stencel
-
Warszawa, Poland
- Not yet recruiting
- Instytut Gruzlicy i Chorob Pluc
-
Contact:
- Mateusz Polaczek
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-
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Cluj-Napoca, Romania
- Not yet recruiting
- Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
-
Contact:
- Alina Simona MUNTEAN
-
Cluj-Napoca, Romania
- Not yet recruiting
- Medisprof
-
Contact:
- Anghel Adrian UDREA
-
Craiova, Romania
- Not yet recruiting
- Centrul de Oncologie Sf. Nectarie
-
Contact:
- Michael Schenker
-
Craiova, Romania
- Not yet recruiting
- Oncolab
-
Contact:
- Dan Lungulescu
-
Floreşti, Romania
- Not yet recruiting
- Radiotherapy Center Cluj
-
Contact:
- Andrei Ungureanu
-
Timişoara, Romania
- Not yet recruiting
- OncoMed
-
Contact:
- Serban Mircea Negru
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Barcelona, Spain
- Not yet recruiting
- Hospital Universitari Dexeus Grupo Quironsalud
-
Contact:
- Ivana Gabriela Sullivan
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Castellón De La Plana, Spain
- Not yet recruiting
- C.H. Provincial de Castellón
-
Contact:
- Alfredo Sánchez Hernández
-
Coruña, Spain
- Not yet recruiting
- Centro Oncologico de Galicia
-
Contact:
- Margarita Amenedo Gancedo
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Coruña, Spain
- Not yet recruiting
- Complexo Hospitalario Universitario A Coruña
-
Contact:
- Maria Rosario Garcia Campelo
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Jaén, Spain
- Not yet recruiting
- Complejo Hospitalario de Jaén
-
Contact:
- Ana Laura Ortega Granados
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Madrid, Spain
- Not yet recruiting
- Hospital Universitario La Paz
-
Contact:
- Javier de Castro Carpeño
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Madrid, Spain
- Not yet recruiting
- Hospital Clinico San Carlos
-
Contact:
- Jose González Larriba
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Madrid, Spain
- Not yet recruiting
- Fundacion Jimenez Diaz
-
Contact:
- Manuel Domine Gomez
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Orense, Spain
- Not yet recruiting
- Complejo Hospitalario Universitario de Orense
-
Contact:
- Maria Areses Manrique
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Oviedo, Spain
- Not yet recruiting
- Hospital Universitario Central de Asturias
-
Contact:
- Noemí Villanueva Palicio
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San Sebastián, Spain
- Not yet recruiting
- Hospital Universitario Donostia
-
Contact:
- Ibone de Elejoste Echebarria
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Sevilla, Spain
- Not yet recruiting
- Hospital Universitario Virgen de la Macarena
-
Contact:
- David Vincente Baz
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Valencia, Spain
- Not yet recruiting
- Hospital Universitario y Politécnico La Fe
-
Contact:
- Oscar Juan Vidal
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Valencia, Spain
- Not yet recruiting
- Hospital Arnau de Vilanova de Valencia
-
Contact:
- Javier Garde Noguera,
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Zaragoza, Spain
- Not yet recruiting
- H.C.U.Lozano Blesa
-
Contact:
- Maria Dolores Isla Casado
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Kaohsiung, Taiwan
- Recruiting
- No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.
-
Contact:
- Chin-Chou 金洲 Wang 王
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Taichung, Taiwan
- Recruiting
- Taichung Veterans General Hospital
-
Contact:
- Tsung-Ying 宗穎 Yang 楊
-
Taichung, Taiwan
- Not yet recruiting
- China Medical University Hospital - Internal Medicine - Taichung
-
Contact:
- Te-Chun 德椿 Hsia 夏
-
Tainan, Taiwan
- Recruiting
- Chi Mei Hospital, Liouying - Department of Oncology
-
Contact:
- Wan-Chen婉真 Kao高
-
Tainan City, Taiwan
- Recruiting
- National Cheng Kung University Hospital
-
Contact:
- Chun Hui Lee
-
Taipei, Taiwan
- Recruiting
- Taipei Medical University - Shuang Ho Hospital
-
Contact:
- Kang-Yun 岡遠 Lee 李
-
Taipei, Taiwan
- Recruiting
- Taipei Medical University - Taipei Medical University Hospital
-
Contact:
- Shih-Hsin 世欣 Hsiao 蕭
-
Taipei, Taiwan
- Recruiting
- Taipei Medical University - WanFang Hospital - Hematology and Oncology
-
Contact:
- Han-Lin 翰琳 Hsu 許
-
Taipei, Taiwan
- Not yet recruiting
- National Taiwan University Hospital - Internal Medicine
-
Contact:
- Chih-Hsin 志新 Yang 楊
-
Taoyuan, Taiwan
- Recruiting
- Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
-
Contact:
- Chien-Ying 劍英 Liu 劉
-
-
Taipei
-
Taipei city, Taipei, Taiwan
- Recruiting
- Taipei Veterans General Hospital
-
Contact:
- Yuh-Min Chen
-
-
-
-
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Ankara, Turkey
- Not yet recruiting
- Ankara City Hospital
-
Contact:
- Mehmet Sendur
-
Ankara, Turkey
- Recruiting
- Memorial Ankara Hospital
-
Contact:
- Umut Demirici
-
Ankara, Turkey
- Not yet recruiting
- Ankara Liv Hospital
-
Contact:
- Saadettin Kilickap
-
Ankara, Turkey
- Not yet recruiting
- Gulhane Training and Research Hospital - Medical Oncology
-
Contact:
- Nuri Karadurmus
-
Edirne, Turkey
- Not yet recruiting
- Trakya University Medical Faculty
-
Contact:
- Muhammet Hacioglu
-
Istanbul, Turkey
- Not yet recruiting
- Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology
-
