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

Status: Recruiting
Location: See all (156) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Arkansas
Genesis Cancer and Blood Institute (Hot Springs, AR)
NOT_YET_RECRUITING
Hot Springs
Arizona
Banner MD Anderson Cancer Center
NOT_YET_RECRUITING
Goodyear
Banner University Medical Center
NOT_YET_RECRUITING
Tucson
California
SCRI Nashville
NOT_YET_RECRUITING
Davis
Los Angeles Hematology Oncology
NOT_YET_RECRUITING
Los Angeles
University of Southern California Norris Comprehensive Cancer
RECRUITING
Los Angeles
Zangmeister Cancer Center (Columbus, OH)
NOT_YET_RECRUITING
Los Angeles
Florida
Florida Cancer Specialists Pan Handle
NOT_YET_RECRUITING
Fort Myers
Florida Cancer Specialists South
NOT_YET_RECRUITING
Fort Myers
USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N
NOT_YET_RECRUITING
Miami
Mid-Florida Hematology Oncology
RECRUITING
Orange City
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
NOT_YET_RECRUITING
Marietta
Kentucky
Norton Cancer Institute, Downtown, Multidisciplinary Clinic
NOT_YET_RECRUITING
Louisville
Massachusetts
Dana Farber Cancer Institute-Hematology/Oncology
NOT_YET_RECRUITING
Boston
Maryland
American Oncology Partners of Maryland, PA
RECRUITING
Bethesda
Michigan
Henry Ford Health System
NOT_YET_RECRUITING
Detroit
Karmanos Cancer Center
NOT_YET_RECRUITING
Detroit
Cancer and Hematology Centers of Western Michigan
RECRUITING
Grand Rapids
Missouri
Washington University School of Medicine - Siteman Cancer Center
NOT_YET_RECRUITING
St Louis
New Hampshire
Dartmouth Hitchcock Medical Center
NOT_YET_RECRUITING
Lebanon
New Jersey
Rutgers Cancer Institute of New Jersey
NOT_YET_RECRUITING
New Brunswick
New York
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
NOT_YET_RECRUITING
New York
University of Stony Brook
NOT_YET_RECRUITING
Stony Brook
Ohio
Toledo Clinic Cancer Center - Toledo
RECRUITING
Toledo
Oregon
Oncology Associates Of Oregon, P.C.
NOT_YET_RECRUITING
Eugene
Oregon Health and Science University
NOT_YET_RECRUITING
Portland
Texas
Millennium Physicians - Oncology
RECRUITING
Houston
Texas Oncology, P.A. - Oncology
NOT_YET_RECRUITING
Tyler
Virginia
Virginia Cancer Specialists
NOT_YET_RECRUITING
Fairfax
Other Locations
Belgium
Algemeen Ziekenhuis Klina
NOT_YET_RECRUITING
Antwerp
Grand Hôpital de Charleroi - Site Notre-Dame
NOT_YET_RECRUITING
Charleroi
AZ Groeningen
NOT_YET_RECRUITING
Kortrijk
Jessa Ziekenhuis - Campus Virga Jesse
NOT_YET_RECRUITING
Limbourg
CHU UCL Namur - Site Sainte-Elisabeth
NOT_YET_RECRUITING
Namur
China
Anyang Tumor Hospital
RECRUITING
Anyang
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
Xiangya Hospital Central South University
RECRUITING
Changsha
Sichuan cancer hospital
NOT_YET_RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Peking University Shenzhen Hospital
NOT_YET_RECRUITING
Guangdong
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
No. 1 Bandong Road, Gongshu District, Hangzhou
RECRUITING
Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
The First Affiliated Hospital of Ustc
RECRUITING
Hefei
Henan Cancer Hospital
NOT_YET_RECRUITING
Henan
Shandong Cancer Hospital & Institute
RECRUITING
Jinan
Affiliated Hospital of Jining Medical University
NOT_YET_RECRUITING
Jining
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Liaoning cancer hospital
NOT_YET_RECRUITING
Shenyang
The First Hospital of China Medical University
RECRUITING
Shenyang
Shanxi Cancer hospital
RECRUITING
