Trial Title:
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
NCT ID:
NCT05740566
Condition:
Small Cell Lung Cancer (SCLC)
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Topotecan
Amrubicin
AMG 757
Conditions: Keywords:
Small Cell Lung Cancer
SCLC
AMG 757
Tarlatamab
Study type:
Interventional
Study phase:
Phase 3
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:
Tarlatamab
Description:
Tarlatamab will be administered as an IV infusion.
Arm group label:
Tarlatamab
Other name:
AMG 757
Intervention type:
Drug
Intervention name:
Lurbinectedin
Description:
Lurbinectedin will be administered per local SOC.
Arm group label:
Standard of Care
Intervention type:
Drug
Intervention name:
Topotecan
Description:
Topotecan will be administered per local SOC.
Arm group label:
Standard of Care
Intervention type:
Drug
Intervention name:
Amrubicin
Description:
Amrubicin will be administered per local SOC.
Arm group label:
Standard of Care
Summary:
The main objective is to compare the efficacy of tarlatamab with standard of care (SOC)
on prolonging overall survival (OS).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participant has provided informed consent prior to initiation of any study specific
activities/procedures.
- Age ≥ 18 years (or legal adult age within country, whichever is older) at the time
of signing the informed consent.
- Histologically or cytologically confirmed SCLC with demonstrated progression or
relapse.
- Participants who progressed or recurred following 1 platinum-based regimen.
- Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
- Minimum life expectancy of 12 weeks.
- Adequate organ function.
Exclusion Criteria:
- Disease Related
- Symptomatic central nervous system (CNS) metastases with exceptions defined in
the protocol.
- Diagnosis or evidence of leptomeningeal disease.
- Prior history of immune checkpoint inhibitors resulting in events defined in
the protocol.
- Other Medical Conditions
- Active autoimmune disease that has required systemic treatment (except
replacement therapy) within the past 2 years or any other diseases requiring
immunosuppressive therapy.
- History of solid organ transplantation.
- History of other malignancy within the past 2 years, with exceptions defined in
the protocol.
- Myocardial infarction and/or symptomatic congestive heart failure (New York
Heart Association > class II) within 12 months prior to first dose of study
treatment.
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within
12 months prior to first dose of study treatment.
- Presence or history of viral infection based on criteria per protocol.
- Receiving systemic corticosteroid therapy or any other form of
immunosuppressive therapy within 7 days prior to first dose of study treatment.
- Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled
active systemic infection requiring antibiotics within 7 days prior to the
first dose study treatment.
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Prior/Concomitant Therapy
- Prior therapy with tarlatamab or any of the standard of care chemotherapy
included as part of this trial or participation in any tarlatamab or any other
DLL3 targeted agent clinical trial.
- Prior therapy with any selective inhibitor of the DLL3 pathway.
- Participant received more than one prior systemic therapy regimen for SCLC.
- Prior anti-cancer therapy within 21 days prior to first dose of study treatment
with exceptions defined in protocol.
- Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted
therapy with exceptions.
- Use of herbal or prescription/non-prescription medications known to inhibit
membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance
protein (BCRP) within 7 days prior to the first dose of study treatment.
- Use of herbal or prescription/non-prescription medications known to be moderate
or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior
to the first dose of study treatment.
- Use of herbal or prescription/non-prescription medications known to be moderate
or strong inducers of CYP3A enzymes within 28 days prior to first dose of study
treatment.
- Participants who have reached the limit dose of prior treatment with
cardiotoxic drugs.
- Major surgical procedures within 28 days prior to first dose of study
treatment.
- Live and live-attenuated vaccines within 14 days prior to the start of study
treatment.
- Inactive vaccines and live viral non-replicating vaccines within 3 days prior
to the first dose of study treatment.
- Currently receiving treatment in another investigational device or drug study,
or less than 30 days since ending treatment on another investigational device
or drug study(ies). Other investigational procedures while participating in
this study are excluded.
- Diagnostic Assessments
- Any previous diagnosis of transformed non-small cell lung cancer (NSCLC),
epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that
has transformed to SCLC, with exceptions defined in the protocol.
- Other Exclusions
- Female participants of childbearing potential unwilling to use protocol
specified method of contraception during treatment and for an additional 60
days after the last dose of tarlatamab.
- Female participants who are breastfeeding or who plan to breastfeed while on
study through 60 days after the last dose of tarlatamab.
- Female participants planning to become pregnant or donate eggs while on study
through 60 days after the last dose of tarlatamab.