Contact:
- Deniz Tural
-
Istanbul, Turkey
- Not yet recruiting
- Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
-
Contact:
- Mahmut Gumus
-
Kocaeli, Turkey
- Recruiting
- Kocaeli University Research and Practice Hospital
-
Contact:
- Devrim Cabuk
-
Konya, Turkey
- Recruiting
- Necmettin Erbakan University Meram
-
Contact:
- Mehmet Artac
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Malatya, Turkey
- Not yet recruiting
- Inonu University Turgut Ozal Medical Center
-
Contact:
- Hakan Harputluoglu
-
İzmir, Turkey
- Not yet recruiting
- Ege University Medical Faculty - Pulmonary
-
Contact:
- Tuncay Goksel
-
İzmir, Turkey
- Not yet recruiting
- İzmir Ekonomi Üniversitesi Medical Point İzmir Hastanesi
-
Contact:
- Arslan Cagatay
-
İzmir, Turkey
- Not yet recruiting
- Katip Celebi University Ataturk Research and Training Hospit
-
Contact:
- Ahmet Alacacioglu
-
-
-
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Arizona
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Goodyear, Arizona, United States, 85338
- Not yet recruiting
- Banner MD Anderson Cancer Center
-
Contact:
- Jiaxin Niu
-
Tucson, Arizona, United States, 85713
- Not yet recruiting
- Banner University Medical Center
-
Contact:
- Charles Hsu
-
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Arkansas
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Hot Springs, Arkansas, United States, 05001
- Not yet recruiting
- Genesis Cancer and Blood Institute (Hot Springs, AR)
-
Contact:
- Roy Timothy Webb
-
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California
-
Davis, California, United States, 95616
- Not yet recruiting
- SCRI Nashville
-
Contact:
- Jhonson Melissa
-
Los Angeles, California, United States, 90033
- Recruiting
- University of Southern California Norris Comprehensive Cancer
-
Contact:
- Robert Hsu,
-
Los Angeles, California, United States, 43219
- Not yet recruiting
- Zangmeister Cancer Center (Columbus, OH)
-
Contact:
- Jorge Rios-Perez
-
Los Angeles, California, United States, 90033
- Not yet recruiting
- Los Angeles Hematology Oncology
-
Contact:
- Lasika Seneviratne,
-
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Florida
-
Fort Myers, Florida, United States, 32310
- Not yet recruiting
- Florida Cancer Specialists Pan Handle
-
Contact:
- Jeffrey Bubis
-
Fort Myers, Florida, United States, 33908
- Not yet recruiting
- Florida Cancer Specialists South
-
Contact:
- Alexander Glick
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Miami, Florida, United States, 33173
- Not yet recruiting
- USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N
-
Contact:
- Ikpeazu Chukwuemeka
-
Orange City, Florida, United States, 55905
- Recruiting
- Mid-Florida Hematology Oncology
-
Contact:
- Santosh Nair
-
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Georgia
-
Marietta, Georgia, United States, 30060
- Not yet recruiting
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
-
Contact:
- Steven McCune,
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Kentucky
-
Louisville, Kentucky, United States, 40241
- Not yet recruiting
- Norton Cancer Institute, Downtown, Multidisciplinary Clinic
-
Contact:
- Lye Adam
-
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Maryland
-
Bethesda, Maryland, United States, 20817
- Recruiting
- American Oncology Partners of Maryland, PA
-
Contact:
- Boccia Ralph
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Massachusetts
-
Boston, Massachusetts, United States, 461099
- Not yet recruiting
- Dana Farber Cancer Institute-Hematology/Oncology
-
Contact:
- Jacob Sands
-
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Michigan
-
Detroit, Michigan, United States, 48202
- Not yet recruiting
- Henry Ford Health System
-
Contact:
- Bindu Potugari,
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Detroit, Michigan, United States, 48201
- Not yet recruiting
- Karmanos Cancer Center
-
Contact:
- Mamdani Hirva
-
Grand Rapids, Michigan, United States, 49502
- Recruiting
- Cancer and Hematology Centers of Western Michigan
-
Contact:
- Yuanbin Chen
-
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Missouri
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Saint Louis, Missouri, United States, 63101
- Not yet recruiting
- Washington University School of Medicine - Siteman Cancer Center
-
Contact:
- Haobin Chen
-
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New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Not yet recruiting
- Dartmouth Hitchcock Medical Center
-
Contact:
- Charles Hsu
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 07101
- Not yet recruiting
- Rutgers Cancer Institute of New Jersey
-
Contact:
- Missak Haigentz
-
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New York
-
New York, New York, United States, 11776
- Not yet recruiting
- North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
-
Contact:
- Richard Zuniga
-
Stony Brook, New York, United States, 11794
- Not yet recruiting
- University of Stony Brook
-
Contact:
- Amna Sher
-
-
Ohio
-
Toledo, Ohio, United States, 97391
- Recruiting
- Toledo Clinic Cancer Center - Toledo
-
Contact:
- Rex Mowat
-
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Oregon
-
Eugene, Oregon, United States, 97401
- Not yet recruiting
- Oncology Associates of Oregon, P.C.
