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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05740566




Registration number
NCT05740566
Ethics application status
Date submitted
7/02/2023
Date registered
23/02/2023

Titles & IDs
Public title
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
20210004
Universal Trial Number (UTN)
Trial acronym
DeLLphi-304
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer (SCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Tarlatamab
Treatment: Drugs - Lurbinectedin
Treatment: Drugs - Topotecan
Treatment: Drugs - Amrubicin

Experimental: Tarlatamab - Participants will receive tarlatamab as an intravenous (IV) infusion.

Active comparator: Standard of Care - Participants will receive treatment per local standard of care (SOC).


Treatment: Drugs: Tarlatamab
Tarlatamab will be administered as an IV infusion.

Treatment: Drugs: Lurbinectedin
Lurbinectedin will be administered per local SOC.

Treatment: Drugs: Topotecan
Topotecan will be administered per local SOC.

Treatment: Drugs: Amrubicin
Amrubicin will be administered per local SOC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 4 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 4 years
Secondary outcome [2] 0 0
Change from Baseline In Selected Functional Scales and Disease Symptom Items Included in Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [2] 0 0
Up to approximately 4 years
Secondary outcome [3] 0 0
Change from Baseline in Selected Disease Symptoms Included in Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13)
Timepoint [3] 0 0
Up to approximately 4 years
Secondary outcome [4] 0 0
Overall Response (OR)
Timepoint [4] 0 0
Up to approximately 4 years
Secondary outcome [5] 0 0
Disease Control (DC)
Timepoint [5] 0 0
Up to approximately 4 years
Secondary outcome [6] 0 0
Duration of Response (DOR)
Timepoint [6] 0 0
Up to approximately 4 years
Secondary outcome [7] 0 0
PFS
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
OS
Timepoint [8] 0 0
1 year, 2 years and 3 years
Secondary outcome [9] 0 0
Incidence of Treatment-Emergent Adverse Events (TEAE)
Timepoint [9] 0 0
Up to approximately 4 years
Secondary outcome [10] 0 0
Serum Concentrations of Tarlatamab
Timepoint [10] 0 0
Up to 1 year
Secondary outcome [11] 0 0
Number of Participants Who Experience Anti-tarlatamab Antibodies
Timepoint [11] 0 0
Up to 1 year
Secondary outcome [12] 0 0
Change from Baseline in Pain Severity as Measured by Brief Pain Inventory - Short Form (BPI-SF)
Timepoint [12] 0 0
Up to approximately 4 years
Secondary outcome [13] 0 0
Patient Perceived Health at Each Assessment Visit Using Visual Analogue Scale (VAS)
Timepoint [13] 0 0
Up to approximately 4 years
Secondary outcome [14] 0 0
Change from Baseline in Patient Perceived Health Using Visual Analog Scale (VAS)
Timepoint [14] 0 0
Up to approximately 4 years
Secondary outcome [15] 0 0
Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)
Timepoint [15] 0 0
Up to approximately 4 years
Secondary outcome [16] 0 0
Change from Baseline in Symptom Severity as Measured by Patient Global Impression of Severity (PGIS) Questionnaire
Timepoint [16] 0 0
Up to approximately 4 years
Secondary outcome [17] 0 0
Change from Baseline in Symptoms and Overall Status as Measured by Patient Reported Impression of Change (PGIC) Questionnaire
Timepoint [17] 0 0
Up to approximately 4 years
Secondary outcome [18] 0 0
Change from Baseline in Symptom Bother as Measured by Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Timepoint [18] 0 0
Up to approximately 4 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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..

