Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2026-03-01 @ 7:58 AM
Study NCT ID:
NCT05361395
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2022-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'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'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722655', 'term': 'AMG 757'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'C000613593', 'term': 'durvalumab'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT06064500', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-08-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-04-29', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with a Dose Limiting Toxicity (DLT)', 'timeFrame': '24 months'}, {'measure': 'Number of Participants with Treatment-emergent Adverse Events (TEAE)', 'timeFrame': '24 months'}, {'measure': 'Number of Participants with Treatment-related Adverse Events', 'timeFrame': '24 months'}, {'measure': 'Number of Participants with Clinically Significant Changes in Vital Signs', 'timeFrame': '24 months'}, {'measure': 'Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements', 'timeFrame': '24 months'}, {'measure': 'Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': '6-month Progression-free Survival (PFS)', 'timeFrame': '24 months'}, {'measure': 'Objective Response (OR)', 'timeFrame': '24 months', 'description': 'Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': '24 months'}, {'measure': 'Disease Control Rate(DCR)', 'timeFrame': '24 months'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '24 months'}, {'measure': 'Serum Concentration of Tarlatamab', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extensive Stage Small Cell Lung Cancer', 'ES-SCLC', 'SCLC', 'Lung Cancer', 'AMG 757', 'Bi-Specific T-Cell Engager', 'BiTE', 'Inmunotherapy', 'Immunooncology', 'Inmuno-oncology', 'DLL3', 'Delta Like Protein 3'], 'conditions': ['Extensive Stage Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40934933', 'type': 'BACKGROUND', 'citation': 'Paulson KG, Lau SCM, Ahn MJ, Moskovitz M, Pogorzelski M, Hafliger S, Parkes A, Zhang Y, Hamidi A, Thompson CG, Wermke M. Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): a multicentre, non-randomised, phase 1b study. Lancet Oncol. 2025 Oct;26(10):1300-1311. doi: 10.1016/S1470-2045(25)00480-2. Epub 2025 Sep 8.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.'}, '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 greater than or equal to 18 years old at the same time of signing the informed consent.\n* Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.\n* Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.\n* Eastern Cooperative Oncology Group (ECOG) 0 to 1.\n* Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.\n* Adequate organ function as defined in protocol.\n\nExclusion Criteria:\n\n* History of other malignancy within the past 2 years with exceptions.\n* Major surgery within 28 days of study day 1.\n* Untreated or symptomatic brain metastases and leptomeningeal disease.\n* Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.\n* History of immune-related colitis.\n* History or evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.\n* Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment\n* Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint\n* NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for \\>24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required.\n* History of hypophysitis or pituitary dysfunction.\n* History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.'}, 'identificationModule': {'nctId': 'NCT05361395', 'briefTitle': 'First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung (DeLLphi-303)', 'orgStudyIdInfo': {'id': '20200469'}, 'secondaryIdInfos': [{'id': '2024-511021-58', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Dose Exploration Combination Regimen 1', 'description': 'Tarlatamab+Atezolizumab+Carboplatin+Etoposide', 'interventionNames': ['Drug: Tarlatamab', 'Drug: Carboplatin', 'Drug: Etoposide', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Dose Exploration Combination Regimen 2', 'description': 'Tarlatamab+Atezolizumab+Carboplatin+Etoposide', 'interventionNames': ['Drug: Tarlatamab', 'Drug: Carboplatin', 'Drug: Etoposide', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: Dose Exploration Combination Regimen 3', 'description': 'Tarlatamab+Atezolizumab+Carboplatin+Etoposide', 'interventionNames': ['Drug: Tarlatamab', 'Drug: Carboplatin', 'Drug: Etoposide', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4: Dose Expansion', 'description': 'Expansion of Part 1, Part 2, or Part 3 with Atezolizumab', 'interventionNames': ['Drug: Tarlatamab', 'Drug: Carboplatin', 'Drug: Etoposide', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 5: Dose Exploration Maintenance', 'description': 