Trial Title:
Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
NCT ID:
NCT06151574
Condition:
Lung Cancer, Non-squamous, Non-small Cell
Conditions: Official terms:
Lung Neoplasms
Carboplatin
Pembrolizumab
Pemetrexed
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:
zongertinib
Description:
zongertinib
Arm group label:
Experimental treatment arm
Other name:
BI 1810631
Intervention type:
Drug
Intervention name:
pembrolizumab
Description:
pembrolizumab
Arm group label:
Comparator arm
Other name:
Keytruda®
Intervention type:
Drug
Intervention name:
cisplatin
Description:
platinum-pemetrexed chemotherapy
Arm group label:
Comparator arm
Intervention type:
Drug
Intervention name:
carboplatin
Description:
platinum-pemetrexed chemotherapy
Arm group label:
Comparator arm
Intervention type:
Drug
Intervention name:
pemetrexed
Description:
platinum-pemetrexed chemotherapy
Arm group label:
Comparator arm
Summary:
This study is open to adults 18 years and older with advanced or metastatic non-small
cell lung cancer. People can join the study if they have tumours with HER2 mutations and
have not yet received any systemic therapy including chemotherapy for advanced or
metastatic lung cancer. The purpose of this study is to find out whether a medicine
called zongertinib (BI 1810631) can slow down the worsening of advanced non-small cell
lung cancer better than the standard treatment available. Zongertinib may slow cancer
cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase
survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed
chemotherapy.
Participants are put into 2 groups by chance. One group receives zongertinib at regular
times throughout the study and the other group receives infusions of pembrolizumab,
pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed
chemotherapy) into a vein.
Participants may be in the study up to a maximum of 70 months. During this time, they
visit the study site about every 3 weeks for study procedures. The doctors regularly
check the size of the tumour with a CT or MRI scan, at the beginning of the study and
every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors
regularly check whether the cancer has spread to other parts of the body. The doctors
also regularly check participants' health and take note of any unwanted effects. The time
it takes for the cancer to worsen is compared between the 2 groups to see whether the
treatment works. The participants also fill in questionnaires about their symptoms and
quality of life.
Criteria for eligibility:
Criteria:
Inclusion criteria:
1. Signed and dated written informed consent form (ICF) in accordance with
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local
legislation prior to admission to the trial.
2. Patients ≥18 years of age or over the legal age of consent in countries where that
is greater than 18 years at the time of signature of the ICF.
3. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic
non-squamous Non-small cell lung cancer (NSCLC).
4. Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine
kinase domain (TKD) as per local lab results.
5. An archival tumor tissue sample must be submitted to the central laboratory after
inclusion of the patient to retrospectively confirm the HER2 status. If no archival
tissue is available, this may be acceptable in exceptional cases after written
agreement with the sponsor.
6. Patients who have not received any systemic treatment for unresectable, locally
advanced or metastatic disease and are not eligible for curative therapy.
7. Presence of at least one measurable lesion according to Response evaluation criteria
in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology
assessment.
8. Eligible to receive treatment with the selected platinum-based doublet-chemotherapy
(i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in
accordance with the Summaries of Product Characteristics (SmPC)/Product Information.
Further inclusion criteria apply.
Exclusion criteria:
1. Previous or concomitant malignancies other than the one treated in this trial within
the last 5 years, except;
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ
- other effectively treated malignancy that is considered cured by local
treatment
2. Tumors with targetable alterations with approved available therapy.
3. Lung-specific intercurrent clinically significant severe illness based on
investigators assessment.
4. Patients who must or wish to continue the intake of restricted medications or any
drug considered likely to interfere with the safe conduct of the trial.
5. Major surgery (major according to the investigator's assessment) performed within 4
weeks prior to randomization or planned within 6 months after screening, e.g. hip
replacement.
6. Any history of or concomitant condition that, in the opinion of the investigator,
would compromise the patient's ability to comply with the trial or interfere with
the evaluation of the safety and efficacy of the test drug.
7. History or presence of cardiovascular abnormalities such as uncontrolled
hypertension, congestive heart failure New York Heart Association (NYHA)
classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia which
are considered as clinically relevant by the investigator. Myocardial infarction,
stroke, or pulmonary embolism within 6 months prior to randomization.