Taiyuan
Taizhou Hospital of Zhejiang Province
NOT_YET_RECRUITING
Taizhou
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Hubei Cancer Hospital (Hubei Cancer Research Institute)
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
General Hospital of Ningxia Medical University
RECRUITING
Yinchuan
France
Centre Hospitalier Universitaire D Angers
NOT_YET_RECRUITING
Angers
Institut Bergonie
NOT_YET_RECRUITING
Bordeaux
Centre Hospitalier Intercommunal De Créteil
NOT_YET_RECRUITING
Créteil
CHU de Grenoble
NOT_YET_RECRUITING
Grenoble
Centre Leon Berard - departement d'oncologie medicale
NOT_YET_RECRUITING
Lyon
Centre de Cancérologie du Grand Montpellier
NOT_YET_RECRUITING
Montpellier
Hopital Arnaud De Villeneuve - Oncologie/Pneumologie
NOT_YET_RECRUITING
Montpellier
Hopital Haut-Leveque - Maladies respiratoires
NOT_YET_RECRUITING
Pessac
Chu Hôpitaux De Rouen
NOT_YET_RECRUITING
Rouen
Institut de Cancérologie de l'Ouest (ICO)
NOT_YET_RECRUITING
Saint-herblain
Chru De Tours
NOT_YET_RECRUITING
Tours
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Georgia
ICO-Institute of Clinical Oncology - Hospital
RECRUITING
Tbilisi
ISR-GEO Med Res Clin Healthycore
RECRUITING
Tbilisi
LTD Israel-Georgian Medical Research Clinic Healthycore
RECRUITING
Tbilisi
Ltd New Hospitals
RECRUITING
Tbilisi
LTD New Hospitals
RECRUITING
Tbilisi
Multprofil Clinic Consilium Medulla
RECRUITING
Tbilisi
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
RECRUITING
Tbilisi
TIM - Tbilisi Institute of Medicine LTD
NOT_YET_RECRUITING
Tbilisi
Germany
Evangelische Lungenklinik Berlin
NOT_YET_RECRUITING
Berlin
Klinikum Esslingen GmbH Klinik für Kardiologie, Angiolgie und Pneumolgoie
NOT_YET_RECRUITING
Esslingen Am Neckar
Univeristätsklinikum Giessen und Marburg GmbH
NOT_YET_RECRUITING
Giessen
Klinikum Kassel GmbH Klinik für Onkologie uind Hämatologie- Onkologisches Studiensekretariat
NOT_YET_RECRUITING
Kassel
Gemeinschaftspraxis fuer Haematologie und Onkologie
NOT_YET_RECRUITING
Münster
Universitätsklinikum Regensburg
NOT_YET_RECRUITING
Regensburg
Italy
PO G. Rodolico, AOU Policlinico-Vittorio Emanuele Catania
NOT_YET_RECRUITING
Catania
Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS
NOT_YET_RECRUITING
Cesena
Azienda Ospedaliero Universitaria Careggi
NOT_YET_RECRUITING
Florence
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Mod
NOT_YET_RECRUITING
Modena
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
NOT_YET_RECRUITING
Napoli
Iov, Irccs
NOT_YET_RECRUITING
Padua
IRCCS Policlinico San Matteo, Università degli studi di Pavia
NOT_YET_RECRUITING
Pavia
AO S. Camillo-Forlanini
NOT_YET_RECRUITING
Roma
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS Feasibility survey: PO di Livorno, AUSL Toscana Nord Ovest, SST
NOT_YET_RECRUITING
Roma
Netherlands
Jeroen Bosch Ziekenhuis
NOT_YET_RECRUITING
's-hertogenbosch
Rijnstate Ziekenhuis
NOT_YET_RECRUITING
Arnhem
Erasmus Medisch Centrum
NOT_YET_RECRUITING
Rotterdam
Isala Klinieken Zwolle
NOT_YET_RECRUITING
Zwolle
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
NOT_YET_RECRUITING
Bialystok
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
NOT_YET_RECRUITING
Olsztyn
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. E. i J. Zeylandow
NOT_YET_RECRUITING
Poznan
Instytut Gruzlicy i Chorob Pluc
NOT_YET_RECRUITING
Warsaw
Republic of Korea
Chungbuk National University Hospital
NOT_YET_RECRUITING
Cheonju
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seongnam
