Trial Title:
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
NCT ID:
NCT05555732
Condition:
Metastatic Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pembrolizumab
Pemetrexed
Conditions: Keywords:
Metastatic Non Small Cell Lung Cancer
Advanced Non Small Cell Lung Cancer
Datopotamab Deruxtecan (Dato-DXd)
Pembrolizumab
Pemetrexed
Tropion-Lung07
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Datopotamab Deruxtecan
Description:
Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of
each 21-day cycle.
Arm group label:
Dato-DXd + Pembrolizumab
Arm group label:
Dato-DXd + Pembrolizumab + Platinum Chemotherapy
Other name:
Dato-DXd
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1
of each 21-day cycle.
Arm group label:
Dato-DXd + Pembrolizumab
Arm group label:
Dato-DXd + Pembrolizumab + Platinum Chemotherapy
Arm group label:
Pembrolizumab + Pemetrexed + Platinum Chemotherapy
Other name:
KEYTRUDA®
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of
each 21-day cycle.
Arm group label:
Pembrolizumab + Pemetrexed + Platinum Chemotherapy
Other name:
Alimta
Other name:
Pemfexy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of
each 21-day cycle for up to 4 cycles.
Arm group label:
Dato-DXd + Pembrolizumab + Platinum Chemotherapy
Arm group label:
Pembrolizumab + Pemetrexed + Platinum Chemotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of
each 21-day cycle for up to 4 cycles.
Arm group label:
Dato-DXd + Pembrolizumab + Platinum Chemotherapy
Arm group label:
Pembrolizumab + Pemetrexed + Platinum Chemotherapy
Summary:
This study is designed to assess the efficacy and safety of datopotamab deruxtecan
(Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with
pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced
or metastatic non-squamous non-small cell lung cancer (NSCLC).
Detailed description:
The primary objectives of the study are Progression Free Survival (PFS) and Overall
Survival (OS) as first line therapy in participants with programmed death-ligand 1
(PD-L1) TPS <50% and advanced or metastatic NSCLC without actionable genomic
alternations.
Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus
pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus
pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at
investigator discretion. The study will be divided into three periods: Screening Period
(including tissue screening), Treatment Period, and Follow-up Period.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Sign and date the Main ICF, prior to the start of any study- specific qualification
procedures. Is willing and able to comply with scheduled visits, drug administration
plan, laboratory tests, other study procedures, and study restrictions.
2. Adults ≥18 at the time the Main ICF is signed. (Follow local regulatory requirements
if the legal age of adult voluntary consent for study participation is >18 years
old).
3. Has tumor with PD-L1 TPS <50% as determined by PD-L1 IHC 22C3 pharmDx assay by
central testing (minimum of six slides). PD-L1 expression results available at the
same central laboratory from screening for the purpose of entry into another
Dato-DXd study may be used for tissue screening purposes in this study as long as
the subject has not been randomized/enrolled in the other study.
4. Has provided a formalin-fixed tumor tissue sample (minimum of 4 × 4-micron sections
or block equivalent) for the measurement of TROP2 protein expression and for the
assessment of other exploratory biomarkers. This tissue requirement is in addition
to the tissue required for PD-L1 testing for tissue screening purposes. If a
documented law or regulation prohibits (or does not approve) sample collection, then
such sample will not be collected, and the subject is still eligible for the study.
5. Has not been treated with systemic anticancer therapy for advanced or metastatic
non-squamous NSCLC. Subjects who received adjuvant or neoadjuvant therapy other than
those listed in the exclusion criteria are eligible if the adjuvant/ neoadjuvant
therapy was completed at least 6 months prior to the diagnosis of
advanced/metastatic disease and should not have progressed on or within the 6 months
of completion.
6. Has measurable disease based on local imaging assessment using RECIST v1.1;
radiographic tumor assessment must be performed within 28 days before randomization.