8. Any clinically important abnormalities (as assessed by the investigator) in rhythm,
conduction, or morphology of resting electrocardiograms, e.g. complete left bundle
branch block, third degree heart block.
Further exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clearview Cancer Institute
Address:
City:
Huntsville
Zip:
35805
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Mohtaseb Cancer Center and Blood Disorders, LLC
Address:
City:
Bullhead City
Zip:
86442
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Precision NextGen Oncology
Address:
City:
Beverly Hills
Zip:
90212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
OPN Healthcare, Inc.
Address:
City:
Glendale
Zip:
91203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
St. Louis Cancer Care, LLP
Address:
City:
Bridgeton
Zip:
63044
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Oncology Hematology Associates
Address:
City:
Springfield
Zip:
65807
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Northwell Health
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Regional Medical Oncology Center
Address:
City:
Wilson
Zip:
27893
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Gabrail Cancer Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Carolina Blood and Cancer Care Associates, PA
Address:
City:
Rock Hill
Zip:
29732
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Virginia Cancer Specialists, PC
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Edmonds
Zip:
98026
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Issaquah
Zip:
98029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Royal North Shore Hospital
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1800271035
Email:
australia@bitrialsupport.com
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1800271035
Email:
australia@bitrialsupport.com
Facility:
Name:
Austin Health
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1800271035
Email:
australia@bitrialsupport.com
Facility:
Name:
St John of God Subiaco Hospital
Address:
City:
Subiaco
Zip:
6008
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1800271035
Email:
australia@bitrialsupport.com
Facility:
Name:
Krems University Hospital
Address:
City:
Krems
Zip:
3500
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0800017900
Email:
oesterreich@bitrialsupport.com
Facility:
Name:
Brussels - HOSP Jules Bordet
Address:
City:
Anderlecht
Zip:
1070
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
UNIV UZ Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
080049616
Email:
belgique@bitrialsupport.com
Facility:
Name:
Associacao Dr. Bartholomeu Tacchini
Address:
City:
Bento Goncalves
Zip:
95700-084
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08008919295
Email:
brasil@bitrialsupport.com
Facility:
Name:
Hospital do Cancer de Londrina
Address:
City:
Londrina
Zip:
86015-520
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08008919295
Email:
brasil@bitrialsupport.com
Facility:
Name:
Hospital Sao Lucas da PUCRS
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08008919295
Email:
brasil@bitrialsupport.com
Facility:
Name:
OncoClinicas Rio de Janeiro
Address:
City:
Rio de Janeiro
Zip:
22250-040
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08008919295
Email:
brasil@bitrialsupport.com
Facility:
Name:
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Address:
City:
Santo André
Zip:
09060-650
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08008919295
Email:
brasil@bitrialsupport.com
Facility:
Name:
ICESP - Instituto do Cancer do Estado de Sao Paulo
Address:
City:
Sao Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08008919295
Email:
brasil@bitrialsupport.com
Facility:
Name:
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Address:
City:
São José do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08008919295
Email:
brasil@bitrialsupport.com
Facility:
Name:
Bradford Hill- Centro de Investigación Clínica
Address:
City:
Recoleta
Zip:
8420383
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
800392345
Email:
chile@bitrialsupport.com
Facility:
Name:
Cancer Hospital of Chinese Academy of Medical Science
Address:
City:
Beijing
Zip:
1000021
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Zip:
610042
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
The First Affiliated Hospital, Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Zhongshan Hospital Affiliated to Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Taizhou Hospital of Zhejiang Province
Address:
City:
Taizhou
Zip:
317099
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
The First Affiliated Hospital of Wenzhou Med College
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Wuhan Union Hospital
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
CTR Leon Berard
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
HOP Nord
Address:
City:
Marseille
Zip:
13015
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
HOP Tenon
Address:
City:
Paris
Zip:
75020
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
INS Curie
Address:
City:
Paris
Zip:
75248
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
HOP Pontchaillou
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
HOP Civil
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
INS Claudius Regaud IUCT-Oncopole
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
INS Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0805102354
