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)
NCT ID: NCT06095583
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
756 participants
INTERVENTIONAL
2023-11-15
2029-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental group A
Tifcemalimab (200 mg intravenous infusion \[IV\]) and toripalimab (240 mg IV)
Tifcemalimab injection
200mg once every 3weeks
toripalimab injection
240mg once every 3 weeks
Experimental group B
Placebo for tifcemalimab (IV) and toripalimab (240 mg IV)
toripalimab injection
240mg once every 3 weeks
Placebo for Tifcemalimab
every 3weeks
Placebo group C
Placebos for both tifcemalimab and toripalimab (IV)
Placebo for Tifcemalimab
every 3weeks
Placebo for toripalimab
every 3weeks
Interventions
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Tifcemalimab injection
200mg once every 3weeks
toripalimab injection
240mg once every 3 weeks
Placebo for Tifcemalimab
every 3weeks
Placebo for toripalimab
every 3weeks
Eligibility Criteria
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Inclusion Criteria
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
1. Mixed SCLC and non-small cell lung cancer (NSCLC).
2. Received sequential chemoradiotherapy for LS-SCLC.
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.
18 Years
ALL
No
Sponsors
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Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
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Locations
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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
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 City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , 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)
Countries
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Central Contacts
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Facility Contacts
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Jiaxin Niu
Role: primary
Charles Hsu
Role: primary
Roy Timothy Webb
Role: primary
Jhonson Melissa
Role: primary
Jorge Rios-Perez
Role: primary
Lasika Seneviratne,
Role: primary
Robert Hsu,
Role: primary
Jeffrey Bubis
Role: primary
Alexander Glick
Role: primary
Ikpeazu Chukwuemeka
Role: primary
Santosh Nair
Role: primary
Steven McCune,
Role: primary
Lye Adam
Role: primary
Boccia Ralph
Role: primary
Jacob Sands
Role: primary
Mamdani Hirva
Role: primary
Bindu Potugari,
Role: primary
Yuanbin Chen
Role: primary
Haobin Chen
Role: primary
Charles Hsu
Role: primary
Missak Haigentz
Role: primary
Richard Zuniga
Role: primary
Amna Sher
Role: primary
Rex Mowat
Role: primary
Bo Wang
Role: primary
Cetnar Jeremy
Role: primary
Anirudha Dasgupta,
Role: primary
Richards Donald
Role: primary
Alexander Spira
Role: primary
Wim Demey
Role: primary
Colinet Benoit
Role: primary
Sofie Derijcke
Role: primary
Kristof Cuppens
Role: primary
Jean-Charles Goeminne
Role: primary
Yan Yu
Role: primary
Rongrong Zhou
Role: primary
Anwen Liu
Role: primary
Bo Jin
Role: primary
Anping Zheng
Role: primary
Anhui Shi
Role: primary
Zhouguang Hui
Role: primary
Ying Cheng
Role: primary
Hui Wang
Role: primary
Wenxiu Yao
Role: primary
Ying Wang
Role: primary
Yajie Liu
Role: primary
Ming Chen
Role: primary
Yongling Ji
Role: primary
Wen Li
Role: primary
Dong Qian
Role: primary
Junqiang Zhang
Role: backup
Hong Ge
Role: primary
Shucheng Ye
Role: primary
Longhua Sun
