Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT03006705
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2016-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Adjuvant ONO-4538 With Resected Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2016-12-27', 'studyFirstSubmitQcDate': '2016-12-27', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-free survival (RFS)', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '5 years'}, {'measure': '3-year OS rate', 'timeFrame': '3 years'}, {'measure': '5-year OS rate', 'timeFrame': '5 years'}, {'measure': '3-year RFS rate', 'timeFrame': '3 years'}, {'measure': '5-year RFS rate', 'timeFrame': '5 years'}, {'measure': 'Safety will be analyzed through the incidence of adverse events, serious adverse events', 'timeFrame': 'Up to 28 days from last dose'}, {'measure': 'Safety will be analyzed through the incidence of laboratory abnormalities', 'timeFrame': 'Up to 28 days from last dose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '38906161', 'type': 'DERIVED', 'citation': 'Kang YK, Terashima M, Kim YW, Boku N, Chung HC, Chen JS, Ji J, Yeh TS, Chen LT, Ryu MH, Kim JG, Omori T, Rha SY, Kim TY, Ryu KW, Sakuramoto S, Nishida Y, Fukushima N, Yamada T, Bai LY, Hirashima Y, Hagihara S, Nakada T, Sasako M. Adjuvant nivolumab plus chemotherapy versus placebo plus chemotherapy for stage III gastric or gastro-oesophageal junction cancer after gastrectomy with D2 or more extensive lymph-node dissection (ATTRACTION-5): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Aug;9(8):705-717. doi: 10.1016/S2468-1253(24)00156-0. Epub 2024 Jun 18.'}, {'pmid': '35623069', 'type': 'DERIVED', 'citation': 'Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed adenocarcinoma of the stomach\n* Patients without a remnant cancer (R0) who have undergone gastrectomy\n* Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1\n\nExclusion Criteria:\n\n* Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer\n* Multiple primary cancers\n* A current or past history of severe hypersensitivity to any other antibody products\n* Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease'}, 'identificationModule': {'nctId': 'NCT03006705', 'briefTitle': 'Study of Adjuvant ONO-4538 With Resected Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'ONO-4538-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nivolumab group', 'description': 'Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).\n\nChemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator.\n\nS-1 therapy(maximum 1 year):\n\nTegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off\n\nCapeOX Therapy(maximum 6 months):\n\nOxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.\n\nCapecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.', 'interventionNames': ['Drug: Nivolumab', 'Drug: Tegafur-gimeracil-oteracil potassium', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo: Placebo solution intravenously for 30 min in every 3 weeks (maximum 1 year).\n\nChemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator.\n\nS-1 therapy(maximum 1 year):\n\nTegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off\n\nCapeOX Therapy(maximum 6 months):\n\nOxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.\n\nCapecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.', 'interventionNames': ['Drug: Tegafur-gimeracil-oteracil potassium', 'Drug: Oxaliplatin', 'Drug: Capecitabine', 'Drug: Placebo']}], 'interventions': [{'name': 'Nivolumab', 'type': 'DRUG', 'otherNames': ['BMS-936558', 'ONO-4538', 'MDX-1106'], 'description': 'Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).', 'armGroupLabels': ['Nivolumab group']}, {'name': 'Tegafur-gimeracil-oteracil potassium', 'type': 'DRUG', 'description': 'Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off', 'armGroupLabels': ['Nivolumab group', 'Placebo group']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.', 'armGroupLabels': ['Nivolumab group', 'Placebo group']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.', 'armGroupLabels': ['Nivolumab group', 'Placebo group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anhui Province', 'country': 'China', 'facility': 'Anhui Province Clinical Site'}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Clinical Site1', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Clinical Site2', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Cuangdong Province', 'country': 'China', 'facility': 'Cuangdong Province Clinical Site'}, {'city': 'Guangdong Province', 'country': 'China', 'facility': 'Guangdong Province Clinical Site1'}, {'city': 'Guangdong Province', 'country': 'China', 'facility': 'Guangdong Province Clinical Site2'}, {'city': 'Henan Province', 'country': 'China', 'facility': 'Henan Province Clinical Site1'}, {'city': 'Henan Province', 'country': 'China', 'facility': 'Henan Province Clinical Site2'}, {'city': 'Jiangsu Province', 'country': 'China', 'facility': 'Jiangsu Province Clinical Site1'}, {'city': 'Jiangsu Province', 'country': 'China', 'facility': 'Jiangsu Province Clinical Site3'}, {'city': 'Jiangsu Province', 'country': 'China', 'facility': 'Jiangsu Province Clinical Site4'}, {'city': 'Jiangsu Province', 'country': 'China', 'facility': 'Jiangsu Province Clinical Site5'}, {'city': 'Jiangsu Province', 'country': 'China', 'facility': 'Jiangsu Province Clinical Site6'}, {'city': 'Jiangxi Province', 'country': 'China', 'facility': 'Jiangxi Province Clinical Site2'}, {'city': 'Jilin Province', 'country': 'China', 'facility': 'Jilin Province Clinical Site'}, {'city': 'Liaoning Province', 'country': 'China', 'facility': 'Liaoning Province Clinical Site'}, {'city': 'Shanxi Province', 'country': 'China', 'facility': 'Shanxi Province Clinical Site'}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Clinical Site1', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Clinical Site2', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Zhejiang Province', 'country': 'China', 'facility': 'Zhejiang Province Clinical Site'}, {'city': 'Zhengjiang Province', 'country': 'China', 'facility': 'Zhengjiang Province Clinical Site'}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Clinical Site1', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Clinical Site2', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Kamogawa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Chiba Clinical Site', 'geoPoint': {'lat': 35.0969, 'lon': 140.1003}}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Ehime Clinical Site', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Ehime Clinicla Site', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Ōgaki', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Gifu Clinical Site', 'geoPoint': {'lat': 35.35, 'lon': 136.61667}}, {'city': 'Ōta', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Gunma Clinical Site', 'geoPoint': {'lat': 36.3, 