Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-30 @ 7:11 AM
Study NCT ID:
NCT05091567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-22
First Post:
2021-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-04', 'mcpReleaseN': 42, 'releaseDate': '2025-11-21'}, {'releaseDate': '2025-12-09'}], 'estimatedResultsFirstSubmitDate': '2025-11-21'}}, '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': 'C000594389', 'term': 'atezolizumab'}, {'id': 'C568606', 'term': 'PM 01183'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-08-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-10-12', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IRF-Assessed Progression-Free Survival (PFS)', 'timeFrame': 'Randomization to the date of first documented disease progression or death, whichever occurs first (up to approximately 60 months)', 'description': 'IRF-assessed progression-free survival (PFS) is defined as the time from randomization to the date of first documented disease progression (as assessed by the IRF according to RECIST v1.1), or death whichever occurs first.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Randomization to the date of death from any cause (up to approximately 60 months)', 'description': 'Overall survival (OS) is defined as the time from randomization to the date of death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Investigator-Assessed PFS', 'timeFrame': 'Randomization to the first occurrence of disease progression or death from any cause (whichever occurs first) (up to approximately 60 months)', 'description': 'Investigator-assessed PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).'}, {'measure': 'Confirmed Objective Response Rate (ORR) as Determined by the IRF', 'timeFrame': 'Up to approximately 60 months', 'description': 'Confirmed objective response rate (ORR) is defined as the proportion of randomized participants with a CR or PR on two consecutive occasions \\>= 4 weeks apart after randomization, as determined by the IRF according to RECIST v1.1.'}, {'measure': 'Confirmed Objective Response Rate (ORR) as Determined by the Investigator', 'timeFrame': 'Up to approximately 60 months', 'description': 'Confirmed objective response rate (ORR) is defined as the proportion of randomized participants with a CR or PR on two consecutive occasions \\>= 4 weeks apart after randomization, as determined by the Investigator according to RECIST v1.1.'}, {'measure': 'Duration of Response (DOR) as Determined by the IRF', 'timeFrame': 'Up to approximately 60 months', 'description': 'Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response after randomization until disease progression as determined by the IRF according to RECIST v1.1, or death from any cause, whichever occurs first.'}, {'measure': 'Duration of Response (DOR) as Determined by the Investigator', 'timeFrame': 'Up to approximately 60 months', 'description': 'Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response after randomization until disease progression as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first.'}, {'measure': 'PFS Rates as Determined by the IRF', 'timeFrame': '6 months and 12 months after randomization', 'description': 'PFS rates at 6 months and 12 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months and 12 months after randomization, as determined by the IRF according to RECIST v1.1.'}, {'measure': 'PFS Rates as Determined by the Investigator', 'timeFrame': '6 months and 12 months after randomization', 'description': 'PFS rates at 6 months and 12 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months and 12 months after randomization, as determined by the investigator according to RECIST v1.1.'}, {'measure': 'OS Rates', 'timeFrame': '12 months and 24 months after randomization', 'description': 'OS rates at 12 months and 24 months is defined as the proportion of participants who have not experienced death from any cause at 12 months and 24 months after randomization.'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Up to approximately 60 months', 'description': 'Percentage of participants with adverse events.'}, {'measure': 'Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab', 'timeFrame': 'Up to approximately 60 months', 'description': 'Percentage of participants with ADAs to atezolizumab after drug administration.'}, {'measure': 'Time to Confirmed Deterioration (TTCD)', 'timeFrame': 'Up to approximately 60 months', 'description': 'Time to confirmed deterioration (TTCD) from randomization in participant-reported physical functioning and global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small-Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40473449', 'type': 'DERIVED', 'citation': 'Paz-Ares L, Borghaei H, Liu SV, Peters S, Herbst RS, Stencel K, Majem M, Sendur MAN, Czyzewicz G, Caro RB, Lee KH, Johnson ML, Karadurmus N, Grohe C, Baka S, Csoszi T, Ahn JS, Califano R, Yang TY, Kemal Y, Ballinger M, Cuchelkar V, Graupner V, Lin YC, Chakrabarti D, Bhatt K, Cai G, Iannone R, Reck M; IMforte investigators. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2025 Jun 14;405(10495):2129-2143. doi: 10.1016/S0140-6736(25)01011-6. Epub 2025 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for the Induction Phase:\n\n* ECOG PS of 0 or 1\n* No prior systemic therapy for ES-SCLC\n* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC\n* Histologically or cytologically confirmed ES-SCLC\n* Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab\n* Measurable disease, as defined by RECIST v1.1\n* Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening\n\nExclusion Criteria for the Induction Phase:\n\n* Presence or history of CNS metastases\n* Active or history of autoimmune disease or deficiency\n* History of malignancies other than SCLC within 5 years prior to enrollment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Treatment with investigational therapy within 28 days prior to enrollment\n\nInclusion Criteria for the Maintenance Phase:\n\n* ECOG PS of 0 or 1\n* Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy\n* Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade \\<=1\n* Adequate hematologic and end-organ function\n\nExclusion Criteria for the Maintenance Phase:\n\n* Presence or history of CNS metastases\n* Receiving consolidative chest radiation\n* Severe infection within 2 weeks prior to randomization into the maintenance\n* Treatment with therapeutic oral or IV antibiotics at the time of randomization'}, 'identificationModule': {'nctId': 'NCT05091567', 'acronym': 'IMforte', 'briefTitle': 'A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab', 'orgStudyIdInfo': {'id': 'GO43104'}, 'secondaryIdInfos': [{'id': '2023-503868-16-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Atezolizumab+Lurbinectedin', 'description': 'Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles.\n\nMaintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle.', 'interventionNames': ['Drug: Atezolizumab', 'Drug: Lurbinectedin', 'Drug: Carboplatin', 'Drug: Etoposide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: Atezolizumab', 'description': 'Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles.\n\nMaintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle.', 'interventionNames': ['Drug: Atezolizumab', 'Drug: Carboplatin', 'Drug: Etoposide']}], 'interventions': [{'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['Tecentriq, RO5541267'], 'description': 'Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.', 'armGroupLabels': ['Arm A: Atezolizumab+Lurbinectedin', 'Arm B: Atezolizumab']}, {'name': 'Lurbinectedin', 'type': 'DRUG', 'otherNames': ['PM01183/JZP712'], 'description': 'Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.', 'armGroupLabels': ['Arm A: Atezolizumab+Lurbinectedin']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.', 'armGroupLabels': ['Arm A: Atezolizumab+Lurbinectedin', 'Arm B: Atezolizumab']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.', 'armGroupLabels': ['Arm A: Atezolizumab+Lurbinectedin', 'Arm B: Atezolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Cancer Care', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'New England Cancer Specialists', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cancer & Hematology Centers of Western Michigan', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Research - St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11590', 'city': 'Westbury', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Alliance', 'geoPoint': {'lat': 40.75566, 'lon': -73.58763}}, {'zip': '43219', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Mark H. Zangmeister Ctr', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Hollings Cancer Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Greco-Hainesworth Centers for Research', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'West Clinic', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute / Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '1070', 'city': 'Anderlecht', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Zkh (Campus Virga Jesse)', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2800', 'city': 'Mechelen', 'country': 'Belgium', 'facility': 'AZ St Maarten Campus Leopoldstr', 'geoPoint': {'lat': 51.02574, 'lon': 4.47762}}, {'zip': '5530', 'city': 'Mont-godinne', 'country': 'Belgium', 'facility': 'CHU UCL Mont-Godinne'}, {'zip': '9100', 'city': 'Sint-Niklaas', 'country': 'Belgium', 'facility': 'Vitaz', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}, {'zip': '99437', 'city': 'Bad Berka', 'country': 'Germany', 'facility': 'Zentralklinik Bad Berka GmbH', 'geoPoint': {'lat': 50.89982, 'lon': 11.28245}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Evang. Lungenklinik Berlin Klinik für Pneumologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '09116', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Klinikum Chemnitz gGmbH', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '45136', 'city': 'Essen', 'country': 'Germany', 'facility': 'KEM/Evang. Kliniken Essen Mitte gGmbH', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '49124', 'city': 'Georgsmarienhütte', 'country': 'Germany', 'facility': 'Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH', 'geoPoint': {'lat': 52.20296, 'lon': 8.0448}}, {'zip': '22927', 'city': 'Großhansdorf', 'country': 'Germany', 'facility': 'LungenClinic Großhansdorf GmbH', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'zip': '34376', 'city': 'Immenhausen', 'country': 'Germany', 'facility': 'Fachklinik für Lungenerkrankungen', 'geoPoint': {'lat': 51.42763, 'lon': 9.48017}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '82131', 'city': 'München-Gauting', 'country': 'Germany', 'facility': 'Asklepios Klinik Gauting'}, {'zip': '115 27', 'city': 'Athens', 'country': 'Greece', 'facility': 'Sotiria Thoracic Diseases Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11526', 'city': 'Athens', 'country': 'Greece', 'facility': 'Errikos Dynan Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '411 10', 'city': 'Larissa', 'country': 'Greece', 'facility': 'University Hospital of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '546 45', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Euromedical General Clinic of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '570 01', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Diavalkaniko Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '1121', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Orszagos Koranyi Pulmonologiai Intezet', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '7623', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Pécsi