Trial Title:
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
Condition:
Limited-stage Small Cell Lung Cancer (LS-SCLC)
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Tifcemalimab injection
Description:
200mg once every 3weeks
Arm group label:
Experimental group A
Intervention type:
Drug
Intervention name:
toripalimab injection
Description:
240mg once every 3 weeks
Arm group label:
Experimental group A
Arm group label:
Experimental group B
Intervention type:
Drug
Intervention name:
Placebo for Tifcemalimab
Description:
every 3weeks
Arm group label:
Experimental group B
Arm group label:
Placebo group C
Intervention type:
Drug
Intervention name:
Placebo for toripalimab
Description:
every 3weeks
Arm group label:
Placebo group C
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be enrolled:
1. Male or female with age ≥ 18 years old at the time of informed consent.
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:
Patients will be excluded from the study if they meet any of the following criteria.
1. Mixed SCLC and non-small cell lung cancer (NSCLC).
2. Received sequential chemoradiotherapy for LS-SCLC.
3. 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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Goodyear
Zip:
85338
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jiaxin Niu
Facility:
Name:
Banner University Medical Center
Address:
City:
Tucson
Zip:
85713
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Charles Hsu
Facility:
Name:
Genesis Cancer and Blood Institute (Hot Springs, AR)
Address:
City:
Hot Springs
Zip:
05001
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Roy Timothy Webb
Facility:
Name:
SCRI Nashville
Address:
City:
Davis
Zip:
95616
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jhonson Melissa
Facility:
Name:
Zangmeister Cancer Center (Columbus, OH)
Address:
City:
Los Angeles
Zip:
43219
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jorge Rios-Perez
Facility:
Name:
Los Angeles Hematology Oncology
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Lasika Seneviratne,
Facility:
Name:
University of Southern California Norris Comprehensive Cancer
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Hsu,
Facility:
Name:
Florida Cancer Specialists Pan Handle
Address:
City:
Fort Myers
Zip:
32310
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jeffrey Bubis
Facility:
Name:
Florida Cancer Specialists South
Address:
City:
Fort Myers
Zip:
33908
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Alexander Glick
Facility:
Name:
USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N
Address:
City:
Miami
Zip:
33173
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Ikpeazu Chukwuemeka
Facility:
Name:
Mid-Florida Hematology Oncology
Address:
City:
Orange City
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Santosh Nair
Facility:
Name:
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Address:
City:
Marietta
Zip:
30060
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Steven McCune,
Facility:
Name:
Norton Cancer Institute, Downtown, Multidisciplinary Clinic
Address:
City:
Louisville
Zip:
40241
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Lye Adam
Facility:
Name:
American Oncology Partners of Maryland, PA
Address:
City:
Bethesda
Zip:
20817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boccia Ralph
Facility:
Name:
Dana Farber Cancer Institute-Hematology/Oncology
Address:
City:
Boston
Zip:
461099
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jacob Sands
Facility:
Name:
Karmanos Cancer Center
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Mamdani Hirva
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Bindu Potugari,
Facility:
Name:
Cancer and Hematology Centers of Western Michigan
Address:
City:
Grand Rapids
Zip:
49502
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yuanbin Chen
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63101
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Haobin Chen
Facility:
Name:
Dartmouth Hitchcock Medical Center
Address:
City:
Lebanon
Zip:
03756
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Charles Hsu
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
07101
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Missak Haigentz
Facility:
Name:
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
Address:
City:
New York
Zip:
11776
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Richard Zuniga
Facility:
Name:
University of Stony Brook
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Amna Sher
Facility:
Name:
Toledo Clinic Cancer Center - Toledo
Address:
City:
Toledo
Zip:
97391
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rex Mowat
Facility:
Name:
Oncology Associates Of Oregon, P.C.
