Spots Global Cancer Trial Database for A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations
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Trial Identification
Brief Title: A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations
Official Title: An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations
Study ID: NCT02588261
Conditions
Study Description
Brief Summary: The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. This study also assessed Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site US10029, Beverly Hills, California, United States
Site US10025, Fountain Valley, California, United States
Site US10036, La Jolla, California, United States
Site US10051, Loma Linda, California, United States
Site US10033, Los Angeles, California, United States
Site US10031, Oxnard, California, United States
Site US10052, Redondo Beach, California, United States
Site US10003, Santa Monica, California, United States
Site US10018, Whittier, California, United States
Site US10047, Glenwood Springs, Colorado, United States
Site US10013, Aventura, Florida, United States
Site US10048, Saint Petersburg, Florida, United States
Site US10050, Atlanta, Georgia, United States
Site US10042, Baton Rouge, Louisiana, United States
Site US10037, Scarborough, Maine, United States
Site US10034, Boston, Massachusetts, United States
Site US10030, Minneapolis, Minnesota, United States
Site US10027, Rochester, Minnesota, United States
Site US10045, Albuquerque, New Mexico, United States
Site US10012, Mount Kisco, New York, United States
Site US10021, Bethlehem, Pennsylvania, United States
Site US10009, Nashville, Tennessee, United States
Site US10023, Nashville, Tennessee, United States
Site US10011, Lacey, Washington, United States
Site US10046, Milwaukee, Wisconsin, United States
Site AU61003, Randwick, New South Wales, Australia
Site AU61007, Woolloongabba, Queensland, Australia
Site AU61005, Adelaide, South Australia, Australia
Site AU61008, East Melbourne, Victoria, Australia
Site AU61002, Fitzroy, Victoria, Australia
Site AU61004, Footscray, Victoria, Australia
Site BE32002, Gent, West-Vlaanderen, Belgium
Site CA15006, Toronto, Ontario, Canada
Site CA15002, Montreal, Quebec, Canada
Site CL56001, Santiago, Región Metropolitana De Santia, Chile
Site CL56002, Vina del Mar, Valparaíso, Chile
Site CL56007, Vina del Mar, Valparaíso, Chile
Site FR33010, Pessac, Gironde, France
Site FR33011, Suresnes, Hauts-de-Seine, France
Site FR33003, Creteil, Ilej-de-France, France
Site FR33004, Tours, Indre-et-Loire, France
Site FR33006, Grenoble, Isère, France
Site FR33009, Saint Priest en Jarez, Loire, France
Site FR33012, Bayonne, Pyrénées-Atlantiques, France
Site FR33007, Pierre Benite, Rhône, France
Site DE49008, Freiburg, Baden-Württemberg, Germany
Site DE49005, Karlsruhe, Baden-Württemberg, Germany
Site DE49003, Gauting, Bayern, Germany
Site DE49006, Wurzburg, Bayern, Germany
Site DE49007, Kassel, Hessen, Germany
Site DE49004, Köln, Nordrhein-Westfalen, Germany
Site HU36002, Szekesfehervar, Fejér, Hungary
Site HU36003, Tatabanya, Tatabánya, Hungary
Site HU36006, Szombathely, Vas, Hungary
Site HU36004, Farkasgyepu, Veszprém, Hungary
Site HU36007, Budapest, , Hungary
Site HU36001, Budapest, , Hungary
Site IT39004, Monza, Lombardia, Italy
Site IT39009, Rozzano, Lombardia, Italy
Site IT39011, Aviano, Pordenone, Italy
Site IT39003, Bergamo, , Italy
Site IT39015, Brescia, , Italy
Site IT39002, Cremona, , Italy
Site IT39013, Lucca, , Italy
Site IT39014, Milano, , Italy
Site IT39012, Piacenza, , Italy
Site IT39008, Roma, , Italy
Site JP81018, Matsuyama, Ehime, Japan
Site JP81013, Hiroshima, Hirosima [Hiroshima], Japan
Site JP81014, Sapporo, Hokkaidô, Japan
Site JP81017, Osakasayama-shi, Hukuoka [Fukuoka], Japan
Site JP81008, Kurume, Hukuoka, Japan
Site JP81024, Kobe, Hyogo, Japan
Site JP81015, Kanazawa, Isikawa [Ishikawa], Japan
Site JP81010, Yokohama, Kanagawa, Japan
Site JP81025, Yokohama, Kanagawa, Japan
Site JP81012, Sendai, Miyagi, Japan
Site JP81016, Kurashiki, Okayama, Japan
Site JP81005, Miyakojima-ku, Osaka, Japan
Site JP81020, Osakasayama-shi, Osaka, Japan
Site JP81019, Sunto-gun, Shizuoka, Japan
Site JP81001, Sunto-gun, Sizuoka [Shizuoka], Japan
