Trial Title:
HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
NCT ID:
NCT04619004
Condition:
Non-Small Cell Lung Cancer Metastatic
Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Patritumab deruxtecan
Antibodies, Monoclonal
Conditions: Keywords:
Non-Small Cell Lung Cancer Metastatic
Non-Small Cell Lung Cancer with Mutation in Epidermal Growth Factor Receptor
Epidermal growth factor receptor
HER3-DXd
Patritumab Deruxtecan
U3-1402
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Patritumab Deruxtecan (Fixed dose)
Description:
Patritumab deruxtecan will be dosed at 5.6 mg/kg as an intravenous (IV) infusion
administered on Day 1 of each 21-day cycle.
Arm group label:
Study Group 1: Patritumab deruxtecan 5.6 mg/kg
Other name:
U3-1402
Other name:
HER3-DXd
Intervention type:
Drug
Intervention name:
Patritumab Deruxtecan (Up-Titration)
Description:
Patritumab deruxtecan will be dosed as an intravenous (IV) infusion administered at Cycle
1, 3.2 mg/kg; Cycle 2, 4.8 mg/kg; Cycle 3 and subsequent cycles, 6.4 mg/kg administered
on Day 1 of each 21-day cycle.
Arm group label:
Study Group 2: Patritumab deruxtecan Up-Titration
Other name:
U3-1402
Other name:
HER3-DXd
Summary:
This study is designed to evaluate the antitumor activity of patritumab deruxtecan in
participants with metastatic or locally advanced NSCLC with an activating EGFR mutation
(exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR
TKI and 1 platinum-based chemotherapy-containing regimen.
Detailed description:
This study will initially randomize participants to one of 2 arms in a 1:1 ratio to
receive either a 5.6 mg/kg fixed dose regimen or an up-titration dose regimen of
patritumab deruxtecan (HER3-DXd, U3-1402).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for inclusion in this
study.
- Sign and date the tissue informed consent form (ICF) and the main ICF, prior to the
start of any study-specific qualification procedures.
- Male or female participants aged ≥18 years (follow local regulatory requirements if
the legal age of consent for study participation is >18 years old).
- Histologically or cytologically documented locally advanced or metastatic NSCLC not
amenable to curative surgery or radiation.
- Documentation of radiological disease progression while on/after receiving most
recent treatment regimen for locally advanced or metastatic disease. Participants
must have received both of the following:
- Prior treatment with osimertinib. Participants receiving an EGFR TKI at the
time of signing informed consent should continue to take the EGFR TKI until 5
days prior to Cycle 1 Day 1. Participants in South Korea known to harbor a
clinically actionable genomic alteration in addition to EGFR mutation (e.g.,
anaplastic lymphoma kinase [ALK] or ROS1 protocol oncogene 1 [ROS1] fusion) for
which treatment is available must have also received prior treatment with at
least 1 approved genotype-directed therapy, unless unable (i.e., if
contraindicated). No new testing for these genomic alterations (e.g., ALK or
ROS1 fusion) is required for Screening.
- Systemic therapy with at least 1 platinum-based chemotherapy regimen.
- Documentation of an EGFR-activating mutation detected from tumor tissue or blood
sample: exon 19 deletion or L858R.
- At least 1 measurable lesion confirmed by BICR as per RECIST v1.1
- Consented and willing to provide required tumor tissue of sufficient quantity and of
adequate tumor tissue content. Required tumor tissue can be provided as either:
- Pretreatment tumor biopsy from at least 1 lesion not previously irradiated and
amenable to core biopsy OR
- Archival tumor tissue collected from a biopsy performed within 3 months prior
to signing of the tissue consent and since progression while on or after
treatment with the most recent cancer therapy regimen.
- Eastern Cooperative Oncology Group Performance Standard of 0 or 1 at Screening.
- Has adequate bone marrow reserve and organ function based on local laboratory data
within 14 days prior to Cycle 1 Day 1:
- Platelet count : ≥100,000/mm^3 or ≥100 × 10^9/L (platelet transfusions are not
allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility)
- Hemoglobin: ≥9.0 g/dL (transfusion and/or growth factor support is allowed)
- Absolute neutrophil count: ≥1500/mm^3 or ≥1.5 × 10^9/L
- Serum creatinine (SCr) or creatinine clearance (CrCl): SCr ≤1.5 × upper limit
of normal (ULN), OR CrCl ≥30 mL/min as calculated using the Cockcroft-Gault
equation or measured CrCl
- Aspartate aminotransferase/alanine aminotransferase: ≤3 × ULN (if liver
metastases are present, ≤5 × ULN)
- Total bilirubin: ≤1.5 × ULN if no liver metastases (<3 × ULN in the presence of
documented Gilbert's syndrome [unconjugated hyperbilirubinemia] or liver
metastases)
- Serum albumin: ≥2.5 g/dL
- Prothrombin time (PT) or PT-International normalized ratio (INR) and activated
partial thromboplastin time (aPTT)/PTT: ≤1.5 × ULN, except for subjects on
coumarin-derivative anticoagulants or other similar anticoagulant therapy, who
must have PT-INR within therapeutic range as deemed appropriate by the
Investigator
Exclusion Criteria:
Participants meeting any exclusion criteria for this study will be excluded from this
study.