'Tarlatamab+Atezolizumab', 'interventionNames': ['Drug: Tarlatamab', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 6: Dose Expansion Maintenance', 'description': 'Expansion of Part 5 with Atezolizumab', 'interventionNames': ['Drug: Tarlatamab', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 7: Dose Expansion', 'description': 'Expansion of Part 1, 2, or 3 with Durvalumab', 'interventionNames': ['Drug: Tarlatamab', 'Drug: Carboplatin', 'Drug: Etoposide', 'Drug: Durvalumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 8: Dose Expansion Maintenance', 'description': 'Expansion of Part 5 with Durvalumab', 'interventionNames': ['Drug: Tarlatamab', 'Drug: Durvalumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 9: Dose Expansion Maintenance', 'description': 'Expansion with Tarlatamab+Durvalumab', 'interventionNames': ['Drug: Tarlatamab', 'Drug: Durvalumab']}], 'interventions': [{'name': 'Tarlatamab', 'type': 'DRUG', 'otherNames': ['AMG 757'], 'description': 'Tarlatamab will be administered as an intravenous (IV) infusion.', 'armGroupLabels': ['Part 1: Dose Exploration Combination Regimen 1', 'Part 2: Dose Exploration Combination Regimen 2', 'Part 3: Dose Exploration Combination Regimen 3', 'Part 4: Dose Expansion', 'Part 5: Dose Exploration Maintenance', 'Part 6: Dose Expansion Maintenance', 'Part 7: Dose Expansion', 'Part 8: Dose Expansion Maintenance', 'Part 9: Dose Expansion Maintenance']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin will be administered as an intravenous (IV) infusion.', 'armGroupLabels': ['Part 1: Dose Exploration Combination Regimen 1', 'Part 2: Dose Exploration Combination Regimen 2', 'Part 3: Dose Exploration Combination Regimen 3', 'Part 4: Dose Expansion', 'Part 7: Dose Expansion']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Etoposide will be administered as an intravenous (IV) infusion.', 'armGroupLabels': ['Part 1: Dose Exploration Combination Regimen 1', 'Part 2: Dose Exploration Combination Regimen 2', 'Part 3: Dose Exploration Combination Regimen 3', 'Part 4: Dose Expansion', 'Part 7: Dose Expansion']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['Tecentriq'], 'description': 'Atezolizumab will be administered as an intravenous (IV) infusion.', 'armGroupLabels': ['Part 1: Dose Exploration Combination Regimen 1', 'Part 2: Dose Exploration Combination Regimen 2', 'Part 3: Dose Exploration Combination Regimen 3', 'Part 4: Dose Expansion', 'Part 5: Dose Exploration Maintenance', 'Part 6: Dose Expansion Maintenance']}, {'name': 'Durvalumab', 'type': 'DRUG', 'description': 'Durvalumab will be administered as an intravenous (IV) infusion.', 'armGroupLabels': ['Part 7: Dose Expansion', 'Part 8: Dose Expansion Maintenance', 'Part 9: Dose Expansion Maintenance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California, Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'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': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera Cancer Institute', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute Medical Oncology', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Health Sciences Center', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Chris OBrien Lifehouse', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis - Campus Virga Jesse', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ Delta Campus Rumbeke', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU de Quebec Hopital de l Enfant Jesus', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '44800', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitaetsklinikum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitaetsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '9112001', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Ein-Kerem Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '4941492', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '5265601', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Renato Dulbecco', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '20900', 'city': 'Monza (MB)', 'country': 'Italy', 'facility': 'Fondazione IRCCS San Gerardo dei Tintori', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': 'Istituto Nazionale Tumori Regina Elena', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '277-8577', 'city': 'Kashiwa-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East'}, {'zip': '135-8550', 'city': 'Koto-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'The Cancer Institute Hospital of Japanese Foundation for Cancer Research'}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Universitari Vall d Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitaetsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '70403', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': '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'}}}}