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
Accrual to date
Final
509
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
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California
Country [5] 0 0
United States of America
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Illinois
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United States of America
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Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
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Michigan
Country [11] 0 0
United States of America
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Minnesota
Country [12] 0 0
United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
South Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Córdoba
Country [23] 0 0
Argentina
State/province [23] 0 0
Río Negro
Country [24] 0 0
Argentina
State/province [24] 0 0
Santa Fe
Country [25] 0 0
Austria
State/province [25] 0 0
Graz
Country [26] 0 0
Austria
State/province [26] 0 0
Krems
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Belgium
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Hasselt
Country [29] 0 0
Belgium
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Roeselare
Country [30] 0 0
Belgium
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Sint-Niklaas
Country [31] 0 0
Brazil
State/province [31] 0 0
Bahia
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Brazil
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Rio Grande Do Norte
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Brazil
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Rio Grande Do Sul
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Brazil
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Rondônia
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Canada
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Ontario
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China
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Anhui
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China
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Beijing
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China
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Chongqing
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China
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Fujian
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China
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Guangdong
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China
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Hebei
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China
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Heilongjiang
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
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Shandong
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China
State/province [51] 0 0
Shanghai
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China
State/province [52] 0 0
Shanxi
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China
State/province [53] 0 0
Sichuan
Country [54] 0 0
China
State/province [54] 0 0
Zhejiang
Country [55] 0 0
China
State/province [55] 0 0
Fuzhou
Country [56] 0 0
China
State/province [56] 0 0
Tianjin
Country [57] 0 0
China
State/province [57] 0 0
Weihai
Country [58] 0 0
Czechia
State/province [58] 0 0
Brno
Country [59] 0 0
Czechia
State/province [59] 0 0
Olomouc
Country [60] 0 0
Czechia
State/province [60] 0 0
Ostrava-Vitkovice
Country [61] 0 0
Czechia
State/province [61] 0 0
Praha 2
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Denmark
State/province [62] 0 0
Copenhagen
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France
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Grenoble
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France
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Lille Cedex
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France
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Limoges Cedex
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France
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Lyon
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France
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Marseille Cedex 20
Country [68] 0 0
France
State/province [68] 0 0
Paris
Country [69] 0 0
France
State/province [69] 0 0
Pierre-Benite cedex
Country [70] 0 0
France
State/province [70] 0 0
Rennes Cedex 9
Country [71] 0 0
France
State/province [71] 0 0
Strasbourg Cedex
Country [72] 0 0
France
State/province [72] 0 0
Toulouse Cedex 9
Country [73] 0 0
France
State/province [73] 0 0
Villejuif
Country [74] 0 0
Germany
State/province [74] 0 0
Berlin
Country [75] 0 0
Germany
State/province [75] 0 0
Dresden
Country [76] 0 0
Germany
State/province [76] 0 0
Essen
Country [77] 0 0
Germany
State/province [77] 0 0
Gauting
Country [78] 0 0
Germany
State/province [78] 0 0
Grosshansdorf
Country [79] 0 0
Germany
State/province [79] 0 0
Koeln
Country [80] 0 0
Germany
State/province [80] 0 0
Stuttgart
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Germany