Key Exclusion Criteria:
1. Has received prior systemic treatment for advanced/metastatic NSCLC.
2. Has received prior treatment with any of the following, including in the
adjuvant/neoadjuvant setting (for NSCLC):
1. Any agent, including an ADC, containing a chemotherapeutic agent targeting
topoisomerase I
2. TROP2-targeted therapy
3. Any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to
another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
4. Any other ICIs Subjects who received adjuvant or neoadjuvant therapy OTHER than
those listed above are eligible if the adjuvant/neoadjuvant therapy was
completed at least 6 months prior to the diagnosis of advanced or metastatic
disease.
3. Has received a live vaccine within 30 days prior to the first dose of study
treatment.
Examples of live vaccines include, but are not limited to, the following: measles,
mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for
injection are generally killed virus vaccines and are allowed; however, intranasal
influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
For any subject receiving an approved severe acute respiratory syndrome
coronavirus-2 (SARS-CoV-2) vaccine, please follow the vaccine label and/or local
guidance. The vaccine manufacturer and the date of administration should be recorded
on the electronic case report form (Concomitant Medications page), as should any AEs
relating to the vaccine (including hypersensitivity or allergies). Note: Any
licensed SARS-CoV2 vaccine (including those authorized for emergency use) in a
particular country is allowed in the study as long as the vaccine is an mRNA
vaccine, replication-incompetent adenoviral vaccine, or inactivated vaccine. Such
vaccines will be treated just as any other concomitant therapy.
Investigational vaccines (ie, those not licensed or authorized for emergency use)
are not allowed.
4. Has spinal cord compression or clinically active untreated CNS metastases and/or
carcinomatous meningitis. Subjects with previously treated brain metastases may
participate provided they are radiologically stable (ie, without evidence of
progression) for at least 2 weeks by repeat imaging (Note: Repeat imaging should be
performed during study screening), clinically stable, and without requirement of
steroid treatment for at least 7 days before the first dose of study drug. Note: A
contrasted computed tomography (CT) scan or magnetic resonance imaging (MRI) scan of
the brain at baseline (MRI with contrast preferred) is required for all subjects.
For those subjects in whom CNS metastases are first discovered at the time of
screening, the treating investigator must delay of study treatment to document
stability of CNS metastases with repeat imaging at least 2 weeks later (in which
case, repeat of all screening activity may be required).
5. Has uncontrolled or significant cardiovascular disease not controlled by maximal
medical therapy, including:
1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF)
interval >470 msec regardless of sex (based on the 12-lead electrocardiogram
[ECG] performed at screening).
2. Myocardial infarction within 6 months prior to Cycle 1 Day 1.
3. History of a serious cardiac arrhythmia requiring treatment
4. Uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.
5. Left ventricular ejection fraction (LVEF) <50% by echocardiogram (ECHO) or
multigated acquisition (MUGA) scan within 28 days before randomization.
6. New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) at
screening. Subjects with a history of Class II to IV CHF prior to screening,
must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA
scan within 28 days before randomization) in order to be eligible.
7. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or
diastolic blood pressure >110 mmHg within 28 days before randomization that is
not resolved despite maximal medical therapy).
6. Clinically severe pulmonary compromise as judged by the investigator resulting from
intercurrent pulmonary illnesses including, but not limited to, any underlying
pulmonary disorder (eg, pulmonary emboli diagnosed within 3 months of Cycle 1 Day 1,
severe asthma, severe chronic obstructive pulmonary disease, restrictive lung
disease, pleural effusion, etc) or any autoimmune, connective tissue or inflammatory
disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome,
sarcoidosis, etc), or prior complete pneumonectomy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern Cancer Center Pc
Address:
City:
Daphne
Zip:
36526
Country:
United States
Status:
Recruiting
Facility:
Name:
Ironwood Cancer and Research Centers
Address:
City:
Chandler
Zip:
85224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Arizona Oncology Associates, Pc - Nahoa
Address:
City:
Prescott Valley
Zip:
86314
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Blood and Cancer Center
Address:
City:
Bakersfield
Zip:
93309
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Hoag Memorial Hospital Prebyterian
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Compassionate Cancer Care Medical Group
Address:
City:
Riverside
Zip:
92501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Sansum Clinic
Address:
City:
Santa Barbara
Zip:
93105
Country:
United States
Status:
Recruiting
Facility:
Name:
UCHealth Memorial Hospital
Address:
City:
Colorado Springs
Zip:
80909
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Florida Cancer Specialists - South
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Specialist of North Florida
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Cancer Care Centers of Brevard, Inc.