- Any previous histologic or cytologic evidence of small cell OR combined small
cell/non-small cell disease in the archival tumor tissue or pretreatment tumor
biopsy.
- Any history of interstitial lung disease (including pulmonary fibrosis or radiation
pneumonitis), has current interstitial lung disease (ILD), or is suspected to have
such disease by imaging during screening.
- Clinically severe respiratory compromise (based on Investigator's assessment)
resulting from intercurrent pulmonary illnesses including, but not limited to:
- Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months prior
to the study enrollment, severe asthma, severe chronic obstructive pulmonary
disease [COPD]), restrictive lung disease, pleural effusion);
- Any autoimmune, connective tissue or inflammatory disorders with pulmonary
involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis); OR
prior complete pneumonectomy.
- Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or
equivalent anti-inflammatory or any form of immunosuppressive therapy prior to
enrollment. Participants who require use of bronchodilators, inhaled or topical
steroids, or local steroid injections may be included in the study.
- Evidence of any leptomeningeal disease.
- Evidence of clinically active spinal cord compression or brain metastases.
- Inadequate washout period prior to Cycle 1 Day 1, defined as:
- Whole brain radiation therapy <14 days or stereotactic brain radiation therapy
<7 days;
- Any cytotoxic chemotherapy, investigational agent or other anticancer drug(s)
from a previous cancer treatment regimen or clinical study (other than EGFR
TKI), <14 days or 5 half-lives, whichever is longer;
- Monoclonal antibodies, other than immune checkpoint inhibitors, such as
bevacizumab (anti-VEGF) and cetuximab (anti-EGFR) <28 days;
- Immune checkpoint inhibitor therapy <21 days;
- Major surgery (excluding placement of vascular access) <28 days;
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field
of radiation <28 days or palliative radiation therapy <14 days; or
- Chloroquine or hydroxychloroquine <14 days.
- Prior treatment with an anti-human epidermal growth factor receptor 3 (HER3)
antibody or single-agent topoisomerase I inhibitor.
- Prior treatment with an antibody drug conjugate (ADC) that consists of any
topoisomerase I inhibitor
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities
(other than alopecia) not yet resolved to National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, Grade ≤1 or baseline.
Participants with chronic Grade 2 toxicities may be eligible at the discretion of
the Investigator after consultation with the Sponsor Medical Monitor or designee.
- Has history of other active malignancy within 3 years prior to enrollment, except:
- Adequately treated non-melanoma skin cancer;
- Superficial bladder tumors (Ta, Tis, T1);
- Adequately treated intraepithelial carcinoma of the cervix uteri;
- Low risk non-metastatic prostate cancer (with Gleason score <7, and following
local treatment or ongoing active surveillance);
- Any other curatively treated in situ disease.
- Uncontrolled or significant cardiovascular disease prior to Cycle 1 Day 1
- Active hepatitis B and/or hepatitis C infection, such as those with serologic
evidence of viral infection within 28 days of Cycle 1 Day 1.