Tudományegyetem', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '5000', 'city': 'Szolnok', 'country': 'Hungary', 'facility': 'Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'zip': '2045', 'city': 'Törökbálint', 'country': 'Hungary', 'facility': 'Tudogyogyintezet Torokbalint', 'geoPoint': {'lat': 47.42931, 'lon': 18.91356}}, {'zip': '48121', 'city': 'Ravenna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'AUSL della Romagna', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '16125', 'city': 'Genoa', 'state': 'Liguria', 'country': 'Italy', 'facility': 'ASL 3 Genovese', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '20141', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Irccs Istituto Europeo di Oncologia (IEO)', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20162', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': "Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '60126', 'city': 'Torrette Di Ancona', 'state': 'The Marches', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Ospedali Riuniti'}, {'zip': '03100', 'city': 'Mexico City', 'state': 'Mexico CITY (federal District)', 'country': 'Mexico', 'facility': 'Health Pharma Professional Research', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '58260', 'city': 'Morelia', 'country': 'Mexico', 'facility': 'Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde', 'geoPoint': {'lat': 19.70078, 'lon': -101.18443}}, {'zip': '80-214', 'city': 'Gda?sk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne'}, {'zip': '31-202', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '10-357', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '05-400', 'city': 'Otwock', 'country': 'Poland', 'facility': 'Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy', 'geoPoint': {'lat': 52.10577, 'lon': 21.26129}}, {'zip': '60-569', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '28644', 'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'zip': '702-210', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Chilgok Kyungpook National University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '51353', 'city': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Samsung Changwon Hospital'}, {'zip': '52727', 'city': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Gyeongsang National University Hospital'}, {'zip': '13605', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'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': '44033', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hosiptal', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'LA Coruna', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario A Coruña (CHUAC)', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebron Institute of Oncology (VHIO), Barcelona", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', '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': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '824', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'E-DA Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '407', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '00704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '01120', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Adana Baskent University Hospital', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '06520', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Memorial Ankara Hastanesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06680', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Liv Hospital Ankara', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06800', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '16059', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Uludag Uni Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}, {'zip': '20070', 'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University School Of Medicine', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}, {'zip': '22030', 'city': 'Edirne', 'country': 'Turkey (Türkiye)', 'facility': 'Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}, {'zip': '34214', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Ba?c?lar Medipol Mega Üniversite Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34300', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Uni Cerrahpasa Medical Faculty Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34660', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Ac?badem Altunizade Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35101', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Medical Point Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '31380', 'city': 'İzmit', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University Faculty of Medicine', 'geoPoint': {'lat': 40.76499, 'lon': 29.92928}}, {'zip': '34722', 'city': 'Kadiköy', 'country': 'Turkey (Türkiye)', 'facility': 'Goztepe Prof.Dr. Suleyman Yalcin City Hospital', 'geoPoint': {'lat': 41.06639, 'lon': 41.01294}}, {'zip': '55200', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Medikal Park Samsun', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': '42080', 'city': 'Selçuklu', 'country': 'Turkey (Türkiye)', 'facility': 'TC Necmettin Erbakan University Meram Medical Faculty Hospital', 'geoPoint': {'lat': 37.8842, 'lon': 32.49222}}, {'zip': 'FY3 8NR', 'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool Victoria Hospital', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'M20 4BX', 'city': 'GB Manchester', 'country': 'United Kingdom', 'facility': 'Christie NHS Foundation Trust'}, {'zip': 'HU16 5JQ', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Castle Hill Hospital', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'St James University Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\\_sharing"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}