Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-01 @ 2:58 PM
Study NCT ID:
NCT05740566
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2023-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-12'}], 'estimatedResultsFirstSubmitDate': '2025-12-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722655', 'term': 'AMG 757'}, {'id': 'C568606', 'term': 'PM 01183'}, {'id': 'D019772', 'term': 'Topotecan'}, {'id': 'C055866', 'term': 'amrubicin'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 509}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT06064500', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-03-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 4 years'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Change from Baseline In Selected Functional Scales and Disease Symptom Items Included in Cancer Quality of Life Questionnaire (EORTC QLQ-C30)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Change from Baseline in Selected Disease Symptoms Included in Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Overall Response (OR)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Disease Control (DC)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'PFS', 'timeFrame': '1 year'}, {'measure': 'OS', 'timeFrame': '1 year, 2 years and 3 years'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events (TEAE)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Serum Concentrations of Tarlatamab', 'timeFrame': 'Up to 1 year'}, {'measure': 'Number of Participants Who Experience Anti-tarlatamab Antibodies', 'timeFrame': 'Up to 1 year'}, {'measure': 'Change from Baseline in Pain Severity as Measured by Brief Pain Inventory - Short Form (BPI-SF)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Patient Perceived Health at Each Assessment Visit Using Visual Analogue Scale (VAS)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Change from Baseline in Patient Perceived Health Using Visual Analog Scale (VAS)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Change from Baseline in Symptom Severity as Measured by Patient Global Impression of Severity (PGIS) Questionnaire', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Change from Baseline in Symptoms and Overall Status as Measured by Patient Reported Impression of Change (PGIC) Questionnaire', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Change from Baseline in Symptom Bother as Measured by Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire', 'timeFrame': 'Up to approximately 4 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Small Cell Lung Cancer', 'SCLC', 'AMG 757', 'Tarlatamab'], 'conditions': ['Small Cell Lung Cancer (SCLC)']}, 'referencesModule': {'references': [{'pmid': '40454646', 'type': 'BACKGROUND', 'citation': 'Mountzios G, Sun L, Cho BC, Demirci U, Baka S, Gumus M, Lugini A, Zhu B, Yu Y, Korantzis I, Han JY, Ciuleanu TE, Ahn MJ, Rocha P, Mazieres J, Lau SCM, Schuler M, Blackhall F, Yoshida T, Owonikoko TK, Paz-Ares L, Jiang T, Hamidi A, Gauto D, Recondo G, Rudin CM; DeLLphi-304 Investigators. Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. N Engl J Med. 2025 Jul 24;393(4):349-361. doi: 10.1056/NEJMoa2502099. Epub 2025 Jun 2.'}, {'pmid': '39530627', 'type': 'DERIVED', 'citation': 'Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Alvarez JB, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L. Plain language summary: tarlatamab for patients with previously treated small cell lung cancer. Future Oncol. 2024 Dec;20(40):3355-3364. doi: 10.1080/14796694.2024.2402152. Epub 2024 Nov 12.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has provided informed consent prior to initiation of any study specific activities/procedures.\n* Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.\n* Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.\n* Participants who progressed or recurred following 1 platinum-based regimen.\n* Measurable disease as defined per RECIST 1.1 within the 21-day screening period.\n* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.\n* Minimum life expectancy of 12 weeks.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Disease Related\n\n * Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.\n * Diagnosis or evidence of leptomeningeal disease.\n * Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.\n* Other Medical Conditions\n\n * Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy.\n * History of solid organ transplantation.\n * History of other malignancy within the past 2 years, with exceptions defined in the protocol.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \\> class II) within 12 months prior to first dose of study treatment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.\n * Presence or history of viral infection based on criteria per protocol.\n * Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.\n * 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.\n * Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* Prior/Concomitant Therapy\n\n * 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.\n * Prior therapy with any selective inhibitor of the DLL3 pathway.\n * Participant received more than one prior systemic therapy regimen for SCLC.\n * Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.\n * Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.\n * 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.\n * 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.\n * 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.\n * Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.\n * Major surgical procedures within 28 days prior to first dose of study treatment.\n * Live and live-attenuated vaccines within 14 days prior to the start of study treatment.\n * Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.\n * 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.\n* Diagnostic Assessments\n\n * 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.