Address:
City:
Palm Bay
Zip:
32901
Country:
United States
Status:
Recruiting
Facility:
Name:
Woodlands Medical Specialists, Pa
Address:
City:
Pensacola
Zip:
32503
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists-North
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Status:
Recruiting
Facility:
Name:
Emory University - Winship Cancer Institute Wci
Address:
City:
Atlanta
Zip:
30322-1013
Country:
United States
Status:
Recruiting
Facility:
Name:
Illinois Cancer Specialists
Address:
City:
Niles
Zip:
60714
Country:
United States
Status:
Recruiting
Facility:
Name:
American Oncology Partners of Maryland
Address:
City:
Bethesda
Zip:
20817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Maryland Oncology Heamtology P.A.
Address:
City:
Columbia
Zip:
21044
Country:
United States
Status:
Recruiting
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute; Inv Drg Svc Pharm
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute At St. Elizabeth'S Medical Center
Address:
City:
Brighton
Zip:
02135
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Brigham Cancer Center
Address:
City:
Foxboro
Zip:
02035
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber At Milford Regional Cancer Center
Address:
City:
Milford
Zip:
01757
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber/Bwcc in Affiliation With South Shore Hospital
Address:
City:
South Weymouth
Zip:
02190
Country:
United States
Status:
Recruiting
Facility:
Name:
Astera Cancer Care
Address:
City:
East Brunswick
Zip:
08816
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Regional Cancer Care Associates LLC
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists - Bronx
Address:
City:
Bronx
Zip:
10469
Country:
United States
Status:
Recruiting
Facility:
Name:
North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists- New Hyde Park
Address:
City:
New Hyde Park
Zip:
11042
Country:
United States
Status:
Recruiting
Facility:
Name:
North Shore Hematology Oncology Associates
Address:
City:
Patchogue
Zip:
11772
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
Address:
City:
Port Jefferson Station
Zip:
11776
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Texas Oncology, P.A.
Address:
City:
McAllen
Zip:
78503
Country:
United States
Status:
Recruiting
Facility:
Name:
Ut Health San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology, P.A.
Address:
City:
Sugar Land
Zip:
77479
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology-Tyler
Address:
City:
Tyler
Zip:
75702
Country:
United States
Status:
Recruiting
Facility:
Name:
Utah Cancer Specialists IHO Corp
Address:
City:
Salt Lake City
Zip:
84106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Providence Regional Cancer System
Address:
City:
Lacey
Zip:
98503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
VA Puget Sound Health Care System
Address:
City:
Seattle
Zip:
98108
Country:
United States
Status:
Recruiting
Facility:
Name:
Instituto Alexander Fleming
Address:
City:
Ciudad Autonoma de Buenos Aires
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Fundacion CENIT para la investigacion en Neurociencias
Address:
City:
Ciudad Autonoma de Buenos Aire
Zip:
1125
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Hospital de La Comunidad
Address:
City:
Mar del Plata
Zip:
7600
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Centro de Investigacion Pergamino Sa
Address:
City:
Pergamino
Zip:
B2700
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Instituto de Oncologia de Rosario
Address:
City:
Rosario
Zip:
2000DSK
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Sanatorio Parque
Address:
City:
Rosario
Zip:
S2000DSV
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Centro Polivalente de Asistencia E Investigacion Clinica Cer San Juan
Address:
City:
San Juan
Zip:
5400
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Centro de Investigaciones Clinicas. Clinica Viedma S.A.