-
Contact:
- Bo Wang
-
Portland, Oregon, United States, 97239
- Not yet recruiting
- Oregon Health and Science University
-
Contact:
- Cetnar Jeremy
-
-
Texas
-
Houston, Texas, United States, 77090
- Recruiting
- Millennium Physicians - Oncology
-
Contact:
- Anirudha Dasgupta,
-
Tyler, Texas, United States, 97402
- Not yet recruiting
- Texas Oncology, P.A. - Oncology
-
Contact:
- Richards Donald
-
-
Virginia
-
Fairfax, Virginia, United States, 22030
- Not yet recruiting
- Virginia Cancer Specialists
-
Contact:
- Alexander Spira
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be enrolled:
- 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.
Exclusion Criteria:
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.
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo group C
Placebos for both tifcemalimab and toripalimab (IV)
|
every 3weeks
every 3weeks
|
|
Experimental: Experimental group A
Tifcemalimab (200 mg intravenous infusion [IV]) and toripalimab (240 mg IV)
|
200mg once every 3weeks
240mg once every 3 weeks
|
|
Experimental: Experimental group B
Placebo for tifcemalimab (IV) and toripalimab (240 mg IV)
|
240mg once every 3 weeks
every 3weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival (OS)
Time Frame: up to 3years
|
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
Time Frame: up to 3years
|
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)
Time Frame: up to 2years
|
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)
Time Frame: up to 2years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PFS
Time Frame: up to 2 years
|
To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by Investigator-assessed PFS
|
up to 2 years
|
|
PFS
Time Frame: up to 2years
|
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 Investigator-assessed PFS
|
up to 2years
|
|
1-year OS rate
Time Frame: up to 1year
|
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 1-year OS rate
|
up to 1year
|
|
2-year OS rate
Time Frame: up to 2 years
|
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 2-year OS rate
|
up to 2 years
|
|
objective response rate (ORR)
Time Frame: up to 2 years
|
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 ORR
|
up to 2 years
|
|
disease control rate (DCR)
Time Frame: up to 2 years
|
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 DCR
|
up to 2 years
|
|
duration of response (DoR)
Time Frame: up to 2years
|
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 DoR
|
up to 2years
|
|
1 year OS rate
Time Frame: up to 1 years
|
To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by 1-year OS rate
|
up to 1 years
|
|
2 year OS rate
Time Frame: up to 2 years
|
To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by 2-year OS rate
|
up to 2 years
|
|
ORR
Time Frame: up to 2 years
|
To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by ORR
|
up to 2 years
|
|
DCR
Time Frame: up to 2 years
|
To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by DCR
|
up to 2 years
|
|
DoR
Time Frame: up to 2 years
|
To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by DoR
|
up to 2 years
|
|
safety
Time Frame: up to 2 years
|
To compare and evaluate the safety of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by the incidence of adverse events (Percentage of participants with treatment-related adverse events as assessed by CTCAEv5.0.) and abnormal laboratory parameters.
|
up to 2 years
|
|
safety
Time Frame: up to 2 years
|
To compare and evaluate the safety of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by the incidence of adverse events (Percentage of participants with treatment-related adverse events as assessed by CTCAEv5.0.) and abnormal laboratory parameters.
|
up to 2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
correlation
Time Frame: up to 2 years
|
To evaluate the correlation between biomarkers(PD-L1) and efficacy(OS/PFS).
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2029
Study Registration Dates
First Submitted
October 9, 2023
First Submitted That Met QC Criteria
October 18, 2023
First Posted (Actual)
October 23, 2023
Study Record Updates
Last Update Posted (Actual)
June 21, 2024
Last Update Submitted That Met QC Criteria
June 19, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JS004-008-III-SCLC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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