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Bo Wang
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Cetnar Jeremy
Facility:
Name:
Millennium Physicians - Oncology
Address:
City:
Houston
Zip:
77090
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anirudha Dasgupta,
Facility:
Name:
Texas Oncology, P.A. - Oncology
Address:
City:
Tyler
Zip:
97402
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Richards Donald
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Alexander Spira
Facility:
Name:
Algemeen Ziekenhuis Klina
Address:
City:
Antwerpen
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Wim Demey
Facility:
Name:
Grand Hôpital de Charleroi - Site Notre-Dame
Address:
City:
Charleroi
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Colinet Benoit
Facility:
Name:
AZ Groeningen
Address:
City:
Kortrijk
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Sofie Derijcke
Facility:
Name:
Jessa Ziekenhuis - Campus Virga Jesse
Address:
City:
Limbourg
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Kristof Cuppens
Facility:
Name:
CHU UCL Namur - Site Sainte-Elisabeth
Address:
City:
Namur
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Jean-Charles Goeminne
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Yu
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Rongrong Zhou
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Anwen Liu
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Jin
Facility:
Name:
Shandong Cancer Hospital & Institute
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinming Yu, MD, PhD,
Phone:
86 13806406293
Email:
sdyujinming@126.com
Investigator:
Last name:
Jinming Yu, MD, PhD,
Email:
Principal Investigator
Facility:
Name:
Anyang Tumor Hospital
Address:
City:
Anyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Anping Zheng
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Anhui Shi
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhouguang Hui
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Cheng
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Wang
Facility:
Name:
Sichuan cancer hospital
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenxiu Yao
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Wang
Facility:
Name:
Peking University Shenzhen Hospital
Address:
City:
Guangdong
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yajie Liu
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Chen
Facility:
Name:
No. 1 Bandong Road, Gongshu District, Hangzhou
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongling Ji
Facility:
Name:
The Second Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Wen Li
Facility:
Name:
The First Affiliated Hospital of Ustc
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Dong Qian
Contact backup:
Last name:
Junqiang Zhang
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Henan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hong Ge
Facility:
Name:
Affiliated Hospital of Jining Medical University
Address:
City:
Jining
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shucheng Ye
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Longhua Sun
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Anwen Liu
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jing Wang
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ming Fan
Facility:
Name:
Liaoning cancer hospital
Address:
City:
Shenyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaoling Li
Facility:
Name:
Shanxi Cancer hospital
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Li
Facility:
Name:
Taizhou Hospital of Zhejiang Province
Address:
City:
Taizhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Dongqing Lv
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Lujun Zhao
Facility:
Name:
Hubei Cancer Hospital (Hubei Cancer Research Institute)
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Desheng Hu
Contact backup:
Last name:
Yi Peng
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Conghua Xie
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qin Lin
Facility:
Name:
General Hospital of Ningxia Medical University
Address:
City:
Yinchuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Ren Zhao
Facility:
Name:
Centre Hospitalier Universitaire D Angers
Address:
City:
Angers
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Youssef Oulkhouir
Facility:
Name:
Institut Bergonie
Address:
City:
Bordeaux
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sophie Cousin
Facility:
Name:
Centre Hospitalier Intercommunal De Créteil
Address:
City:
Créteil
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Isabelle Monnet
Facility:
Name:
CHU de Grenoble
Address:
City:
Grenoble
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Denis Moro-Sibilot
Facility:
Name:
Centre Leon Berard - departement d'oncologie medicale
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Maurice Perol
Facility:
Name:
Centre de Cancérologie du Grand Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Ivan Toledano
Facility:
Name:
Hopital Arnaud De Villeneuve - Oncologie/Pneumologie
Address:
City:
Montpellier
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jean-Louis Pujol
Facility:
Name:
Hopital Haut-Leveque - Maladies respiratoires
Address:
City:
Pessac
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Remi Veillon
Facility:
Name:
Chu Hôpitaux De Rouen
Address:
City:
Rouen
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Florian Guisier
Facility:
Name:
Institut de Cancérologie de l'Ouest (ICO)
Address:
City:
Saint-Herblain
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sandrine Hiret
Facility:
Name:
Chru De Tours
Address:
City:
Tours Cedex 9
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Eric Pichon