Address:
City:
Viedma
Zip:
8500
Country:
Argentina
Status:
Recruiting
Facility:
Name:
CRSA/ St Andrews Hospital
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Flinders Medical Centre (Fmc)
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Facility:
Name:
PSEHOG (Peninsula and South Eastern Haematology and Oncology Group)
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Southern Medical Day Care Centre
Address:
City:
Wollongong
Zip:
2500
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Woolloongabba
Zip:
QLD 4102
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Landeskrankenhaus Feldkirch
Address:
City:
Feldkirch
Zip:
6800
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Klinikum Klagenfurt Pulmologie
Address:
City:
Klagenfurt
Zip:
9020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Arl Landsteiner Institut Fã¼R Lungenforschung Und Pneumologische Onkologie C/O Klinik Floridsdorf
Address:
City:
Vienna
Zip:
1210
Country:
Austria
Status:
Recruiting
Facility:
Name:
Az Maria Middelares - Campus Maria Middelares
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Centre hospitalier Jolimont-Lobbes
Address:
City:
Haine Saint-Paul
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Cliniques Saint Pierre Ottignies (CSPO)
Address:
City:
Ottignies
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Az Nikolaas
Address:
City:
Sint-Niklaas
Zip:
9100
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Personal Oncologia de Precisao - Cenantron
Address:
City:
Belo Horizonte
Zip:
30130 090
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundaco Universidade de Caxias Do Sul- Instituto de Pesquisas Em Saude Ips-Ucs
Address:
City:
Caxias do Sul
Zip:
95070-560
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Erasto Gaertner
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Address:
City:
Ijui
Zip:
98700-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Clínica de Neoplasias Litoral Ltda
Address:
City:
ItajaĂ-
Zip:
88301-220
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Clnica Lacks
Address:
City:
Pelotas
Zip:
96020-080
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Santa Casa de Misericordia de Porto Alegre
Address:
City:
Porto Alegre
Zip:
90050-170
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto Nacional de Că'Ncer - Inca
Address:
City:
Rio de Janeiro
Zip:
20231-050
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Centro de Estudos E Pesquisa de Hematologia E Oncologia - Cepho
Address:
City:
Santo Andre
Zip:
09060-870
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto de Ensino E Pesquisa Sao Lucas
Address:
City:
Sao Paulo
Zip:
01236-030
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto Do Cancer Brasil - Unidade Taubate
Address:
City:
Taubate
Zip:
12030-200
Country:
Brazil
Status:
Recruiting
Facility:
Name:
CHU de Quebec -Universite Laval Hopital de L'Enfant-Jesus
Address:
City:
Quebec City
Zip:
G1J 1Z4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Centro de Estudios Clinicos Saga Spa
Address:
City:
Santiago de Chile
Zip:
7500653
Country:
Chile
Status:
Recruiting
Facility:
Name:
ONCOVIDA
Address:
City:
Santiago
Zip:
7500000
Country:
Chile
Status:
Recruiting
Facility:
Name:
Centro de Investigaciones Clinicas Vina Del Mar
Address:
City:
ViĂąa Del Mar
Zip:
254-0488
Country:
Chile
Status:
Recruiting
Facility:
Name:
Peking University Cancer Hospital Beijing Cancer Hospital Beijing Institute For Cancer Research
Address:
City:
Beijing Sheng
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Peking University Peoples Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Facility:
Name:
Cangzhou Peoples Hospital
Address:
City:
Cangzhou
Zip:
061000
Country:
China
Status:
Recruiting
Facility:
Name:
First Affiliated Hospital of Medical College of Jilin University
Address:
City:
Changchun
Zip:
130000
Country:
China
Status:
Recruiting
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130000
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410011
Country:
China
Status:
Recruiting
Facility:
Name:
University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute SIC
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Medical University - Union Hospital Foochow Christian Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Cancer Hospital and Insititute of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510095