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
NOT_YET_RECRUITING
Cluj-napoca
Medisprof
NOT_YET_RECRUITING
Cluj-napoca
Centrul de Oncologie Sf. Nectarie
NOT_YET_RECRUITING
Craiova
Oncolab
NOT_YET_RECRUITING
Craiova
Radiotherapy Center Cluj
NOT_YET_RECRUITING
Floreşti
Oncomed
NOT_YET_RECRUITING
Timișoara
Spain
Centro Oncológico de Galicia
NOT_YET_RECRUITING
A Coruña
Complexo Hospitalario Universitario A Coruña
NOT_YET_RECRUITING
A Coruña
Hospital Universitari Dexeus Grupo Quironsalud
NOT_YET_RECRUITING
Barcelona
C.H. Provincial de Castellón
NOT_YET_RECRUITING
Castellon
Complejo Hospitalario de Jaén
NOT_YET_RECRUITING
Jaén
Fundacion Jimenez Diaz
NOT_YET_RECRUITING
Madrid
Hospital Clínico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Complejo Hospitalario Universitario de Orense
NOT_YET_RECRUITING
Ourense
Hospital Universitario Central de Asturias
NOT_YET_RECRUITING
Oviedo
Hospital Universitario Donostia
NOT_YET_RECRUITING
San Sebastián
Hospital Universitario Virgen De La Macarena
NOT_YET_RECRUITING
Seville
Hospital Arnau De Vilanova De Valencia
NOT_YET_RECRUITING
Valencia
Hospital Universitario Y Politécnico La Fe
NOT_YET_RECRUITING
Valencia
H.C.U.Lozano Blesa
NOT_YET_RECRUITING
Zaragoza
Taiwan
No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.
RECRUITING
Kaohsiung City
China Medical University Hospital - Internal Medicine - Taichung
NOT_YET_RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
Chi Mei Hospital, Liouying - Department of Oncology
RECRUITING
Tainan City
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Hospital - Internal Medicine
NOT_YET_RECRUITING
Taipei
Taipei Medical University - Shuang Ho Hospital
RECRUITING
Taipei
Taipei Medical University - Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Medical University - WanFang Hospital - Hematology and Oncology
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei City
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Turkey
Ankara City Hospital
NOT_YET_RECRUITING
Ankara
Ankara Liv Hospital
NOT_YET_RECRUITING
Ankara
Gulhane Training and Research Hospital - Medical Oncology
NOT_YET_RECRUITING
Ankara
Memorial Ankara Hospital
RECRUITING
Ankara
Trakya University Medical Faculty
NOT_YET_RECRUITING
Edirne
Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology
NOT_YET_RECRUITING
Istanbul
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
NOT_YET_RECRUITING
Istanbul
Ege University Medical Faculty - Pulmonary
NOT_YET_RECRUITING
Izmir
İzmir Ekonomi Üniversitesi Medical Point İzmir Hastanesi
NOT_YET_RECRUITING
Izmir
Katip Celebi University Ataturk Research and Training Hospit
NOT_YET_RECRUITING
Izmir
Kocaeli University Research and Practice Hospital
RECRUITING
Kocaeli
Necmettin Erbakan University Meram
RECRUITING
Konya
Inonu University Turgut Ozal Medical Center
NOT_YET_RECRUITING
Malatya
Contact Information
Primary
kui zhang, Project Directer
kui_zhang@junshipharma.com
08618168028925
Backup
Kinga Kovacs, Senior Project Leader
Kinga.Kovacs@parexel.com
+ 31 6 45974346
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 756
Treatments
Experimental: Experimental group A
Tifcemalimab (200 mg intravenous infusion \[IV\]) and toripalimab (240 mg IV)
Experimental: Experimental group B
Placebo for tifcemalimab (IV) and toripalimab (240 mg IV)
Placebo_comparator: Placebo group C
Placebos for both tifcemalimab and toripalimab (IV)
Sponsors
Leads: Shanghai Junshi Bioscience Co., Ltd.

This content was sourced from clinicaltrials.gov