Study 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.

Additional Study Details

Phase
3
Product
  • naquotinib mesilate
  • Erlotinib
  • Gefitinib
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    530
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English
    Protocol
    Available Language(s): English
    Statistical Analysis Plan (SAP)
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants 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? Contact us by filling out your information to the right and we’ll respond to you.

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    • Algeria
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    • Armenia
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    • Austria
    • Belarus
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    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
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    • Jordan
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    • Montenegro
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      Locations

      Contact Us
      Contact Us
      Terminated
      Site DE49007
      Kassel, Hessen, Germany, 34125
      Terminated
      Site TW88604
      Tainan, Tainan, Taiwan, Province of China, 736
      Terminated
      Site RU70009
      Magnitogorsk, Chelyabinskaya oblast', Russian Federation, 455001
      Terminated
      Site KR82005
      Cheongiu, Chungcheongbugdo, Republic of Korea, 28644
      Terminated
      Site US10030
      Minneapolis, MN, United States, 55455
      Terminated
      Site TW88609
      Taipei, Taipei, Taiwan, Province of China, 11217
      Terminated
      Site TH66006
      Songkla, Songkla, Thailand, 90110
      Terminated
      Site FR33003
      Creteil, Ilej-de-France, France, 94010
      Withdrawn
      Site US10008
      Boynton Beach, FL, United States, 33426
      Terminated
      Site NL31006
      Alkmaar, Noord-Holland, Netherlands, 1815 JD
      Terminated
      Site US10025
      Fountain Valley, CA, United States, 90806
      Withdrawn
      Site JP81007
      Sendai, Miyagi, Japan, 980-0872
      Terminated
      Site AU61008
      East Melbourne, VIC, Australia, 3002
      Terminated
      Site GB44002
      Middlesex, Hertfordshire, United Kingdom, HA6 2RN
      Withdrawn
      Site US10058
      Scottsdale, AZ, United States, 85259
      Terminated
      Site JP81010
      Yokohama, Kanagawa, Japan, 236-0051
      Terminated
      Site KR82014
      Seoul, Seoul Teugbyeolsi, Republic of Korea, 130-701
      Withdrawn
      Site US10041
      Jackson, MS, United States, 39202
      Withdrawn
      Site CA15007
      Quebec City, QC, Canada, G1V 4G5
      Terminated
      Site KR82016
      Suwon-si, Gyeonggido [Kyonggi-do], Republic of Korea, 16427
      Terminated
      Site GB44001
      Liverpool, Wirral, United Kingdom, CH63 4JY
      Terminated
      Site US10009
      Nashville, TN, United States, 37203
      Terminated
      Site US10036
      La Jolla, CA, United States, 92093
      Terminated
      Site IT39011
      Aviano, Pordenone, Italy, 33081
      Withdrawn
      Site BE32004
      Ottignies, Brabant Wallon, Belgium, 1340
      Terminated
      Site JP81014
      Sapporo, Hokkaidô, Japan, 003-0804
      Terminated
      Site TH66011
      Chom Thong, Chiang Mai, Thailand, 50200
      Terminated
      Site NL31001
      Arnhem, Gelderland, Netherlands, 6815 AD
      Terminated
      Site HU36002
      Szekesfehervar, Fejér, Hungary, H 8000
      Terminated
      Site HU36007
      Budapest, Budapest, Hungary, 1121
      Terminated
      Site ES34002
      Valencia, Valencia, Spain, 46026
      Terminated
      Site IT39003
      Bergamo, Bergamo, Italy, 24127
      Terminated
      Site UA38001
      Dnipropetrovsk, Dnipropetrovs'ka Oblast', Ukraine, 49102
      Terminated
      Site TH66002
      Chiang Rai, Thailand, 57000