- Participant with any human immunodeficiency virus (HIV) infection.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
Moores Cancer Center at the UC San Diego Health
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Facility:
Name:
Pacific Shores Medical Group
Address:
City:
Long Beach
Zip:
90813
Country:
United States
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Facility:
Name:
University of California at Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Facility:
Name:
Cedars Sinai
Address:
City:
West Hollywood
Zip:
90048
Country:
United States
Facility:
Name:
University of Colorado Denver - Anschutz Medical Campus
Address:
City:
Aurora
Zip:
80045
Country:
United States
Facility:
Name:
Florida Cancer Specialists - South
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Facility:
Name:
AdventHealth Orlando
Address:
City:
Orlando
Zip:
32804
Country:
United States
Facility:
Name:
Memorial Healthcare System
Address:
City:
Pembroke Pines
Zip:
33021
Country:
United States
Facility:
Name:
Florida Cancer Specialist-North
Address:
City:
Saint Petersburg
Zip:
33770
Country:
United States
Facility:
Name:
Florida Cancer Specialists-Panhandle
Address:
City:
Tallahassee
Zip:
32308
Country:
United States
Facility:
Name:
H. Lee Moffitt Cancer Center & Research Institute
Address:
City:
Tampa
Zip:
33612
Country:
United States
Facility:
Name:
Florida Cancer Specialists-East
Address:
City:
West Palm Beach
Zip:
33401
Country:
United States
Facility:
Name:
Emory University
Address:
City:
Dunwoody
Zip:
30338
Country:
United States
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Facility:
Name:
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Facility:
Name:
Massachusetts General Hospital (MGH) - Hematology/Oncology
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
Beth Israel Deaconess Medical Center, Harvard Medical School
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Henry Ford Cancer Institute/Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10461
Country:
United States
Facility:
Name:
Mount Sinai Hospital
Address:
City:
New York
Zip:
10029
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Facility:
Name:
Cleveland Clinic - Main Campus
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Facility:
Name:
Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga
Address:
City:
Chattanooga
Zip:
37404
Country:
United States
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center
Address:
City:
Charlottesville
Zip:
22903
Country:
United States
Facility:
Name:
Virginia Cancer Specialist, PC
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Facility:
Name:
University of Washington/Seattle Cancer Care Alliance
Address:
City:
Seattle
Zip:
98109
Country:
United States
Facility:
Name:
Blacktown Hospital
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Facility:
Name:
The Chris O'Brien Lifehouse
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Facility:
Name:
St George Public Hospital
Address:
City:
Kogarah
Zip:
2217
Country:
Australia
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Facility:
Name:
St John of God Subiaco Hospital
Address:
City:
Subiaco
Zip:
6008
Country:
Australia
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Facility:
Name:
Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
Address:
City:
Wien
Zip:
1030
Country:
Austria
Facility:
Name:
Universitaire Ziekenhuis Gasthuisberg
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Facility:
Name:
MHAT Uni Hospital OOD
Address:
City:
Panagyurishte
Zip:
4500
Country:
Bulgaria
Facility:
Name:
Complex Oncological Center - Russe
Address:
City:
Russe
Zip:
7002
Country:
Bulgaria
Facility:
Name:
MHAT Serdika
Address:
City:
Sofia
Zip:
1303
Country:
Bulgaria
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100036
Country:
China
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Chang chun
Zip:
130012
Country:
China
Facility:
Name:
University of Electronic Science & Technology of China (UESTC) - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Facility:
Name:
The First Affiliated Hospital of College of Medicine Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Facility:
Name:
Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital)
Address:
City:
Harbin
Zip:
150081
Country:
China
Facility:
Name:
General Hospital of Eastern Theater Command
Address:
City:
Nanjing
Zip:
210002
Country:
China
Facility:
Name:
Fudan University - Shanghai Cancer Center FUSCC
Address:
City:
Shanghai
Zip:
200032
Country:
China
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110001
Country:
China
Facility:
Name:
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Facility:
Name:
CHU Toulouse - Hopital Larrey
Address:
City:
Toulouse
Zip:
31059
Country:
France
Facility:
Name:
University Hospital of Nantes - Thoracic Oncology
Address:
City:
Nantes
Zip:
44000
Country:
France
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69008
Country:
France
Facility:
Name:
Hopital Morvan CHU de Brest
Address:
City:
Brest
Zip:
29609
Country:
France
Facility:
Name:
Centre Hospitalier Universitaire de Grenoble
Address:
City:
Grenoble
Zip:
38043
Country:
France
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75248
Country:
France
Facility:
Name:
Hopital Pontchaillou
Address:
City:
Rennes
Zip:
35000
Country:
France
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Facility:
Name:
Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim
Address:
City:
Köln
Zip:
51109
Country:
Germany
Facility:
Name:
Universitaet zu Koeln - Uniklinik Koeln
Address:
City:
Koeln
Zip:
50937
Country:
Germany
Facility:
Name:
LungenClinic Grosshansdorf
Address:
City:
Großhansdorf
Zip:
22927
Country:
Germany
Facility:
Name:
University Cancer Center
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Facility:
Name:
Universitaet zu Koeln - Uniklinik Koeln
Address:
City:
Koeln
Zip:
50931
Country:
Germany
Facility:
Name:
Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim
Address:
City:
Koeln
Zip:
51109
Country:
Germany
Facility:
Name:
Azienda Ospedaliero Universitaria di Parma
Address:
City:
Parma
Zip:
43126
Country:
Italy
Facility:
Name:
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Facility:
Name:
IRCCS - Istituto Scientifico Romagnolo per lo Studio e La Cura Dei Tumori ISRT
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Facility:
Name:
Fondazione IRCCS Istituto Nazionale Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Facility:
Name:
Humanitas Cancer Center
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-0882
Country:
Japan
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Facility:
Name:
National Hospital Organization Shikoku Cancer Center
Address:
City:
Matsuyama
Zip:
791-0280
Country:
Japan
Facility:
Name:
National Hospital Organization Hokkaido Cancer Center
Address:
City:
Sapporo
Zip:
003-0804
Country:
Japan
Facility:
Name:
Hyogo Cancer Center
Address:
City:
Akashi
Zip:
673-8558
Country:
Japan
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Chiba
Zip:
277-8577
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Ariake
Zip:
135-8550
Country:
Japan
Facility:
Name:
Sendai Kousei Hospital
Address:
City:
Sendai
Zip:
980-0873
Country:
Japan
Facility:
Name:
Kansai Medical University Hospital
Address:
City:
Hirakata
Zip:
573-1191
Country:
Japan
Facility:
Name:
Kindai University Hospital
Address:
City:
Ōsaka-sayama
Zip:
589-8511
Country:
Japan
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo Ku
Zip:
104-0045
Country:
Japan
Facility:
Name:
Niigata Cancer Center Hospital
Address:
City:
Chuo Ku Niigata-shi
Zip:
961-8566
Country:
Japan
Facility:
Name:
National Hospital Organization Kyushu Cancer Center
Address:
City:
Fukuoka
Zip:
811-1347
Country:
Japan
Facility:
Name:
National Hospital Organization Hokkaido Cancer Center
Address:
City:
Sapporo
Zip:
003-0804
Country:
Japan
Facility:
Name:
Asan Medical Center
Address:
City:
Songpa-gu
Zip:
05505
Country:
Korea, Republic of
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Facility:
Name:
Kyungpook National University Chilgok Hospital
Address:
City:
Daegu
Zip:
41404
Country:
Korea, Republic of
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam
Zip:
13620
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Facility:
Name:
The Catholic University of Korea, Seoul St. Marys Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Facility:
Name:
Netherlands Cancer Institute
Address:
City:
Amsterdam
Zip:
1066CX
Country:
Netherlands
Facility:
Name:
National University Cancer Institute National University Hospital
Address:
City:
Singapore
Zip:
119074
Country:
Singapore
Facility:
Name:
National Cancer Centre Singapore NCCS
Address:
City:
Singapore
Zip:
169610
Country:
Singapore
Facility:
Name:
OncoCare Cancer Centre- Gleneagles Medical Centre
Address:
City:
Singapore
Zip:
258499
Country:
Singapore
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Facility:
Name:
Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Facility:
Name:
Hospital Universitario Puerta de Hierro de Majadahonda
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Facility:
Name:
Hospital Universitario Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
START Madrid - Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Facility:
Name:
Hospital Regional Universitario Carlos Haya
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Facility:
Name:
Hospital Clinico Universitario Lozano Bleza
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Facility:
Name:
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
Address:
City:
Niaosong
Zip:
833
Country:
Taiwan
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan City
Zip:
704
Country:
Taiwan
Facility:
Name:
E-Da Hospital
Address:
City:
Kaohsiung City
Zip:
824
Country:
Taiwan
Facility:
Name:
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
Address:
City:
Niaosong
Zip:
83301
Country:
Taiwan
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Facility:
Name:
Chung Shan Medical University Hospital
Address:
City:
Taichung
Zip:
420
Country:
Taiwan
Facility:
Name:
National Taiwan University Hospital NTUH
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Facility:
Name:
MacKay Memorial Hospital
Address:
City:
Taipei
Zip:
10449
Country:
Taiwan
Facility:
Name:
Chang Gung Memorial Hospital - Linkou Branch
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Facility:
Name:
University Hospital Birmingham NHS Trust
Address:
City:
Birmingham
Zip:
B9 5SS
Country:
United Kingdom
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
London
Zip:
E20 1JQ
Country:
United Kingdom
Facility:
Name:
University College London Hospitals
Address:
City:
London
Zip:
NW12PG
Country:
United Kingdom
Facility:
Name:
The Christie Hospital
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Start date:
February 2, 2021
Completion date:
January 30, 2026
Lead sponsor:
Agency:
Daiichi Sankyo
Agency class:
Industry
Collaborator:
Agency:
Daiichi Sankyo Co., Ltd.
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/NCT04619004