Role: primary
Anwen Liu
Role: primary
Jing Wang
Role: primary
Ming Fan
Role: primary
Xiaoling Li
Role: primary
Jie Li
Role: primary
Dongqing Lv
Role: primary
Lujun Zhao
Role: primary
Desheng Hu
Role: primary
Yi Peng
Role: backup
Conghua Xie
Role: primary
Qin Lin
Role: primary
Ren Zhao
Role: primary
Youssef Oulkhouir
Role: primary
Sophie Cousin
Role: primary
Isabelle Monnet
Role: primary
Denis Moro-Sibilot
Role: primary
Maurice Perol
Role: primary
Ivan Toledano
Role: primary
Jean-Louis Pujol
Role: primary
Remi Veillon
Role: primary
Florian Guisier
Role: primary
Sandrine Hiret
Role: primary
Eric Pichon
Role: primary
Lavaud Pernelle
Role: primary
Mariam Zhvania
Role: primary
Vladimer Kuchava
Role: primary
Ekaterine Arkania
Role: primary
Ekaterine Arkania
Role: primary
Davit Giorgadze
Role: primary
Davit Giorgadze
Role: primary
Tsira Kortua
Role: primary
Miranda Gogishvili
Role: primary
Christian Grohé
Role: primary
Martin Faehling
Role: primary
Thomas Wehler
Role: primary
Martin Wolf
Role: primary
Rüdiger Liersch
Role: primary
Christian Schulz
Role: primary
Hector Jose Soto Parra
Role: primary
Angelo Delmonte
Role: primary
Lorenzo Antonuzzo
Role: primary
Bertolini Federica
Role: primary
Ferdinando Riccardi
Role: primary
Laura Bonnano
Role: primary
Andrea Filippi
Role: primary
Ricciardi Serena
Role: primary
Federico Cappuzzo
Role: primary
van Veggel B.A.M.H. (Bianca)
Role: primary
Claessens Niels
Role: primary
Dumoulin Daphne
Role: primary
Plomp Peter
Role: primary
Robert Mroz
Role: primary
Sergiusz Nawrocki
Role: primary
Katarzyna Stencel
Role: primary
Mateusz Polaczek
Role: primary
Alina Simona Muntean
Role: primary
Anghel Adrian Udrea
Role: primary
Michael Schenker
Role: primary
Dan Lungulescu
Role: primary
Andrei Ungureanu
Role: primary
Serban Mircea Negru
Role: primary
Ki Hyeong Lee,
Role: primary
Yu Jung 유정 Kim 김,
Role: primary
Sun선, Min민 Lim임,
Role: primary
Margarita Amenedo Gancedo
Role: primary
Maria Rosario Garcia Campelo
Role: primary
Ivana Gabriela Sullivan
Role: primary
Alfredo Sánchez Hernández
Role: primary
Ana Laura Ortega Granados
Role: primary
Manuel Dómine Gómez
Role: primary
Jose González Larriba
Role: primary
Javier de Castro Carpeño
Role: primary
Maria Areses Manrique
Role: primary
Noemí Villanueva Palicio
Role: primary
Ibone de Elejoste Echebarria
Role: primary
David Vincente Baz
Role: primary
Javier Garde Noguera,
Role: primary
Oscar Juan Vidal
Role: primary
Maria Dolores Isla Casado
Role: primary
Yuh-Min Chen
Role: primary
Chin-Chou 金洲 Wang 王
Role: primary
Te-Chun 德椿 Hsia 夏
Role: primary
Tsung-Ying 宗穎 Yang 楊
Role: primary
Wan-Chen婉真 Kao高
Role: primary
Chun Hui Lee
Role: primary
Chih-Hsin 志新 Yang 楊
Role: primary
Kang-Yun 岡遠 Lee 李
Role: primary
Shih-Hsin 世欣 Hsiao 蕭
Role: primary
Han-Lin 翰琳 Hsu 許
Role: primary
Chien-Ying 劍英 Liu 劉
Role: primary
Mehmet Sendur
Role: primary
Saadettin Kilickap
Role: primary
Nuri Karadurmus
Role: primary
Umut Demirici
Role: primary
Muhammet Hacioglu
Role: primary
Deniz Tural
Role: primary
Mahmut Gumus
Role: primary
Tuncay Goksel
Role: primary
Arslan Cagatay
Role: primary
Ahmet Alacacioglu
Role: primary
Devrim Cabuk
Role: primary
Mehmet Artac
Role: primary
Hakan Harputluoglu
Role: primary
Other Identifiers
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JS004-008-III-SCLC
Identifier Type: -
Identifier Source: org_study_id
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