      Withdrawn
      Site RO40005
      Iasi, Iasi, Romania, 700483
      Terminated
      Site RU70001
      Saint Petersburg, Saint Petersburg, Russian Federation, 197022
      Terminated
      Site US10011
      Lacey, WA, United States, 98503
      Terminated
      Site KR82004
      Suwon-si, Gyeonggi-do, Republic of Korea, 16499
      Terminated
      Site JP81013
      Hiroshima, Hirosima [Hiroshima], Japan, 730-8518
      Terminated
      Site ES34005
      Sevilla, Sevilla, Spain, 41009
      Terminated
      Site ES34015
      Valencia, Valencia, Spain, 46010
      Terminated
      Site JP81020
      Osakasayama-shi, Osaka, Japan, 569-8511
      Terminated
      Site PT35102
      Lisboa, Lisboa, Portugal, 1400-038
      Terminated
      Site CA15006
      Toronto, ON, Canada, M5G 2C4
      Withdrawn
      Site US10054
      Fort Worth, TX, United States, 76104
      Withdrawn
      Site FR33001
      Clermont Ferrand, Auvergne, France, 63003
      Terminated
      Site RU70016
      Nalchik, Kabardino-Balkarskaya Respublika, Russian Federation, 360000
      Terminated
      Site JP81025
      Yokohama, Kanagawa, Japan, 241-8515
      Terminated
      Site BE32002
      Gent, West-Vlaanderen, Belgium, 9000
      Terminated
      Site KR82002
      Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Republic of Korea, 028-481
      Terminated
      Site PT35103
      Coimbra, Coimbra, Portugal, 3041-801
      Terminated
      Site US10042
      Baton Rouge, LA, United States, 70809
      Withdrawn
      Site FR33005
      Rouen, Haute-Normandie, France, 76000
      Terminated
      Site FR33007
      Pierre Benite, Rhône, France, 69310
      Terminated
      Site RO40004
      Floresti, Cluj, Romania, 407280
      Withdrawn
      Site RU70004
      Moscow, Moskovskaya oblast', Russian Federation, 143423
      Terminated
      Site KR82009
      Jinju-si, Gyeongsangnamdo, Republic of Korea, 660-702
      Terminated
      Site US10051
      Loma Linda, CA, United States, 92350
      Terminated
      Site JP81012
      Sendai, Miyagi, Japan, 980-0873
      Terminated
      Site FR33006
      Grenoble, Isère, France, 38043
      Terminated
      Site JP81018
      Matsuyama, Ehime, Japan, 791-0280
      Terminated
      Site JP81006
      Okayama, Okayama, Japan, 700-8558
      Withdrawn
      Site AU61009
      Coffs Harbour, NSW, Australia, 2450
      Withdrawn
      Site RU70011
      Kazan, Tatarstan, Respublika, Russian Federation, 420029
      Terminated
      Site JP81008
      Kurume, Hukuoka, Japan, 830-0011
      Terminated
      Site ES34017
      Valencia, Valencia, Spain, 46014
      Withdrawn
      Site BR55013
      Sao Paulo, Sao Paulo, Brazil, 04039-001
      Terminated
      Site AU61005
      Adelaide, SA, Australia, 5000
      Terminated
      Site RU70008
      Pyatigorsk, Stavropol'skiy kray, Russian Federation, 357502
      Terminated
      Site KR82013
      Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Republic of Korea, 135-720
      Terminated
      Site KR82015
      Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Republic of Korea, 5368
      Terminated
      Site IT39012
      Piacenza, Piacenza, Italy, 29100
      Terminated
      Site ES34003
      Barcelona, Catalunya, Spain, 08036
      Terminated
      Site CA15002
      Montreal, QC, Canada, H49 1C5
      Withdrawn
      Site HU36005
      Miskolc, Borsod-Abaúj-Zemplén, Hungary, 3529
      Terminated
      Site TW88603
      Taichung, Taichung, Taiwan, Province of China, 40705
      Terminated
      Site AU61007
      Woolloongabba, QLD, Australia, 4102
      Withdrawn
      Site CA15003
      Sault Ste Marie, ON, Canada, P6B 0A8
      Terminated
      Site HU36001
      Budapest, Budapest, Hungary, 1125
      Terminated
      Site RU70012
      Arkhangelsk, Arkhangel'skaya oblast', Russian Federation, 163045
      Terminated
      Site JP81016