- Female participants of childbearing potential with a positive pregnancy test
assessed at screening by a serum pregnancy test.
- Male participants with a female partner of childbearing potential who are
unwilling to practice sexual abstinence (refrain from heterosexual intercourse)
or use contraception during treatment and for an additional 60 days after the
last dose of tarlatamab.
- Male participants with a pregnant partner who are unwilling to practice
abstinence or use a condom during treatment and for an additional 60 days after
the last dose of tarlatamab.
- Male participants unwilling to abstain from donating sperm during treatment and
for an additional 60 days after the last dose of tarlatamab.
- Contraception requirements for male and female participants receiving SOC
therapies are based on regional prescribing information.
- Breastfeeding restrictions for female participants receiving SOC therapies are
based on regional prescribing information.
- Participant has known sensitivity or is contraindicated to any of the products
or components to be administered during dosing.
- Participant likely to not be available to complete all protocol-required study
visits or procedures, and/or to comply with all required study procedures.
- History or evidence of any other clinically significant disorder, condition or
disease determined by the investigator or Amgen physician that would pose a
risk to the subject safety or interfere with the study evaluation..
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of South Alabama Mitchell Cancer Institute
Address:
City:
Mobile
Zip:
36604
Country:
United States
Facility:
Name:
Alaska Oncology and Hematology
Address:
City:
Anchorage
Zip:
99508
Country:
United States
Facility:
Name:
University of Arkansas for Medical Sciences
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Facility:
Name:
University of California Los Angeles
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Facility:
Name:
University of Illinois Chicago
Address:
City:
Chicago
Zip:
60612
Country:
United States
Facility:
Name:
Indiana University
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Facility:
Name:
University of Iowa
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Facility:
Name:
Pikeville Medical Center
Address:
City:
Pikeville
Zip:
41501
Country:
United States
Facility:
Name:
Our Lady of the Lake Cancer Institute
Address:
City:
Baton Rouge
Zip:
70808
Country:
United States
Facility:
Name:
Trinity Health Saint Joseph Mercy Ann Arbor
Address:
City:
Ann Arbor
Zip:
48106
Country:
United States
Facility:
Name:
University of Minnesota Cancer Center
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Facility:
Name:
University of Missouri Health Care
Address:
City:
Columbia
Zip:
65212
Country:
United States
Facility:
Name:
Summit Medical Group, Overlook Oncology Center
Address:
City:
Summit
Zip:
91010
Country:
United States
Facility:
Name:
New York University Grossman School of Medicine and New York University Langone Hospitals
Address:
City:
New York
Zip:
10016
Country:
United States
Facility:
Name:
Perlmutter Cancer Center at New York University Langone Hospital----Long Island
Address:
City:
New York
Zip:
10016
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10021
Country:
United States
Facility:
Name:
Northport Veterans Affairs Medical Center
Address:
City:
Northport
Zip:
11768
Country:
United States
Facility:
Name:
Sanford Roger Maris Cancer Center
Address:
City:
Fargo
Zip:
58102
Country:
United States
Facility:
Name:
Sanford Oncology Clinic and Pharmacy
Address:
City:
Sioux Falls
Zip:
57104
Country:
United States
Facility:
Name:
University of Tennessee Medical Center Knoxville
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Facility:
Name:
Baptist Cancer Center
Address:
City:
Memphis
Zip:
38120
Country:
United States
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Facility:
Name:
Swedish Cancer Institute Medical Oncology
Address:
City:
Edmonds
Zip:
98026
Country:
United States
Facility:
Name:
The Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Facility:
Name:
Cemic
Address:
City:
Ciudad Autonoma de Buenos Aires
Zip:
C1431FWO
Country:
Argentina
Facility:
Name:
Hospital Universitario Austral
Address:
City:
Pilar
Zip:
B1629ODT
Country:
Argentina
Facility:
Name:
Sociedad de Beneficencia Hospital Italiano
Address:
City:
Cordoba
Zip:
X5004BAL
Country:
Argentina
Facility:
Name:
Clinica Viedma
Address:
City:
Viedma
Zip:
R8500ACE
Country:
Argentina
Facility:
Name:
Sanatorio Parque SA
Address:
City:
Rosario
Zip:
2000
Country:
Argentina
Facility:
Name:
Instituto Argentino de Diagnostico y Tratamiento IADT
Address:
City:
Buenos Aires
Zip:
C1122AAL
Country:
Argentina
Facility:
Name:
Sanatorio Allende
Address:
City:
Córdoba
Zip:
X5000JHQ
Country:
Argentina
Facility:
Name:
Liverpool Hospital
Address:
City:
Liverpool
Zip:
2170
Country:
Australia
Facility:
Name:
Calvary Mater Newcastle Hospital
Address:
City:
Waratah
Zip:
2298
Country:
Australia
Facility:
Name:
Monash Medical Centre
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Facility:
Name:
Medizinische Universitaet Graz
Address:
City:
Graz
Zip:
8036
Country:
Austria
Facility:
Name:
Universitaetsklinikum Krems
Address:
City:
Krems
Zip:
3500
Country:
Austria
Facility:
Name:
Universitair Ziekenhuis Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Facility:
Name:
Jessa Ziekenhuis - Campus Virga Jesse
Address:
City:
Hasselt
Zip:
3500
Country:
Belgium
Facility:
Name:
AZ Delta Campus Rumbeke
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Facility:
Name:
Vitaz campus Sint-Niklaas Moerland
Address:
City:
Sint-Niklaas
Zip:
9100
Country:
Belgium
Facility:
Name:
Hospital Santa Izabel
Address:
City:
Salvador
Zip:
40050-410
Country:
Brazil
Facility:
Name:
Instituto de Ensino e Pesquisa do Hospital da Bahia
Address:
City:
Salvador
Country:
Brazil
Facility:
Name:
Liga Norte-Riograndense Contra O Cancer
Address:
City:
Natal
Zip:
59075-740
Country:
Brazil
Facility:
Name:
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
Address:
City:
Ijui
Zip:
98700-000
Country:
Brazil
Facility:
Name:
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Facility:
Name:
Hospital de Amor da Amazonia
Address:
City:
Porto Velho
Zip:
76834-899
Country:
Brazil
Facility:
Name:
Beneficencia Portuguesa de Sao Paulo - Bp
Address:
City:
Sao Paulo
Zip:
01323-900
Country:
Brazil
Facility:
Name:
Oncologia Rede D Or
Address:
City:
Sao Paulo
Zip:
04502-001
Country:
Brazil
Facility:
Name:
Hospital de Base de Sao Jose do Rio Preto
Address:
City:
São José do Rio Preto
Zip:
15090-000
Country:
Brazil
Facility:
Name:
Instituto Coi
Address:
City:
Rio de Janeiro
Zip:
22793-080
Country:
Brazil
Facility:
Name:
Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
Address:
City:
São Paulo
Zip:
01246-000
Country:
Brazil
Facility:
Name:
London Health Sciences Centre
Address:
City:
London
Zip:
N6A 5W9
Country:
Canada
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Facility:
Name:
Anhui Chest Hospital
Address:
City:
Hefei
Zip:
230022
Country:
China
Facility:
Name:
Beijing Tongren Hospital affiliated to Capital Medical University
Address:
City:
Beijing
Zip:
100010
Country:
China
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Facility:
Name:
The Second Affiliated Hospital of Army Medical University, PLA
Address:
City:
Chongqing
Zip:
400037
Country:
China
Facility:
Name:
Army Special Medical Center of Peoples Liberation Army
Address:
City:
Chongqing
Zip:
400042
Country:
China
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Facility:
Name:
Mengchao Hepatobiliary Hospital of Fujian Medical University
Address:
City:
Fuzhou
Zip:
350025
Country:
China
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Facility:
Name:
Jiangmen Central Hospital
Address:
City:
Jiangmen
Zip:
529030
Country:
China
Facility:
Name:
The 4th Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050000
Country:
China
Facility:
Name:
Affiliated Cancer Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150000
Country:
China
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Facility:
Name:
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Facility:
Name:
Subei Peoples Hospital
Address:
City:
Yangzhou
Zip:
225009
Country:
China
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130012
Country:
China
Facility:
Name:
Jinan Central Hospital
Address:
City:
Jinan
Zip:
250013
Country:
China
Facility:
Name:
Shandong Tumor Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Zip:
276034
Country:
China
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Facility:
Name:
Shanxi Province Cancer Hospital
Address:
City:
Taiyuan
Zip:
30009
Country:
China
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
The First Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Facility:
Name:
The Second Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Facility:
Name:
Taizhou Hospital of Zhejiang Province
Address:
City:
Taizhou
Zip:
317099
Country:
China
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325015
Country:
China
Facility:
Name:
Beijing Chest Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
101149
Country:
China
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350011
Country:
China
Facility:
Name:
Tianjin Peoples Hospital
Address:
City:
Tianjin
Zip:
300131
Country:
China
Facility:
Name:
Weihai Municipal Hospital
Address:
City:
Weihai
Zip:
264200
Country:
China
Facility:
Name:
Fakultni nemocnice Brno
Address:
City:
Brno
Zip:
625 00
Country:
Czechia
Facility:
Name:
Masarykuv onkologicky ustav
Address:
City:
Brno
Zip:
656 53
Country:
Czechia
Facility:
Name:
Fakultni nemocnice Olomouc
Address:
City:
Olomouc
Zip:
779 00
Country:
Czechia
Facility:
Name:
Nemocnice Agel Ostrava-Vitkovice as
Address:
City:
Ostrava-Vitkovice
Zip:
703 00
Country:
Czechia
Facility:
Name:
Vseobecna fakultni nemocnice v Praze
Address:
City:
Praha 2
Zip:
128 08
Country:
Czechia
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Facility:
Name:
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
Address:
City:
Grenoble
Zip:
38700
Country:
France
Facility:
Name:
Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon
Address:
City:
Lille Cedex
Zip:
59037
Country:
France
Facility:
Name:
Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren
Address:
City:
Limoges Cedex
Zip:
87042
Country:
France
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69008
Country:
France
Facility:
Name:
Centre Hospitalier Universitaire Nord
Address:
City:
Marseille Cedex 20
Zip:
13915
Country:
France
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Facility:
Name:
Centre Hospitalier Lyon Sud
Address:
City:
Pierre-Benite cedex
Zip:
69495
Country:
France
Facility:
Name:
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Address:
City:
Rennes Cedex 9
Zip:
35033
Country:
France
Facility:
Name:
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Address:
City:
Strasbourg Cedex
Zip:
67091
Country:
France
Facility:
Name:
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Address:
City:
Toulouse Cedex 9
Zip:
31059
Country:
France
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Facility:
Name:
Charite Universitaetsmedizin Berlin, Campus Virchow
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Facility:
Name:
Universitaetsklinikum Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Facility:
Name:
Universitaetsklinikum Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Facility:
Name:
Asklepios Fachkliniken Muenchen Gauting
Address:
City:
Gauting
Zip:
82130
Country:
Germany
Facility:
Name:
LungenClinic Grosshansdorf GmbH
Address:
City:
Grosshansdorf
Zip:
22927
Country:
Germany
Facility:
Name:
Universitaetsklinikum Koeln
Address:
City:
Koeln
Zip:
50937
Country:
Germany
Facility:
Name:
Robert-Bosch-Krankenhaus
Address:
City:
Stuttgart
Zip:
70376
Country:
Germany
Facility:
Name:
Universitaetsklinikum Wuerzburg
Address:
City:
Wuerzburg
Zip:
97078
Country:
Germany
Facility:
Name:
Saint Savas Hospital
Address:
City:
Athens
Zip:
11522
Country:
Greece
Facility:
Name:
Henry Dunant Hospital Center
Address:
City:
Athens
Zip:
11526
Country:
Greece
Facility:
Name:
Thoracic General Hospital Of Athens Sotiria
Address:
City:
Athens
Zip:
11527
Country:
Greece
Facility:
Name:
Alexandra Hospital
Address:
City:
Athens
Zip:
11528
Country:
Greece
Facility:
Name:
University Hospital of Heraklion
Address:
City:
Heraklion - Crete
Zip:
71500
Country:
Greece
Facility:
Name:
Olympion Therapeftirio General Clinic Of Patras
Address:
City:
Patra
Zip:
26443
Country:
Greece
Facility:
Name:
Saint Luke Hospital
Address:
City:
Thessaloniki
Zip:
55236
Country:
Greece
Facility:
Name:
European Interbalkan Medical Center
Address:
City:
Thessaloniki
Zip:
57001
Country:
Greece
Facility:
Name:
Semmelweis Egyetem
Address:
City:
Budapest
Zip:
1083
Country:
Hungary
Facility:
Name:
Orszagos Koranyi Pulmonologiai Intezet
Address:
City:
Budapest
Zip:
1121
Country:
Hungary
Facility:
Name:
Matrai Gyogyintezet
Address:
City:
Gyongyos
Zip:
3200
Country:
Hungary
Facility:
Name:
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
Address:
City:
Szekesfehervar
Zip:
8000
Country:
Hungary
Facility:
Name:
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Address:
City:
Tatabanya
Zip:
2800
Country:
Hungary
Facility:
Name:
Reformatus Pulmonologiai Centrum
Address:
City:
Torokbalint
Zip:
2045