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Lavaud Pernelle
Facility:
Name:
"TIM - Tbilisi Institute of Medicine" LTD
Address:
City:
Tbilisi
Country:
Georgia
Status:
Not yet recruiting
Contact:
Last name:
Mariam Zhvania
Facility:
Name:
ICO-Institute of Clinical Oncology - Hospital
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Vladimer Kuchava
Facility:
Name:
ISR-GEO Med Res Clin Healthycore
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Ekaterine Arkania
Facility:
Name:
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Ekaterine Arkania
Facility:
Name:
LTD "New Hospitals"
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Davit Giorgadze
Facility:
Name:
Ltd New Hospitals
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Davit Giorgadze
Facility:
Name:
Multprofil Clinic Consilium Medulla
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Tsira Kortua
Facility:
Name:
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Miranda Gogishvili
Facility:
Name:
Evangelische Lungenklinik Berlin
Address:
City:
Berlin
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Christian Grohé
Facility:
Name:
Klinikum Esslingen GmbH Klinik für Kardiologie, Angiolgie und Pneumolgoie
Address:
City:
Esslingen
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Martin Faehling
Facility:
Name:
Univeristätsklinikum Giessen und Marburg GmbH
Address:
City:
Gießen
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Thomas Wehler
Facility:
Name:
Klinikum Kassel GmbH Klinik für Onkologie uind Hämatologie- Onkologisches Studiensekretariat
Address:
City:
Kassel
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Martin Wolf
Facility:
Name:
Gemeinschaftspraxis fuer Haematologie und Onkologie
Address:
City:
Münster
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Rüdiger Liersch
Facility:
Name:
Universitätsklinikum Regensburg
Address:
City:
Regensburg
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Christian Schulz
Facility:
Name:
PO G. Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Address:
City:
Catania
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Hector Jose Soto Parra
Facility:
Name:
Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS
Address:
City:
Cesena
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Angelo Delmonte
Facility:
Name:
Azienda Ospedaliero Universitaria Careggi
Address:
City:
Firenze
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Lorenzo Antonuzzo
Facility:
Name:
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Mod
Address:
City:
Modena
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Bertolini Federica
Facility:
Name:
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Address:
City:
Napoli
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Ferdinando Riccardi
Facility:
Name:
Iov, Irccs
Address:
City:
Padova
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Laura Bonnano
Facility:
Name:
IRCCS Policlinico San Matteo, Università degli studi di Pavia
Address:
City:
Pavia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Andrea Filippi
Facility:
Name:
AO S. Camillo-Forlanini
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Ricciardi Serena
Facility:
Name:
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS Feasibility survey: PO di Livorno, AUSL Toscana Nord Ovest, SST
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Federico Cappuzzo
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheonju
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Ki Hyeong Lee,
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Yu Jung 유정 Kim 김,
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Sun선, Min민 Lim임,
Facility:
Name:
Rijnstate Ziekenhuis
Address:
City:
Arnhem
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Claessens Niels
Facility:
Name:
Jeroen Bosch Ziekenhuis
Address:
City:
Herzogenbusch
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
van Veggel B.A.M.H. (Bianca)
Facility:
Name:
Erasmus Medisch Centrum
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Dumoulin Daphne
Facility:
Name:
Isala Klinieken Zwolle
Address:
City:
Zwolle
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Plomp Peter
Facility:
Name:
Uniwersytecki Szpital Kliniczny w Bialymstoku
Address:
City:
Białystok
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Robert Mroz
Facility:
Name:
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
Address:
City:
Olsztyn
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Sergiusz Nawrocki
Facility:
Name:
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. E. i J. Zeylandow
Address:
City:
Poznań
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Katarzyna Stencel
Facility:
Name:
Instytut Gruzlicy i Chorob Pluc
Address:
City:
Warszawa
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Mateusz Polaczek
Facility:
Name:
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Address:
City:
Cluj-Napoca
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Alina Simona Muntean
Facility:
Name:
Medisprof
Address:
City:
Cluj-Napoca
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Anghel Adrian Udrea
Facility:
Name:
Centrul de Oncologie Sf. Nectarie
Address:
City:
Craiova
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Michael Schenker
Facility:
Name:
Oncolab
Address:
City:
Craiova
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Dan Lungulescu
Facility:
Name:
Radiotherapy Center Cluj
Address:
City:
Floreşti
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Andrei Ungureanu
Facility:
Name:
Oncomed
Address:
City:
Timişoara
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Serban Mircea Negru
Facility:
Name:
Hospital Universitari Dexeus Grupo Quironsalud
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Ivana Gabriela Sullivan
