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Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer (DeLLphi-304)

Primary Purpose

Small Cell Lung Cancer (SCLC)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tarlatamab
Lurbinectedin
Topotecan
Amrubicin
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer (SCLC) focused on measuring Small Cell Lung Cancer, SCLC, AMG 757, Tarlatamab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 relapsed/refractory SCLC. Participants who progressed or recurred following 1 platinum-based regimen. Provision of evaluable tumor sample for central testing. 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 Untreated or 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. Exclusion of HIV and hepatitis 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. 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, or mixed SCLC NSCLC histology. Other Exclusions Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 72 days after the last dose of tarlatamab. Female participants who are breastfeeding or who plan to breastfeed while on study through 72 days after the last dose of tarlatamab. Female participants planning to become pregnant or donate eggs while on study through 72 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 132 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 132 days after the last dose of tarlatamab. Male participants unwilling to abstain from donating sperm during treatment and for an additional 132 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.

Sites / Locations

  • Alaska Oncology and Hematology LLCRecruiting
  • Indiana U Simon Cancer CenterRecruiting
  • Pikeville Medical CenterRecruiting
  • Our Lady of the Lake Cancer InstituteRecruiting
  • Trinity Health Saint Joseph Mercy Ann ArborRecruiting
  • University of Tennessee Medical Center KnoxvilleRecruiting
  • Baptist Cancer CenterRecruiting
  • CemicRecruiting
  • Instituto Argentino de Diagnostico y Tratamiento IADTRecruiting
  • Liverpool HospitalRecruiting
  • Calvary Mater Newcastle HospitalRecruiting
  • Monash Medical CentreRecruiting
  • The Alfred HospitalRecruiting
  • Hospital de Base de Sao Jose do Rio PretoRecruiting
  • The Second Affiliated Hospital of Army Military Medical UniversityRecruiting
  • Fuzhou General HospitalRecruiting
  • Jiangmen Central HospitalRecruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • Taizhou Peoples HospitalRecruiting
  • Hadassah Ein-Kerem Medical CenterRecruiting
  • Rabin Medical CenterRecruiting
  • National Cancer Center Hospital EastRecruiting
  • National Hospital Organization Shikoku Cancer CenterRecruiting
  • Kurume University HospitalRecruiting
  • National Hospital Organization Hokkaido Cancer CenterRecruiting
  • Hyogo Cancer CenterRecruiting
  • Sendai Kousei HospitalRecruiting
  • Niigata Cancer Center HospitalRecruiting
  • Okayama University HospitalRecruiting
  • Kansai Medical University HospitalRecruiting
  • Osaka International Cancer InstituteRecruiting
  • Kindai University HospitalRecruiting
  • Saitama Medical University International Medical CenterRecruiting
  • Shizuoka Cancer CenterRecruiting
  • The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchRecruiting
  • Wakayama Medical University HospitalRecruiting
  • Chungbuk National University HospitalRecruiting
  • National Cancer CenterRecruiting
  • Gachon University Gil HospitalRecruiting
  • Gyeongsang National University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Severance Hospital Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Ulsan University HospitalRecruiting
  • Hospital Tengku Ampuan AfzanRecruiting
  • Sarawak General HospitalRecruiting
  • National Cancer Centre SingaporeRecruiting
  • Tan Tock Seng HospitalRecruiting
  • Kantonsspital GraubuendenRecruiting
  • Hopitaux universitaires de GeneveRecruiting
  • Kantonsspital Sankt GallenRecruiting
  • Kantonsspital WinterthurRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Memorial Ankara HastanesiRecruiting
  • Ankara Bilkent Sehir HastanesiRecruiting
  • Pamukkale Universitesi Tip Fakultesi HastanesiRecruiting
  • Medipol Mega Universite HastanesiRecruiting
  • Goztepe Prof Dr Suleyman Yalcin Sehir HastanesiRecruiting
  • Izmir Ekonomi Universitesi Medical Point HastanesiRecruiting
  • Inonu Universitesi Turgut Ozal Tip MerkeziRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tarlatamab

Standard of Care

Arm Description

Participants will receive tarlatamab as an intravenous (IV) infusion.

Participants will receive treatment per local standard of care (SOC).

Outcomes

Primary Outcome Measures

Overall Survival (OS)

Secondary Outcome Measures

Progression Free Survival (PFS)
Change from Baseline In Selected Functional Scales and Disease Symptom Items Included in Cancer Quality of Life Questionnaire
Change from Baseline in Selected Disease Symptoms Included in Lung Cancer Quality of Life Questionnaire
Overall Response (OR)
Disease Control (DC)
Duration of Response (DOR)
PFS
OS
Incidence of Treatment-Emergent Adverse Events (TEAE)
Serum Concentrations of Tarlatamab
Number of Participants Who Experience Anti-tarlatamab Antibodies
Change from Baseline in Pain Questionnaire
Patient Perceived Health at Each Assessment Visit Using Visual Analogue Scale (VAS)
Change from Baseline in Patient Perceived Health Using VAS
Responses to Patient-Reported Adverse Events Questionnaire
Change from Baseline in Patient Reported Symptom Severity
Change from Baseline of Overall Symptoms and Status in Patient Reported Impression of Change Questionnaire
Change from Baseline in Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire

Full Information

First Posted
February 7, 2023
Last Updated
October 12, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05740566
Brief Title
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
Acronym
DeLLphi-304
Official Title
A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
November 13, 2024 (Anticipated)
Study Completion Date
September 14, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer (SCLC)
Keywords
Small Cell Lung Cancer, SCLC, AMG 757, Tarlatamab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tarlatamab
Arm Type
Experimental
Arm Description
Participants will receive tarlatamab as an intravenous (IV) infusion.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Participants will receive treatment per local standard of care (SOC).
Intervention Type
Drug
Intervention Name(s)
Tarlatamab
Other Intervention Name(s)
AMG 757
Intervention Description
Tarlatamab will be administered as an IV infusion.
Intervention Type
Drug
Intervention Name(s)
Lurbinectedin
Intervention Description
Lurbinectedin will be administered per local SOC.
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Topotecan will be administered per local SOC.
Intervention Type
Drug
Intervention Name(s)
Amrubicin
Intervention Description
Amrubicin will be administered per local SOC.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Up to approximately 5 years
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
Up to approximately 5 years
Title
Change from Baseline In Selected Functional Scales and Disease Symptom Items Included in Cancer Quality of Life Questionnaire
Time Frame
Up to approximately 5 years
Title
Change from Baseline in Selected Disease Symptoms Included in Lung Cancer Quality of Life Questionnaire
Time Frame
Up to approximately 5 years
Title
Overall Response (OR)
Time Frame
Up to approximately 5 years
Title
Disease Control (DC)
Time Frame
Up to approximately 5 years
Title
Duration of Response (DOR)
Time Frame
Up to approximately 5 years
Title
PFS
Time Frame
1 year
Title
OS
Time Frame
1 year, 2 years and 3 years
Title
Incidence of Treatment-Emergent Adverse Events (TEAE)
Time Frame
Up to approximately 5 years
Title
Serum Concentrations of Tarlatamab
Time Frame
Up to 1 year
Title
Number of Participants Who Experience Anti-tarlatamab Antibodies
Time Frame
Up to 1 year
Title
Change from Baseline in Pain Questionnaire
Time Frame
Up to approximately 6 months
Title
Patient Perceived Health at Each Assessment Visit Using Visual Analogue Scale (VAS)
Time Frame
Up to approximately 5 years
Title
Change from Baseline in Patient Perceived Health Using VAS
Time Frame
Up to approximately 5 years
Title
Responses to Patient-Reported Adverse Events Questionnaire
Time Frame
Up to approximately 5 years
Title
Change from Baseline in Patient Reported Symptom Severity
Time Frame
Up to approximately 5 years
Title
Change from Baseline of Overall Symptoms and Status in Patient Reported Impression of Change Questionnaire
Time Frame
Up to approximately 5 years
Title
Change from Baseline in Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Time Frame
Up to approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 relapsed/refractory SCLC. Participants who progressed or recurred following 1 platinum-based regimen. Provision of evaluable tumor sample for central testing. 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 Untreated or 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. Exclusion of HIV and hepatitis 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. 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, or mixed SCLC NSCLC histology. Other Exclusions Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 72 days after the last dose of tarlatamab. Female participants who are breastfeeding or who plan to breastfeed while on study through 72 days after the last dose of tarlatamab. Female participants planning to become pregnant or donate eggs while on study through 72 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 132 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 132 days after the last dose of tarlatamab. Male participants unwilling to abstain from donating sperm during treatment and for an additional 132 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana U Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Pikeville Medical Center
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
Individual Site Status
Recruiting
Facility Name
Our Lady of the Lake Cancer Institute
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Name
Trinity Health Saint Joseph Mercy Ann Arbor
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee Medical Center Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Recruiting
Facility Name
Cemic
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Argentino de Diagnostico y Tratamiento IADT
City
Buenos Aires
ZIP/Postal Code
C1122AAL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
Calvary Mater Newcastle Hospital
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hospital de Base de Sao Jose do Rio Preto
City
São José do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Army Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Recruiting
Facility Name
Fuzhou General Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangmen Central Hospital
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529030
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325015
Country
China
Individual Site Status
Recruiting
Facility Name
Taizhou Peoples Hospital
City
Linhai
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Name
Hadassah Ein-Kerem Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Cancer Center
City
Akashi-shi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sendai Kousei Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata Cancer Center Hospital
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kansai Medical University Hospital
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University International Medical Center
City
Hidaka-Shi
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Wakayama Medical University Hospital
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chungbuk National University Hospital
City
Cheongju, Chungbuk
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-si Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Hospital
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gyeongsang National University Hospital
City
Jinju-si
ZIP/Postal Code
52727
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan
State/Province
Pahang
ZIP/Postal Code
25100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Sarawak General Hospital
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Kantonsspital Graubuenden
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Hopitaux universitaires de Geneve
City
Geneve 14
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kantonsspital Sankt Gallen
City
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Pamukkale Universitesi Tip Fakultesi Hastanesi
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medipol Mega Universite Hastanesi
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Izmir Ekonomi Universitesi Medical Point Hastanesi
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Inonu Universitesi Turgut Ozal Tip Merkezi
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

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Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

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