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Facility:
Name:
Run Run Shaw Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of College of Medicine Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Facility:
Name:
An Hui Cancer Hospital
Address:
City:
Hefei
Zip:
230031
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Inner Mongolia Medical University- the Affiliated Hospital
Address:
City:
Hohhot
Zip:
010050
Country:
China
Status:
Recruiting
Facility:
Name:
Jiamusi Cancer Hospital
Address:
City:
Jiamusi
Zip:
154007
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Zip:
276000
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Facility:
Name:
Zhongda Hospital, Southeast University
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200052
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110042
Country:
China
Status:
Recruiting
Facility:
Name:
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
The First Affiliate Hospital of Xi'An Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Facility:
Name:
Xiangyang Central Hospital
Address:
City:
Xianyang
Zip:
441021
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hosptial of Xinjiang Medical University
Address:
City:
Ürümqi
Zip:
830000
Country:
China
Status:
Recruiting
Contact:
Last name:
Principal Investiagator
Facility:
Name:
Chu de Bordeaux - Hopital Saint Andre
Address:
City:
Bordeaux
Zip:
33075
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire, CHU, de Poitiers
Address:
City:
France
Zip:
86021
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Facility:
Name:
Aphm - Hopital Nord
Address:
City:
Marseille Cedex 20
Zip:
13015
Country:
France
Status:
Recruiting
Facility:
Name:
Chu de Montpellier
Address:
City:
Montpellier Cedex 5
Zip:
34295
Country:
France
Status:
Recruiting
Facility:
Name:
Chu de Nantes
Address:
City:
Nantes
Zip:
44000
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Prive Du Confluent
Address:
City:
Nantes
Zip:
44277
Country:
France
Status:
Recruiting
Facility:
Name:
Tenon Hospital
Address:
City:
Paris
Zip:
75020
Country:
France
Status:
Recruiting
Facility:
Name:
Hôpital Foch
Address:
City:
Suresnes
Zip:
92150
Country:
France
Status:
Recruiting
Facility:
Name:
Evangelische Lungenklinik Berlin
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Chemnitz
Address:
City:
Chemnitz
Zip:
9116
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Esslingen Gmbh
Address:
City:
Esslingen
Zip:
73730
Country:
Germany
Status:
Recruiting
Facility:
Name:
University Hospital Giessen, ZIM IV
Address:
City:
Giessen
Country:
Germany
Status:
Recruiting
Facility:
Name:
External pharmacy Fortuna Herstellung GmbH of main site Universitaetsmedizin Mannheim
Address:
City:
Mannheim
Country:
Germany
Status:
Recruiting
Facility:
Name:
University Hospital Mă Nster
Address:
City:
Muenster
Zip:
48149
Country:
Germany
Status:
Recruiting
Facility:
Name:
Ludwig-Maximilians University Hospital of Munich
Address:
City:
Munich
Zip:
80336
Country:
Germany
Status:
Recruiting
Facility:
Name:
Sotiria General Hospital of Chest Diseases
Address:
City:
Athens
Zip:
11527
Country:
Greece
Status:
Recruiting
Facility:
Name:
University General Hospital of Heraklion
Address:
City:
Heraklion
Zip:
71110
Country:
Greece
Status:
Recruiting
Facility:
Name:
University Hospital of Ioannina Uhi
Address:
City:
Ioannina
Zip:
45500
Country:
Greece
Status:
Recruiting
Facility:
Name:
Metropolitan Hospital
Address:
City:
Neo Faliro
Zip:
18547
Country:
Greece
Status:
Recruiting
Facility:
Name:
Bioclinic Thessaloniki (Galinos Clinic)
Address:
City:
Thessalonki
Zip:
54622
Country:
Greece
Status:
Recruiting
Facility:
Name:
Prince of Wales Hospital / The Chinese University of Hong Kong
Address:
City:
Hong Kong
Zip:
99999
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Tuen Mun Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Queen Mary Hospital
Address:
City:
Pok Fu Lam
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
National Koranyi Institute For Pulmonology
Address:
City:
Budapest
Zip:
1121
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Veszprem Megyei Tudogyogyintezet Farkasgyepu
Address:
City:
Farkasgyepu
Zip:
8582
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Bkmk Hospital
Address:
City:
KecskemĂŠt
Zip:
6000
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Fejer Megyei Szent Gyorgy Korhaz Pulmonologiai Osztaly