Facility:
Name:
C.H. Provincial de Castellón
Address:
City:
Castellón De La Plana
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Alfredo Sánchez Hernández
Facility:
Name:
Centro Oncológico de Galicia
Address:
City:
Coruña
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Margarita Amenedo Gancedo
Facility:
Name:
Complexo Hospitalario Universitario A Coruña
Address:
City:
Coruña
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Maria Rosario Garcia Campelo
Facility:
Name:
Complejo Hospitalario de Jaén
Address:
City:
Jaén
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Ana Laura Ortega Granados
Facility:
Name:
Fundacion Jimenez Diaz
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Manuel Dómine Gómez
Facility:
Name:
Hospital Clínico San Carlos
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Jose González Larriba
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Javier de Castro Carpeño
Facility:
Name:
Complejo Hospitalario Universitario de Orense
Address:
City:
Orense
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Maria Areses Manrique
Facility:
Name:
Hospital Universitario Central de Asturias
Address:
City:
Oviedo
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Noemí Villanueva Palicio
Facility:
Name:
Hospital Universitario Donostia
Address:
City:
San Sebastián
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Ibone de Elejoste Echebarria
Facility:
Name:
Hospital Universitario Virgen De La Macarena
Address:
City:
Sevilla
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
David Vincente Baz
Facility:
Name:
Hospital Arnau De Vilanova De Valencia
Address:
City:
Valencia
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Javier Garde Noguera,
Facility:
Name:
Hospital Universitario Y Politécnico La Fe
Address:
City:
Valencia
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Oscar Juan Vidal
Facility:
Name:
H.C.U.Lozano Blesa
Address:
City:
Zaragoza
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Maria Dolores Isla Casado
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei city
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yuh-Min Chen
Facility:
Name:
No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chin-Chou 金洲 Wang 王
Facility:
Name:
China Medical University Hospital - Internal Medicine - Taichung
Address:
City:
Taichung
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Te-Chun 德椿 Hsia 夏
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Tsung-Ying 宗穎 Yang 楊
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan City
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chun Hui Lee
Facility:
Name:
Chi Mei Hospital, Liouying - Department of Oncology
Address:
City:
Tainan
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Wan-Chen婉真 Kao高
Facility:
Name:
National Taiwan University Hospital - Internal Medicine
Address:
City:
Taipei
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Chih-Hsin 志新 Yang 楊
Facility:
Name:
Taipei Medical University - Shuang Ho Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Kang-Yun 岡遠 Lee 李
Facility:
Name:
Taipei Medical University - Taipei Medical University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Shih-Hsin 世欣 Hsiao 蕭
Facility:
Name:
Taipei Medical University - WanFang Hospital - Hematology and Oncology
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Han-Lin 翰琳 Hsu 許
Facility:
Name:
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Address:
City:
Taoyuan
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chien-Ying 劍英 Liu 劉
Facility:
Name:
Ankara City Hospital
Address:
City:
Ankara
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Mehmet Sendur
Facility:
Name:
Ankara Liv Hospital
Address:
City:
Ankara
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Saadettin Kilickap
Facility:
Name:
Gulhane Training and Research Hospital - Medical Oncology
Address:
City:
Ankara
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Nuri Karadurmus
Facility:
Name:
Memorial Ankara Hospital
Address:
City:
Ankara
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Umut Demirici
Facility:
Name:
Trakya University Medical Faculty
Address:
City:
Edirne
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Muhammet Hacioglu
Facility:
Name:
Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology
Address:
City:
Istanbul
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Deniz Tural
Facility:
Name:
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
Address:
City:
Istanbul
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Mahmut Gumus
Facility:
Name:
Ege University Medical Faculty - Pulmonary
Address:
City:
İzmir
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Tuncay Goksel
Facility:
Name:
İzmir Ekonomi Üniversitesi Medical Point İzmir Hastanesi
Address:
City:
İzmir
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Arslan Cagatay
Facility:
Name:
Katip Celebi University Ataturk Research and Training Hospit
Address:
City:
İzmir
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Ahmet Alacacioglu
Facility:
Name:
Kocaeli University Research and Practice Hospital
Address:
City:
Kocaeli
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Devrim Cabuk
Facility:
Name:
Necmettin Erbakan University Meram
Address:
City:
Konya
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Mehmet Artac
Facility:
Name:
Inonu University Turgut Ozal Medical Center
Address:
City:
Malatya
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Hakan Harputluoglu
Start date:
November 15, 2023
Completion date:
July 31, 2029
Lead sponsor:
Agency:
Shanghai Junshi Bioscience Co., Ltd.
Agency class:
Other
Source:
Shanghai Junshi Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06095583