      Kurashiki, Okayama, Japan, 710-8602
      Terminated
      Site US10050
      Atlanta, GA, United States, 30342
      Terminated
      Site HU36003
      Tatabanya, Tatabánya, Hungary, H-2800
      Terminated
      Site ES34016
      Madrid, Madrid, Spain, 28050
      Terminated
      Site JP81019
      Sunto-gun, Shizuoka, Japan, 411-8777
      Terminated
      Site JP81001
      Sunto-gun, Sizuoka [Shizuoka], Japan, 411-8777
      Terminated
      Site TH66004
      Khon Kaen, Khon Kaen, Thailand, 40002
      Terminated
      Site HU36004
      Farkasgyepu, Veszprém, Hungary, 8582
      Terminated
      Site RO40007
      Ploiesti, Prahova, Romania, 100010
      Withdrawn
      Site BE32005
      Namur, Namur, Belgium, 5000
      Terminated
      Site DE49006
      Wurzburg, Bayern, Germany, 97080
      Terminated
      Site JP81017
      Osakasayama-shi, Hukuoka [Fukuoka], Japan, 589-8511
      Terminated
      Site IT39002
      Cremona, Cremona, Italy, 26100
      Terminated
      Site PT35104
      Lisbon, Lisboa, Portugal, 1099-023
      Terminated
      Site US10033
      Los Angeles, CA, United States, 90033
      Terminated
      Site DE49005
      Karlsruhe, Baden-Württemberg, Germany, 76137
      Terminated
      Site JP81004
      Tokyo, Tôkyô [Tokyo], Japan, 135-8550
      Terminated
      Site TW88605
      Taichung City, Taichung, Taiwan, Province of China, 40447
      Terminated
      Site ES34004
      Ourense, Ourense, Spain, 32004
      Terminated
      Site KR82008
      Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Republic of Korea, 152-703
      Terminated
      Site IT39013
      Lucca, Lucca, Italy, 55100
      Terminated
      Site UA38004
      Lviv, L'vivs'ka Oblast', Ukraine, 79031
      Withdrawn
      Site US10019
      Corvallis, OR, United States, 97330
      Terminated
      Site UA38003
      Uzhgorod, Zakarpats'ka Oblast', Ukraine, 88014
      Terminated
      Site TW88606
      Kaohsiung, Kaohsiung, Taiwan, Province of China, 83301
      Withdrawn
      Site HU36008
      Budapest, Budapest, Hungary, 1121
      Terminated
      Site KR82010
      Busan Gwang'yeogsi, Busan Gwang'yeogsi, Republic of Korea, 48108
      Terminated
      Site ES34008
      San Sebastian, Guipuzcoa, Guipúzcoa, Spain, 20014
      Terminated
      Site MY60002
      Georgetown, Pulau Pinang, Malaysia, 10450
      Terminated
      Site MY60004
      Kuching, Sarawak, Malaysia, 93586
      Terminated
      Site JP81022
      Niigata, Niigata, Japan, 951-8122
      Terminated
      Site FR33009
      Saint Priest en Jarez, Loire, France, 42270
      Terminated
      Site RO40010
      Craiova, Dolj, Romania, 200385
      Terminated
      Site US10023
      Nashville, TN, United States, 37232
      Terminated
      Site UA38007
      Lutsk, Volyns'ka Oblast', Ukraine, 43018
      Withdrawn
      Site US10020
      Baltimore, MD, United States, 21287
      Terminated
      Site RO40008
      Timisoara, Timis, Romania, 300210
      Terminated
      Site PE51004
      San Isidro, Lima, Peru, 1501
      Withdrawn
      Site US10053
      Fullerton, CA, United States, 92835
      Withdrawn
      Site ES34007
      Pamplona, Navarra, Navarra, Spain, 31008
      Terminated
      Site UA38008
      Ivano-Frankivsk, Ivano-Frankivs'ka Oblast', Ukraine, 76000
      Terminated
      Site DE49008
      Freiburg, Baden-Württemberg, Germany, 79106
      Terminated
      Site RO40001
      Craiova, Dolj, Romania, 200347
      Terminated
      Site RU70017
      Ufa, Bashkortostan, Russian Federation, 450054
      Terminated
      Site KR82003
      Jeonju, Jeonrabugdo[Chollabuk-do], Republic of Korea, 54907
      Terminated
      Site US10045
      Albuquerque, NM, United States, 87106
      Terminated
      Site TW88611
      Taipei, Taipei, Taiwan, Province of China, 11490
      Terminated
      Site AU61003
      Randwick, NSW, Australia, 2031
      Terminated