Address:
City:
Szekesfehervar
Zip:
8000
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Hetenyi G Korhaz, Onkologiai Kozpont
Address:
City:
Szolnok
Zip:
5007
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Istituto Di Candiolo Irccs
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale San Luca
Address:
City:
Lucca
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Status:
Recruiting
Facility:
Name:
IFO Regina Elena
Address:
City:
Rome
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale S. Maria Della Misericordia
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Asst Sette Laghi
Address:
City:
Varese
Zip:
21100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Roma Crc - Centro Ricerche Clinich
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Facility:
Name:
NHO Shikoku Cancer Center
Address:
City:
Ehime
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Kurume University Hospital
Address:
City:
Fukoka
Zip:
830-0011
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Kyushu Cancer Center
Address:
City:
Fukuoka
Zip:
811-1395
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Kyushu University Hospital
Address:
City:
Fukuoka
Zip:
812-0054
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Teine Keijinkai Hospital
Address:
City:
Hokkaido
Zip:
006-0811
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Hyogo Medical University Hospital
Address:
City:
Hyogo
Zip:
663-8501
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kanazawa University Hospital
Address:
City:
Ishikawa
Zip:
920-8641
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Kanagawa
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Kitasato University hospital
Address:
City:
Kanagawa
Zip:
252-0375
Country:
Japan
Status:
Recruiting
Facility:
Name:
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Address:
City:
Kumamoto
Zip:
861-4193
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
University Hospital Kyoto Prefectual University of Medicine
Address:
City:
Kyoto
Zip:
602-8566
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Matsusaka Municipal Hospital
Address:
City:
Mie
Zip:
515-8544
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Sendai Kousei Hospital
Address:
City:
Miyagi
Zip:
981-0914
Country:
Japan
Status:
Recruiting
Facility:
Name:
Niigata Cancer Center Hospital
Address:
City:
Niigata
Zip:
951-8566
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka
Zip:
540-0008
Country:
Japan
Status:
Recruiting
Facility:
Name:
Osaka Toneyama Medical Center
Address:
City:
Osaka
Zip:
560-8552
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Kansai Medical University Hospital
Address:
City:
Osaka
Zip:
573-1191
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
NHO Kinki-Chuo Chest Medical Center
Address:
City:
Osaka
Zip:
591-8555
Country:
Japan
Status:
Recruiting
Facility:
Name:
Dokkyo Medical University Hospital
Address:
City:
Tochigi
Zip:
321-0293
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address:
City:
Tokyo
Zip:
113-0021
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Juntendo University Hospital
Address:
City:
Tokyo
Zip:
113-8431
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Tokyo
Zip:
135-0063
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Toho University Omori Medical Center
Address:
City:
Tokyo
Zip:
143-8540
Country:
Japan
Status:
Recruiting
Facility:
Name:
Iwakuni Clinical Center
Address:
City:
Yamaguchi
Zip:
740-8510
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Yamaguchi-Ube Medical Center
Address:
City:
Yamaguchi
Zip:
755-0241
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Yamanashi Prefectural Central Hospital
Address:
City:
Yamanashi
Zip:
400-8506
Country:
Japan
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongjusi
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Kyungpook National University Chilgok Hospital
Address:
City:
Daegu
Zip:
41404
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Samsung Medical Center
Address:
City:
Gangnam-Gu
Zip:
6351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Principal Invesigator
Facility:
Name:
Gyeongsang National University Hospital
Address:
City:
Jinju-si Gyeongsangnam-do
Zip:
52727
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Yonsei University Health System - Severance Hospital