Country:
Hungary
Facility:
Name:
Beaumont Hospital
Address:
City:
Dublin
Zip:
9
Country:
Ireland
Facility:
Name:
Rambam Medical Center
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Facility:
Name:
Hadassah Ein-Kerem Medical Center
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Facility:
Name:
Meir Medical Center
Address:
City:
Kfar Saba
Zip:
4428164
Country:
Israel
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Facility:
Name:
Humanitas Gavazzeni
Address:
City:
Bergamo
Zip:
24125
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Universitaria Renato Dulbecco
Address:
City:
Catanzaro
Zip:
88100
Country:
Italy
Facility:
Name:
Ospedale Policlinico San Martino IRCCS
Address:
City:
Genova
Zip:
16132
Country:
Italy
Facility:
Name:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Address:
City:
Meldola (FC)
Zip:
47014
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Facility:
Name:
Azienda Ospedaliera San Giovanni Addolorata
Address:
City:
Roma
Zip:
00144
Country:
Italy
Facility:
Name:
National Hospital Organization Nagoya Medical Center
Address:
City:
Nagoya-shi
Zip:
460-0001
Country:
Japan
Facility:
Name:
Aichi Cancer Center
Address:
City:
Nagoya-shi
Zip:
464-8681
Country:
Japan
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Facility:
Name:
National Hospital Organization Shikoku Cancer Center
Address:
City:
Matsuyama-shi
Zip:
791-0280
Country:
Japan
Facility:
Name:
Kurume University Hospital
Address:
City:
Kurume-shi
Zip:
830-0011
Country:
Japan
Facility:
Name:
National Hospital Organization Hokkaido Cancer Center
Address:
City:
Sapporo-shi
Zip:
003-0804
Country:
Japan
Facility:
Name:
Hyogo Cancer Center
Address:
City:
Akashi-shi
Zip:
673-8558
Country:
Japan
Facility:
Name:
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Address:
City:
Yokohama-shi
Zip:
241-8515
Country:
Japan
Facility:
Name:
Sendai Kousei Hospital
Address:
City:
Sendai-shi
Zip:
981-0914
Country:
Japan
Facility:
Name:
Niigata Cancer Center Hospital
Address:
City:
Niigata-shi
Zip:
951-8566
Country:
Japan
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayama-shi
Zip:
700-8558
Country:
Japan
Facility:
Name:
Kansai Medical University Hospital
Address:
City:
Hirakata-shi
Zip:
573-1191
Country:
Japan
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka-shi
Zip:
541-8567
Country:
Japan
Facility:
Name:
Kindai University Hospital
Address:
City:
Osakasayama-shi
Zip:
589-8511
Country:
Japan
Facility:
Name:
Saitama Medical University International Medical Center
Address:
City:
Hidaka-Shi
Zip:
350-1298
Country:
Japan
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Facility:
Name:
Juntendo University Hospital
Address:
City:
Bunkyo-ku
Zip:
113-8431
Country:
Japan
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Facility:
Name:
Wakayama Medical University Hospital
Address:
City:
Wakayama-shi
Zip:
641-8510
Country:
Japan
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju Chungbuk
Zip:
28644
Country:
Korea, Republic of
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si Gyeonggi-do
Zip:
10408
Country:
Korea, Republic of
Facility:
Name:
Gachon University Gil Hospital
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Facility:
Name:
Gyeongsang National University Hospital
Address:
City:
Jinju-si
Zip:
52727
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si, Gyeonggi-do
Zip:
13620
Country:
Korea, Republic of
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
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:
Ulsan University Hospital
Address:
City:
Ulsan
Zip:
44033
Country:
Korea, Republic of
Facility:
Name:
Hospital Tengku Ampuan Afzan
Address:
City:
Kuantan
Zip:
25100
Country:
Malaysia
Facility:
Name:
Sarawak General Hospital
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Facility:
Name:
University Malaya Medical Centre
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Facility:
Name:
Oncare
Address:
City:
Ciudad de México
Zip:
03810
Country:
Mexico
Facility:
Name:
Health Pharma Professional Research SA de CV
Address:
City:
Mexico City
Zip:
03100
Country:
Mexico
Facility:
Name:
coi Centro Oncologico Internacional sapi de cv
Address:
City:
Tlajomulco de Zúñiga
Zip:
45640
Country:
Mexico
Facility:
Name:
Universitair Medisch Centrum Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Facility:
Name:
Leids Universitair Medisch Centrum
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Facility:
Name:
Erasmus Medisch Centrum