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Wuerzburg
Country [82] 0 0
Greece
State/province [82] 0 0
Athens
Country [83] 0 0
Greece
State/province [83] 0 0
Heraklion - Crete
Country [84] 0 0
Greece
State/province [84] 0 0
Patra
Country [85] 0 0
Greece
State/province [85] 0 0
Thessaloniki
Country [86] 0 0
Hungary
State/province [86] 0 0
Budapest
Country [87] 0 0
Hungary
State/province [87] 0 0
Gyongyos
Country [88] 0 0
Hungary
State/province [88] 0 0
Szekesfehervar
Country [89] 0 0
Hungary
State/province [89] 0 0
Tatabanya
Country [90] 0 0
Hungary
State/province [90] 0 0
Torokbalint
Country [91] 0 0
Ireland
State/province [91] 0 0
Dublin
Country [92] 0 0
Israel
State/province [92] 0 0
Haifa
Country [93] 0 0
Israel
State/province [93] 0 0
Jerusalem
Country [94] 0 0
Israel
State/province [94] 0 0
Kfar Saba
Country [95] 0 0
Israel
State/province [95] 0 0
Petah Tikva
Country [96] 0 0
Italy
State/province [96] 0 0
Bergamo
Country [97] 0 0
Italy
State/province [97] 0 0
Catanzaro
Country [98] 0 0
Italy
State/province [98] 0 0
Genova
Country [99] 0 0
Italy
State/province [99] 0 0
Meldola (FC)
Country [100] 0 0
Italy
State/province [100] 0 0
Orbassano
Country [101] 0 0
Italy
State/province [101] 0 0
Roma
Country [102] 0 0
Japan
State/province [102] 0 0
Aichi
Country [103] 0 0
Japan
State/province [103] 0 0
Chiba
Country [104] 0 0
Japan
State/province [104] 0 0
Ehime
Country [105] 0 0
Japan
State/province [105] 0 0
Fukuoka
Country [106] 0 0
Japan
State/province [106] 0 0
Hokkaido
Country [107] 0 0
Japan
State/province [107] 0 0
Hyogo
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Japan
State/province [108] 0 0
Kanagawa
Country [109] 0 0
Japan
State/province [109] 0 0
Miyagi
Country [110] 0 0
Japan
State/province [110] 0 0
Niigata
Country [111] 0 0
Japan
State/province [111] 0 0
Okayama
Country [112] 0 0
Japan
State/province [112] 0 0
Osaka
Country [113] 0 0
Japan
State/province [113] 0 0
Saitama
Country [114] 0 0
Japan
State/province [114] 0 0
Shizuoka
Country [115] 0 0
Japan
State/province [115] 0 0
Tokyo
Country [116] 0 0
Japan
State/province [116] 0 0
Wakayama
Country [117] 0 0
Korea, Republic of
State/province [117] 0 0
Cheongju Chungbuk
Country [118] 0 0
Korea, Republic of
State/province [118] 0 0
Goyang-si Gyeonggi-do
Country [119] 0 0
Korea, Republic of
State/province [119] 0 0
Incheon
Country [120] 0 0
Korea, Republic of
State/province [120] 0 0
Jinju-si
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Seongnam-si, Gyeonggi-do
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Seoul
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Ulsan
Country [124] 0 0
Malaysia
State/province [124] 0 0
Pahang
Country [125] 0 0
Malaysia
State/province [125] 0 0
Sarawak
Country [126] 0 0
Malaysia
State/province [126] 0 0
Wilayah Persekutuan
Country [127] 0 0
Mexico
State/province [127] 0 0
Distrito Federal
Country [128] 0 0
Mexico
State/province [128] 0 0
Jalisco
Country [129] 0 0
Netherlands
State/province [129] 0 0
Groningen
Country [130] 0 0
Netherlands
State/province [130] 0 0
Leiden
Country [131] 0 0
Netherlands
State/province [131] 0 0
Rotterdam
Country [132] 0 0
Netherlands
State/province [132] 0 0
Utrecht
Country [133] 0 0
Poland
State/province [133] 0 0
Bystra
Country [134] 0 0
Poland
State/province [134] 0 0
Krakow
Country [135] 0 0
Poland
State/province [135] 0 0
Poznan
Country [136] 0 0
Portugal
State/province [136] 0 0
Lisboa
Country [137] 0 0
Portugal
State/province [137] 0 0
Matosinhos
Country [138] 0 0
Portugal
State/province [138] 0 0
Porto
Country [139] 0 0
Romania
State/province [139] 0 0
Cluj Napoca
Country [140] 0 0
Romania
State/province [140] 0 0
Craiova
Country [141] 0 0
Romania
State/province [141] 0 0
Iasi
Country [142] 0 0
Romania
State/province [142] 0 0
Timisoara
Country [143] 0 0
Singapore
State/province [143] 0 0
Singapore
Country [144] 0 0
Spain
State/province [144] 0 0
Andalucía
Country [145] 0 0
Spain
State/province [145] 0 0
Aragón
Country [146] 0 0
Spain
State/province [146] 0 0
Cataluña
Country [147] 0 0
Spain
State/province [147] 0 0
Galicia
Country [148] 0 0
Spain
State/province [148] 0 0
Madrid
Country [149] 0 0
Switzerland
State/province [149] 0 0
Chur
Country [150] 0 0
Switzerland
State/province [150] 0 0
Fribourg
Country [151] 0 0
Switzerland
State/province [151] 0 0
Geneve 14
Country [152] 0 0
Switzerland
State/province [152] 0 0
Sankt Gallen
Country [153] 0 0
Switzerland
State/province [153] 0 0
Winterthur
Country [154] 0 0
Taiwan
State/province [154] 0 0
Kaohsiung
Country [155] 0 0
Taiwan
State/province [155] 0 0
Taichung
Country [156] 0 0
Taiwan
State/province [156] 0 0
Tainan
Country [157] 0 0
Taiwan
State/province [157] 0 0
Taipei
Country [158] 0 0
Turkey
State/province [158] 0 0
Ankara
Country [159] 0 0
Turkey
State/province [159] 0 0
Denizli
Country [160] 0 0
Turkey
State/province [160] 0 0
Istanbul
Country [161] 0 0
Turkey
State/province [161] 0 0
Izmir
Country [162] 0 0
Turkey
State/province [162] 0 0
Malatya
Country [163] 0 0
United Kingdom
State/province [163] 0 0
London
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05740566