Email:
france@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Augsburg
Address:
City:
Augsburg
Zip:
86156
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Gemeinschaftskrankenhaus Havelhöhe gGmbH
Address:
City:
Berlin
Zip:
14089
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Carl Gustav Carus Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Justus-Liebig Universität Gießen
Address:
City:
Gießen
Zip:
35392
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69126
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Köln (AöR)
Address:
City:
Köln
Zip:
50937
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Pius-Hospital, Oldenburg
Address:
City:
Oldenburg
Zip:
26121
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Tübingen
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Queen Elizabeth Hospital
Address:
City:
Hong Kong
Zip:
51727
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
800965365
Email:
hongkong@bitrialsupport.com
Facility:
Name:
Princess Margaret Hospital
Address:
City:
Hong Kong
Zip:
999077
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
800965365
Email:
hongkong@bitrialsupport.com
Facility:
Name:
Queen Mary Hospital
Address:
City:
Hong Kong
Zip:
999077
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
800965365
Email:
hongkong@bitrialsupport.com
Facility:
Name:
Rambam Medical Center
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1809388162
Email:
israel@bitrialsupport.com
Facility:
Name:
Meir Medical Center
Address:
City:
Kfar-Saba
Zip:
4428164
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1809388162
Email:
israel@bitrialsupport.com
Facility:
Name:
Rabin Medical Center Beilinson
Address:
City:
Petach Tikva
Zip:
49100
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1809388162
Email:
israel@bitrialsupport.com
Facility:
Name:
Sourasky Medical Center
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1809388162
Email:
israel@bitrialsupport.com
Facility:
Name:
Istituto Di Candiolo
Address:
City:
Candiolo (TO)
Zip:
10060
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
800977373
Email:
italia@bitrialsupport.com
Facility:
Name:
AOU Policlinico Umberto I
Address:
City:
Roma
Zip:
00161
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
800977373
Email:
italia@bitrialsupport.com
Facility:
Name:
Aichi Cancer Center Hospital
Address:
City:
Aichi, Nagoya
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Hirosaki University Hospital
Address:
City:
Aomori, Hirosaki
Zip:
036-8563
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Chiba, Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Shikoku Cancer Center
Address:
City:
Ehime, Matsuyama
Zip:
791-0280
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Kyushu University Hospital
Address:
City:
Fukuoka, Fukuoka
Zip:
812-8582
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Hakodate Goryoukaku Hospital
Address:
City:
Hokkaido, Hakodate
Zip:
040-8611
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Hokkaido Cancer Center
Address:
City:
Hokkaido, Sapporo
Zip:
003-0804
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Kanazawa University Hospital
Address:
City:
Ishikawa, Kanazawa
Zip:
920-8641
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
St. Marianna University Hospital
Address:
City:
Kanagawa, Kawasaki
Zip:
216-8511
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Kanagawa, Yokohama
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
University Hospital Kyoto Prefectural University of Medicine
Address:
City:
Kyoto, Kyoto
Zip:
602-8566
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Tohoku University Hospital
Address:
City:
Miyagi, Sendai
Zip:
980-8574
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayama, Okayama
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka, Osaka
Zip:
541-8567
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Shizuoka, Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Juntendo University Hospital
Address:
City:
Tokyo, Bunkyo-ku
Zip:
113-8431
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Komagome Hospital
Address:
City:
Tokyo, Bunkyo-ku
Zip:
113-8677
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo, Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Japanese Foundation for Cancer Research
Address:
City:
Tokyo, Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Wakayama Medical University Hospital
Address:
City:
Wakayama, Wakayama
Zip:
641-8510
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0120201230
Email:
nippon@bitrialsupport.com
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongiu
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
National Cancer Center
Address:
City:
Goyang
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Kangbuk Samsung Hospital
Address:
City:
Seoul
Zip:
03181
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
The Catholic University of Korea, St.Vincent's Hospital
Address:
City:
Suwon
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Health Pharma Professional Research S.A. de C.V.
Address:
City:
Ciudad de Mexico
Zip:
03100
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
018000623749
Email:
mexico@bitrialsupport.com
Facility:
Name:
Centro Oncologico Personalizado
Address:
City:
Mexico
Zip:
06760
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
018000623749
Email:
mexico@bitrialsupport.com
Facility:
Name:
FAICIC S de RL de C.V.