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Facility:
Name:
Universitair Medisch Centrum Utrecht
Address:
City:
Utrecht
Zip:
3584 CX
Country:
Netherlands
Facility:
Name:
Centrum Pulmonologii i Torakochirurgii w Bystrej
Address:
City:
Bystra
Zip:
43-360
Country:
Poland
Facility:
Name:
Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo
Address:
City:
Krakow
Zip:
31-826
Country:
Poland
Facility:
Name:
Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow
Address:
City:
Poznan
Zip:
60-569
Country:
Poland
Facility:
Name:
Hospital da Luz, SA
Address:
City:
Lisboa
Zip:
1500-650
Country:
Portugal
Facility:
Name:
Hospital Cuf Descobertas
Address:
City:
Lisboa
Zip:
1998-018
Country:
Portugal
Facility:
Name:
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Address:
City:
Matosinhos
Zip:
4464-513
Country:
Portugal
Facility:
Name:
Hospital Cuf porto
Address:
City:
Porto
Zip:
4100-180
Country:
Portugal
Facility:
Name:
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Address:
City:
Cluj Napoca
Zip:
400015
Country:
Romania
Facility:
Name:
Centrul de Oncologie Sf Nectarie SRL
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Facility:
Name:
Institutul Regional de Oncologie Iasi
Address:
City:
Iasi
Zip:
700483
Country:
Romania
Facility:
Name:
SC Oncomed SRL
Address:
City:
Timisoara
Zip:
300239
Country:
Romania
Facility:
Name:
National Cancer Centre Singapore
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Facility:
Name:
Tan Tock Seng Hospital
Address:
City:
Singapore
Zip:
308433
Country:
Singapore
Facility:
Name:
Hospital Regional Universitario de Malaga
Address:
City:
Malaga
Zip:
29011
Country:
Spain
Facility:
Name:
Hospital Clinico Universitario Lozano Blesa
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Facility:
Name:
Hospital del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Facility:
Name:
Hospital Universitari Vall d Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Facility:
Name:
Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Facility:
Name:
Hospital Universitario Puerta de Hierro Majadahonda
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Facility:
Name:
Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Hospital Clinico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Kantonsspital Graubuenden
Address:
City:
Chur
Zip:
7000
Country:
Switzerland
Facility:
Name:
Freiburg Spital
Address:
City:
Fribourg
Zip:
1708
Country:
Switzerland
Facility:
Name:
Hopitaux universitaires de Geneve
Address:
City:
Geneve 14
Zip:
1211
Country:
Switzerland
Facility:
Name:
Kantonsspital Sankt Gallen
Address:
City:
Sankt Gallen
Zip:
9007
Country:
Switzerland
Facility:
Name:
Kantonsspital Winterthur
Address:
City:
Winterthur
Zip:
8401
Country:
Switzerland
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Facility:
Name:
Veterans General Hospital - Taichung
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
70403
Country:
Taiwan
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Facility:
Name:
Memorial Ankara Hastanesi
Address:
City:
Ankara
Zip:
06520
Country:
Turkey
Facility:
Name:
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Address:
City:
Ankara
Zip:
06560
Country:
Turkey
Facility:
Name:
Ankara Bilkent Sehir Hastanesi
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Facility:
Name:
Pamukkale Universitesi Tip Fakultesi Hastanesi
Address:
City:
Denizli
Zip:
20070
Country:
Turkey
Facility:
Name:
Bagcilar Medipol Mega Universite Hastanesi
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Facility:
Name:
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Address:
City:
Istanbul
Zip:
34722
Country:
Turkey
Facility:
Name:
Ege Universitesi Tip Fakultesi Hastanesi
Address:
City:
Izmir
Zip:
35100
Country:
Turkey
Facility:
Name:
Izmir Ekonomi Universitesi Medical Point Hastanesi
Address:
City:
Izmir
Zip:
35575
Country:
Turkey
Facility:
Name:
Inonu Universitesi Turgut Ozal Tip Merkezi
Address:
City:
Malatya
Zip:
44280
Country:
Turkey
Facility:
Name:
University College London Hospital
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Facility:
Name:
Guys Hospital
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Facility:
Name:
Christie Hospital
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Start date:
May 31, 2023
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Amgen
Agency class:
Industry
Source:
Amgen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740566
http://www.amgentrials.com