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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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