Site JP81004, Tokyo, Tôkyô [Tokyo], Japan
Site JP81022, Niigata, , Japan
Site JP81006, Okayama, , Japan
Site JP81023, Wakayama, , Japan
Site JP81021, Hirakata, Ôsaka [Osaka], Japan
Site JP81002, Osaka-sayama, Ôsaka [Osaka], Japan
Site KR82005, Cheongiu, Chungcheongbugdo, Korea, Republic of
Site KR82004, Suwon-si, Gyeonggi-do, Korea, Republic of
Site KR82016, Suwon-si, Gyeonggido [Kyonggi-do], Korea, Republic of
Site KR82017, Bundang, Gyeonggido, Korea, Republic of
Site KR82009, Jinju-si, Gyeongsangnamdo, Korea, Republic of
Site KR82003, Jeonju, Jeonrabugdo[Chollabuk-do], Korea, Republic of
Site KR82002, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of
Site KR82001, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of
Site KR82013, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of
Site KR82007, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of
Site KR82008, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of
Site KR82006, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of
Site KR82015, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of
Site KR82014, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Site KR82011, Ulsan, Ulsan Gwang'yeogsi, Korea, Republic of
Site KR82010, Busan Gwang'yeogsi, , Korea, Republic of
Site MY60001, Kuantan Pahang, Pahang, Malaysia
Site MY60002, Georgetown, Pulau Pinang, Malaysia
Site MY60004, Kuching, Sarawak, Malaysia
Site NL31001, Arnhem, Gelderland, Netherlands
Site NL31006, Alkmaar, Noord-Holland, Netherlands
Site PE51001, Cercado De Lima, Arequipa, Peru
Site PE51008, Miraflores, Lima, Peru
Site PE51004, San Isidro, Lima, Peru
Site PT35101, Amadora, Lisboa, Portugal
Site PT35104, Lisbon, Lisboa, Portugal
Site PT35103, Coimbra, , Portugal
Site PT35102, Lisboa, , Portugal
Site RO40004, Floresti, Cluj, Romania
Site RO40001, Craiova, Dolj, Romania
Site RO40010, Craiova, Dolj, Romania
Site RO40007, Ploiesti, Prahova, Romania
Site RO40008, Timisoara, Timis, Romania
Site RO40012, Bucuresti, , Romania
Site RO40006, Sibiu, , Romania
Site RU70012, Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation
Site RU70017, Ufa, Bashkortostan, Russian Federation
Site RU70009, Magnitogorsk, Chelyabinskaya Oblast', Russian Federation
Site RU70016, Nalchik, Kabardino-Balkarskaya Respublika, Russian Federation
Site RU70008, Pyatigorsk, Stavropol'skiy Kray, Russian Federation
Site RU70001, Saint Petersburg, , Russian Federation
Site SG65001, Singapore, Central Singapore, Singapore
Site SG65002, Singapore, Central Singapore, Singapore
Site ES34003, Barcelona, Catalunya, Spain
Site ES34008, San Sebastian, Guipuzcoa, Guipúzcoa, Spain
Site ES34010, Malaga, Málaga, Spain
Site ES34006, Madrid, , Spain
Site ES34016, Madrid, , Spain
Site ES34004, Ourense, , Spain
Site ES34005, Sevilla, , Spain
Site ES34015, Valencia, , Spain
Site ES34017, Valencia, , Spain
Site ES34002, Valencia, , Spain
Site TW88605, Taichung City, Taichung, Taiwan
Site TW88607, Taoyuan Hsien, Taoyuan, Taiwan
Site TW88606, Kaohsiung, , Taiwan
Site TW88603, Taichung, , Taiwan
Site TW88601, Tainan, , Taiwan
Site TW88604, Tainan, , Taiwan
Site TW88608, Taipei, , Taiwan
Site TW88609, Taipei, , Taiwan
Site TW88611, Taipei, , Taiwan
Site TH66011, Chom Thong, Chiang Mai, Thailand
Site TH66001, Bangkok, Krung Thep Maha Nakhon [Bangkok], Thailand
Site TH66012, Bangkok, Krung Thep Maha Nakhon [Bangkok], Thailand
Site TH66002, Chiang Rai, , Thailand
Site TH66004, Khon Kaen, , Thailand
Site TH66006, Songkla, , Thailand
Site UA38006, Chernivtsi, Chernivets'ka Oblast', Ukraine
Site UA38001, Dnipropetrovsk, Dnipropetrovs'ka Oblast', Ukraine
Site UA38005, Kryvyi Rih, Dnipropetrovs'ka Oblast', Ukraine
Site UA38008, Ivano-Frankivsk, Ivano-Frankivs'ka Oblast', Ukraine
Site UA38004, Lviv, L'vivs'ka Oblast', Ukraine
Site UA38007, Lutsk, Volyns'ka Oblast', Ukraine
Site UA38009, Uzhgorod, Zakarpats'ka Oblast', Ukraine
Site UA38003, Uzhgorod, Zakarpats'ka Oblast', Ukraine
Site GB44002, Middlesex, Hertfordshire, United Kingdom
Site GB44001, Liverpool, Wirral, United Kingdom
Site GB44003, Sheffield, , United Kingdom
Contact Details
Name: Medical Monitor
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR
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