Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT04933695
Status:
COMPLETED
Last Update Posted:
2025-10-22
First Post:
2021-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'C000706028', 'term': 'sotorasib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04667234', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (OR)', 'timeFrame': 'Up to 6 years', 'description': 'OR is defined as the total of Complete Response (CR) and Partial Response (PR).'}], 'secondaryOutcomes': [{'measure': 'Disease Control Rate', 'timeFrame': 'Up to 6 years'}, {'measure': 'Duration of Reponse (DOR)', 'timeFrame': 'Up to 6 years'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'Up to 6 years'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to 6 years'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 6 years'}, {'measure': 'Number of Participants with a Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'Day 1 up to Month 13'}, {'measure': 'Number of Participants with a Treatment-related Adverse Event', 'timeFrame': 'Day 1 up to Month 13'}, {'measure': 'Number of Participants with a Clinically Significant Change from Baseline in Vital Signs', 'timeFrame': 'Baseline (Screening; up to 28 days pre-dose) up to Month 13'}, {'measure': 'Number of Participants with a Clinically Significant Change from Baseline in Electrocardiograms (ECGs)', 'timeFrame': 'Baseline (Screening; up to 28 days pre-dose) up to Month 13'}, {'measure': 'Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests', 'timeFrame': 'Baseline (Screening; up to 28 days pre-dose) up to Month 13'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Sotorasib', 'timeFrame': 'Day 1 up to Month 3'}, {'measure': 'Time to Reach Maximum Plasma Concentration (tmax) of Sotorasib', 'timeFrame': 'Day 1 up to Month 3'}, {'measure': 'Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib', 'timeFrame': 'Day 1 up to Month 3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer', 'KRAS p.G12C', 'Sotorasib', 'AMG 510'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) \\< 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 \\< 1% and in a subgroup of participants with STK11 co-mutation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (= or \\> 18 years old) with NSCLC\n* Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage IV disease\n* Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)\n* Programmed death-ligand 1 (PD-L1) TPS Score \\< 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation)\n* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n* No active brain metastases\n* Measurable disease per investigator interpretation using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria\n\nExclusion Criteria:\n\n* Mixed small-cell lung cancer and NSCLC histology\n* Myocardial Infarction within 6 months of study Day 1\n* Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonists (H2RA), strong inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) or known CYP3A4 sensitive substrates or P-gp substrates\n* Therapeutic or palliative radiation therapy within 2 weeks of study day 1\n* Unable to take oral medication\n* Unable to receive both iodinated contrast for computed tomography (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans'}, 'identificationModule': {'nctId': 'NCT04933695', 'acronym': 'CodeBreaK201', 'briefTitle': 'A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)', 'orgStudyIdInfo': {'id': '20190288'}, 'secondaryIdInfos': [{'id': '2021-002638-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sotorasib: 960 mg Daily', 'description': 'Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \\< 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 960 mg daily. Participants will be stratified by known presence of STK11 mutation.', 'interventionNames': ['Drug: Sotorasib']}, {'type': 'EXPERIMENTAL', 'label': 'Sotorasib: 240 mg Daily', 'description': 'Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \\< 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 240 mg daily. Participants will be stratified by known presence of STK11 mutation.', 'interventionNames': ['Drug: Sotorasib']}], 'interventions': [{'name': 'Sotorasib', 'type': 'DRUG', 'otherNames': ['AMG 510', 'LUMYKRAS', 'LUMAKRAS'], 'description': 'Oral tablet', 'armGroupLabels': ['Sotorasib: 240 mg Daily', 'Sotorasib: 960 mg Daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Oncology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates Professional Corporation', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope at Long Beach Elm', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist MD Anderson Cancer Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northwest Georgia Oncology Centers PC', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21702', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'Frederick Memorial Hospital', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Englewood Hospital and Medical Center', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'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': 'Laura and Isaac Perlmutter Cancer Center at New York University Langone', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11768', 'city': 'Northport', 'state': 'New York', 'country': 'United States', 'facility': 'Northport Veterans Affairs Medical Center', 'geoPoint': {'lat': 40.90093, 'lon': -73.34317}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'James J Peters VA Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center, Morris Cancer Clinic', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Health Network Cancer Institute at Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center Cancer Pavillion', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina, Hollings Cancer Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75230-2510', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Medical City Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75230-2510', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Plano East', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Dallas Presbyterian Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75234', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Flower Mound', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Baylor', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76201', 'city': 'Denton', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Denton', 'geoPoint': {'lat': 33.21484, 'lon': -97.13307}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Oncology Consultants PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75071', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology- Mckinney', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '75460-5004', 'city': 'Paris', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Northeast Texas', 'geoPoint': {'lat': 33.66094, 'lon': -95.55551}}, {'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gundersen Health System', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universite Catholique de Louvain Cliniques Universitaires Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis - Campus Virga Jesse', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire de Liege - Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5000', 'city': 'Odense C', 'country': 'Denmark', 'facility': 'Odense Universitetshospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '84918', 'city': 'Avignon', 'country': 'France', 'facility': 'Institut Sainte Catherine', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Montpellier - Val d Aurelle', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '44800', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Centre Hospitalier de Nantes - Hôpital Nord Laënnec', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '83056', 'city': 'Toulon', 'country': 'France', 'facility': 'Hôpital Sainte Musse', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Toulouse - Hopital Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '82130', 'city': 'Gauting', 'country': 'Germany', 'facility': 'Asklepios - Fachkliniken München-Gauting', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'zip': '20900', 'city': 'Monza (MB)', 'country': 'Italy', 'facility': 'Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '10043', 'city': 'Orbassano (TO)', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria San Luigi Gonzaga', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': 'Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '08003', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro Majadahonda', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '46026', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '801 87', 'city': 'Gävle', 'country': 'Sweden', 'facility': 'Gavle Sjukhus', 'geoPoint': {'lat': 60.67452, 'lon': 17.14174}}, {'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska Universitetssjukhuset', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '581 85', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Universitetssjukhuset i Linkoping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Skanes Universitetssjukhus', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Norrlands Universitetssjukhus', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': '06560', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '22030', 'city': 'Edirne', 'country': 'Turkey (Türkiye)', 'facility': 'Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}, {'zip': '34010', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Koc Universitesi Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], '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'}}}}