\n* Other Exclusions\n\n * 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.\n * Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.\n * Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab.\n * Female participants of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test.\n * 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.\n * 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.\n * Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.\n * Contraception requirements for male and female participants receiving SOC therapies are based on regional prescribing information.\n * Breastfeeding restrictions for female participants receiving SOC therapies are based on regional prescribing information.\n * Participant has known sensitivity or is contraindicated to any of the products or components to be administered during dosing.\n * Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures.\n * 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..'}, 'identificationModule': {'nctId': 'NCT05740566', 'acronym': 'DeLLphi-304', 'briefTitle': 'Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '20210004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tarlatamab', 'description': 'Participants will receive tarlatamab as an intravenous (IV) infusion.', 'interventionNames': ['Drug: Tarlatamab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Participants will receive treatment per local standard of care (SOC).', 'interventionNames': ['Drug: Lurbinectedin', 'Drug: Topotecan', 'Drug: Amrubicin']}], 'interventions': [{'name': 'Tarlatamab', 'type': 'DRUG', 'otherNames': ['AMG 757'], 'description': 'Tarlatamab will be administered as an IV infusion.', 'armGroupLabels': ['Tarlatamab']}, {'name': 'Lurbinectedin', 'type': 'DRUG', 'description': 'Lurbinectedin will be administered per local SOC.', 'armGroupLabels': ['Standard of Care']}, {'name': 'Topotecan', 'type': 'DRUG', 'description': 'Topotecan will be administered per local SOC.', 'armGroupLabels': ['Standard of Care']}, {'name': 'Amrubicin', 'type': 'DRUG', 'description': 'Amrubicin will be administered per local SOC.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Oncology and Hematology', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 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'55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Health Care', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '91010', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Summit Medical Group, Overlook Oncology Center', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Grossman School of Medicine and New York University Langone Hospitals', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Perlmutter Cancer Center at New York University Langone Hospital----Long Island', 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'lon': -83.92074}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Cancer Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98026', 'city': 'Edmonds', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute Medical Oncology', 'geoPoint': {'lat': 47.81065, 'lon': -122.37736}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'C1431FWO', 'city': 'Ciudad Autonoma de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Cemic'}, {'zip': 'B1629ODT', 'city': 'Pilar', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Universitario Austral', 'geoPoint': {'lat': -34.45867, 'lon': -58.91398}}, {'zip': 'X5004BAL', 'city': 'Córdoba', 'state': 'Córdoba Province', 'country': 'Argentina', 'facility': 'Sociedad de Beneficencia Hospital Italiano', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'R8500ACE', 'city': 'Viedma', 'state': 'Río Negro Province', 'country': 'Argentina', 'facility': 'Clinica Viedma', 'geoPoint': {'lat': -40.81519, 'lon': -63.0004}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Sanatorio Parque SA', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'C1122AAL', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto Argentino de Diagnostico y Tratamiento IADT', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'X5000JHQ', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Sanatorio Allende', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '2298', 'city': 'Waratah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Calvary Mater Newcastle Hospital', 'geoPoint': {'lat': -32.90667, 'lon': 151.72647}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medizinische Universitaet Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '3500', 'city': 'Krems', 'country': 'Austria', 'facility': 'Universitaetsklinikum Krems', 'geoPoint': {'lat': 48.40921, 'lon': 15.61415}}, {'zip': '9000', 'city': 'Ghent', 'country': 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'country': 'Brazil', 'facility': 'Liga Norte-Riograndense Contra O Cancer', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}, {'zip': '98700-000', 'city': 'Ijuí', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda', 'geoPoint': {'lat': -28.38778, 'lon': -53.91472}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '76834-899', 'city': 'Porto Velho', 'state': 'Rondônia', 'country': 'Brazil', 'facility': 'Hospital de Amor da Amazonia', 'geoPoint': {'lat': -8.76194, 'lon': -63.90389}}, {'zip': '15090-000', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital de Base de Sao Jose do Rio Preto', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '01323-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Beneficencia Portuguesa de Sao Paulo - Bp', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04502-001', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Oncologia Rede D Or', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '22793-080', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto Coi', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01246-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 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'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}