Address:
City:
Seoul
Zip:
3722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Cryptex Investigacion Clinica Sa de Cv
Address:
City:
Cuauhtemoc
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Hospital Civil de Guadalajara Fray Antonio Alcalde
Address:
City:
Guadalajara
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Centro de Investigacion Clinica de Oaxaca CICLO
Address:
City:
Oaxaca
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Amphia Ziekenhuis
Address:
City:
Breda
Zip:
4819 EV
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Zip:
2333ZA
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Jeroen Bosch Ziekenhuis Jbz
Address:
City:
s-Hertogenbosch
Zip:
5200 ME
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
II Klinika Chorob Pluc i Gruzlicy
Address:
City:
Bialystok
Zip:
15-540
Country:
Poland
Status:
Recruiting
Facility:
Name:
Centrum Terapii Wspolczesnej
Address:
City:
Lodz
Zip:
90-338
Country:
Poland
Status:
Recruiting
Facility:
Name:
Instytut Centrum Zdrowia Matki Polki (Iczmp)
Address:
City:
Lodz
Zip:
93-338
Country:
Poland
Status:
Recruiting
Facility:
Name:
SPSK4, Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Address:
City:
Lublin
Zip:
20-954
Country:
Poland
Status:
Recruiting
Facility:
Name:
Med Polonia Sp. Z O.O.
Address:
City:
Poznan
Zip:
60-693
Country:
Poland
Status:
Recruiting
Facility:
Name:
Institute of Oncology Prof. Dr. Ion Chiricuta
Address:
City:
Cluj- Napoca
Zip:
400015
Country:
Romania
Status:
Recruiting
Facility:
Name:
Onco Clinic Consult Sa
Address:
City:
Craiova
Zip:
200094
Country:
Romania
Status:
Recruiting
Facility:
Name:
Centrul de Oncologie Sfantu Nectarie
Address:
City:
Craiova
Zip:
200745
Country:
Romania
Status:
Not yet recruiting
Facility:
Name:
Oncocenter Oncologie Clinica S.R.L
Address:
City:
Timisoara
Zip:
300166
Country:
Romania
Status:
Recruiting
Facility:
Name:
Vall Hebron University Hospital
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinic I Provincial de Barcelona
Address:
City:
Barcelona
Zip:
8036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Arnau de Vilanova
Address:
City:
Lleida
Zip:
25198
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Regional Universitario Malaga
Address:
City:
Malaga
Zip:
29011
Country:
Spain
Status:
Recruiting
Facility:
Name:
CHUO
Address:
City:
Ourense
Zip:
32005
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Univ Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario y Politecnico de La Fe
Address:
City:
Valenica
Zip:
46026
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Miguel Servet
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Kantonsspital Baselland
Address:
City:
Liestal
Zip:
4410
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Kantonsspital St. Gallen
Address:
City:
St. Gallen
Zip:
9007
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Spital Sts Ag
Address:
City:
Thun
Zip:
3600
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
China Medical University Hospital
Address:
City:
Hsia
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10055
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Faculty of Medicine Chulalongkorn University
Address:
City:
Bangkok
Zip:
10330
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Ramathibodi Hospital
Address:
City:
Bangkok
Zip:
10400
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Siriraj Hospital
Address:
City:
Bangkok
Zip:
10700
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital
Address:
City:
Chiang Mai
Zip:
50200
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Prince of Songkla University PSU - Faculty of Medicine
Address:
City:
Hat Yai
Zip:
90110
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Khon Kaen University - Faculty of Medicine-Srinagarind Hospital
Address:
City:
Mueang Nonthaburi
Zip:
40002
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Principal Investigator
Facility:
Name:
Baskent University
Address:
City:
Adana
Zip:
1230
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Adana Acibadem Hospital
Address:
City:
Seyhan
Country:
Turkey
Status:
Recruiting
Start date:
January 11, 2023
Completion date:
August 1, 2027
Lead sponsor:
Agency:
Daiichi Sankyo
Agency class:
Industry
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Daiichi Sankyo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05555732