Address:
City:
Veracruz
Zip:
91900
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
018000623749
Email:
mexico@bitrialsupport.com
Facility:
Name:
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08000204613
Email:
nederland@bitrialsupport.com
Facility:
Name:
Maastricht University
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08000204613
Email:
nederland@bitrialsupport.com
Facility:
Name:
Vestre Viken HF, Drammen Sykehus
Address:
City:
Drammen
Zip:
N-3004
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
80058261
Email:
norge@bitrialsupport.com
Facility:
Name:
Oslo Universitetssykehus HF, Radiumhospitalet
Address:
City:
Oslo
Zip:
0450
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
80058261
Email:
norge@bitrialsupport.com
Facility:
Name:
Polish Mother's Memorial Hospital - Research Institute
Address:
City:
Lodz
Zip:
93-338
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
008001218830
Email:
polska@bitrialsupport.com
Facility:
Name:
Greater Poland Center of Pulmonology and Thoracic Surgery
Address:
City:
Poznan
Zip:
60-569
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
008001218830
Email:
polska@bitrialsupport.com
Facility:
Name:
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
Address:
City:
Poznan
Zip:
60693
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
008001218830
Email:
polska@bitrialsupport.com
Facility:
Name:
Hospital CUF Descobertas
Address:
City:
Lisboa
Zip:
1350-352
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
800856070
Email:
portugal@bitrialsupport.com
Facility:
Name:
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
Address:
City:
Lisboa
Zip:
1769-001
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
800856070
Email:
portugal@bitrialsupport.com
Facility:
Name:
Hospital CUF Porto
Address:
City:
Porto
Zip:
4100-180
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
800856070
Email:
portugal@bitrialsupport.com
Facility:
Name:
Pan American Center for Oncology Trials, LLC
Address:
City:
Rio Piedras
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
18336022368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119228
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
8001207344
Email:
singapore@bitrialsupport.com
Facility:
Name:
National Cancer Centre Singapore
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
8001207344
Email:
singapore@bitrialsupport.com
Facility:
Name:
Hospital A Coruña
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital General Universitario de Alicante
Address:
City:
Alicante
Zip:
03010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08026
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital de Basurto
Address:
City:
Bilbao
Zip:
48013
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Duran i Reynals
Address:
City:
L'Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Ramón y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Regional Universitario de Málaga
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Virgen del Rocío
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Clínico de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Sahlgrenska Universitetsjukhuset
Address:
City:
Göteborg
Zip:
413 45
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0200880001
Email:
sverige@bitrialsupport.com
Facility:
Name:
Karolinska Universitetssjukhuset Solna
Address:
City:
Stockholm
Zip:
171 76
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0200880001
Email:
sverige@bitrialsupport.com
Facility:
Name:
Kaohsiung Chang Gung Memorial Hospital
Address:
City:
Kaohsiung
Zip:
83301
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0809092098
Email:
taiwan@bitrialsupport.com
Facility:
Name:
Chung Shan Medical University Hospital
Address:
City:
Taichung
Zip:
404
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0809092098
Email:
taiwan@bitrialsupport.com
Facility:
Name:
Chang Gung Memorial Hospital(Linkou)
Address:
City:
Taoyuan
Zip:
330
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0809092098
Email:
taiwan@bitrialsupport.com
Facility:
Name:
Leicester Royal Infirmary
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08000514022
Email:
unitedkingdom@bitrialsupport.com
Facility:
Name:
Guy's Hospital
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08000514022
Email:
unitedkingdom@bitrialsupport.com
Facility:
Name:
The Royal Marsden Hospital, Chelsea
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08000514022
Email:
unitedkingdom@bitrialsupport.com
Facility:
Name:
The Royal Marsden Hospital, Sutton
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08000514022
Email:
unitedkingdom@bitrialsupport.com
Start date:
January 15, 2024
Completion date:
May 25, 2028
Lead sponsor:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Source:
Boehringer Ingelheim
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06151574
https://www.mystudywindow.com