'lon': 139.36667}}, {'city': 'Takasaki', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Gunma Clinical Site', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'city': 'Fukuyama', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima Clinical Site', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'city': 'Hakodate', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Clinical Site 3', 'geoPoint': {'lat': 41.77583, 'lon': 140.73667}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Clinical Site 1', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Clinical Site2', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Akashi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Hyogo Clinical Site', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'city': 'Amagasaki', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Hyogo Clinical Site', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'city': 'Nishinomiya', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Hyogo Clinical Site', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Ishikawa Clinical Site', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Iwate Clinical Site', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kanagawa Clinical Site', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kanagawa Clinical Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Ōsaki', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Miyagi Clinical Site', 'geoPoint': {'lat': 38.58866, 'lon': 140.973}}, {'city': 'Saku', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Nagano Clinical Site', 'geoPoint': {'lat': 36.21667, 'lon': 138.48333}}, {'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Okayama Clinical Site', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'city': 'Hirakata', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'city': 'Ōsaka-sayama', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site', 'geoPoint': {'lat': 34.49524, 'lon': 135.55069}}, {'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Takatsuki', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'city': 'Toyonaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}, {'city': 'Hidaka', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Clinical Site', 'geoPoint': {'lat': 35.91664, 'lon': 139.36233}}, {'city': 'Kitaadachi-gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Clinical Site'}, {'city': 'Sunto-gun', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka Clinical Site'}, {'city': 'Shimotsuke', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'Tochigi Clinical Site', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Clinical Site'}, {'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Clinical Site'}, {'city': 'Koto-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Clinical Site'}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Clinical Site'}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Chiba Clinical Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka Clinical Site 1', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka Clinical Site 2', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Gifu', 'country': 'Japan', 'facility': 'Gifu Clinical Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima Clinical Site1', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima Clinical Site2', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima Clinical Site3', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kochi', 'country': 'Japan', 'facility': 'Kochi Clinical Site', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto Clinical Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto Clinical Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Niigata', 'country': 'Japan', 'facility': 'Niigata Clinical Site', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site1', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site2', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site3', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Clinical Site4', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka Clinical Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Toyama', 'country': 'Japan', 'facility': 'Toyama Clinical Site', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Wakayama', 'country': 'Japan', 'facility': 'Wakayama Clinical Site', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'city': 'Yamagata', 'country': 'Japan', 'facility': 'Yamagata Clinical Site', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Busan Clinical Site1', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Busan Clinical Site2', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Busan Clinical Site3', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Clinical Site1', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Clinical Site2', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Clinical Site3', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Daejeon Clinical Site 1', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Daejeon Clinical Site 2', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Gwangju Clinical Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Gyeonggi-do Clinical Site1', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Gyeonggi-do Clinical Site2', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Gyeonggi-do Clinical Site3', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Gyeonggi-do Clinical Site4', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Gyeonggi-do Clinical Site5', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Jeollabuk-do Clinical Site'}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Clinical Site 8', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Clinical Site 9', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Clinical Site1', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Clinical Site2', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Clinical Site3', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Clinical Site4', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Clinical Site5', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Clinical Site6', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Clinical Site7', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Clinical Site2', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Clinical Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'New Taipei Clinical Site', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Clinical Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Tainan Clinical Site2', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Tainan Clinical Site', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Clinical Site1', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Clinical Site2', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Project Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}