      Site KR82006
      Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Republic of Korea, 156-707
      Terminated
      Site TW88601
      Tainan, Tainan, Taiwan, Province of China, 70403
      Terminated
      Site ES34006
      Madrid, Madrid, Spain, 28046
      Withdrawn
      Site US10016
      La Jolla, CA, United States, 92037
      Terminated
      Site MY60001
      Kuantan Pahang, Pahang, Malaysia, 25100
      Terminated
      Site UA38005
      Kryvyi Rih, Dnipropetrovs'ka Oblast', Ukraine, 50048
      Terminated
      Site US10046
      Milwaukee, WI, United States, 53226
      Terminated
      Site KR82017
      Bundang, Gyeonggido, Republic of Korea, 13620
      Terminated
      Site IT39014
      Milano, Milano, Italy, 20142
      Terminated
      Site CL56001
      Santiago, Región Metropolitana de Santia, Chile, 8380455
      Terminated
      Site ES34010
      Malaga, Málaga, Spain, 29010
      Terminated
      Site US10021
      Bethlehem, PA, United States, 18015
      Terminated
      Site JP81002
      Osaka-sayama, Ôsaka [Osaka], Japan, 589-8511
      Terminated
      Site JP81024
      Kobe, Hyogo, Japan, 650-0047
      Terminated
      Site KR82011
      Ulsan, Ulsan Gwang'yeogsi, Republic of Korea, 682-714
      Terminated
      Site FR33004
      Tours, Indre-et-Loire, France, 37044
      Withdrawn
      Site US10055
      Bakersfield, CA, United States, 93309
      Terminated
      Site JP81023
      Wakayama, Wakayama, Japan, 641-8510
      Terminated
      Site DE49003
      Gauting, Bayern, Germany, 82131
      Terminated
      Site UA38009
      Uzhgorod, Zakarpats'ka Oblast', Ukraine, 88000
      Withdrawn
      Site US10026
      Germantown, TN, United States, 38138
      Terminated
      Site IT39009
      Rozzano, Lombardia, Italy, 20089
      Terminated
      Site RO40006
      Sibiu, Sibiu, Romania, 550245
      Terminated
      Site TW88607
      Taoyuan Hsien, Taoyuan, Taiwan, Province of China, 33305
      Terminated
      Site KR82001
      Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Republic of Korea, 05505
      Terminated
      Site IT39015
      Brescia, Brescia, Italy, 25123
      Terminated
      Site US10034
      Boston, MA, United States, 02111
      Withdrawn
      Site AU61010
      Kogarah, NSW, Australia, 2217
      Terminated
      Site TH66001
      Bangkok, Krung Thep Maha Nakhon [Bangkok], Thailand, 10330
      Terminated
      Site JP81015
      Kanazawa, Isikawa [Ishikawa], Japan, 920-8530
      Withdrawn
      Site CA15010
      Montreal, QC, Canada, H4A 3J1
      Terminated
      Site IT39004
      Monza, Lombardia, Italy, 20052
      Terminated
      Site US10029
      Beverly Hills, CA, United States, 90211
      Terminated
      Site FR33012
      Bayonne, Pyrénées-Atlantiques, France, 64100
      Terminated
      Site US10052
      Redondo Beach, CA, United States, 90277
      Terminated
      Site SG65002
      Singapore, Central Singapore, Singapore, 308433
      Withdrawn
      Site US10035
      Fort Lauderdale, FL, United States, 33308
      Terminated
      Site FR33010
      Pessac, Gironde, France, 33604
      Terminated
      Site TH66012
      Bangkok, Krung Thep Maha Nakhon [Bangkok], Thailand, 10400
      Terminated
      Site US10048
      St. Petersburg, FL, United States, 33705
      Terminated
      Site US10012
      Mt Kisco, NY, United States, 10549
      Withdrawn
      Site US10007
      Jacksonville, FL, United States, 32204
      Terminated
      Site JP81005
      Miyakojima-ku, Osaka, Japan, 534-0021
      Terminated
      Site PT35101
      Amadora, Lisboa, Portugal, 2720-276
      Withdrawn
      Site RO40013
      Otopeni, Ilfov, Romania, 075100
      Terminated
      Site US10031
      Oxnard, CA, United States, 93030
      Terminated
      Site US10037
      Scarborough, ME, United States, 04074
      Terminated
      Site UA38006
      Chernivtsi, Chernivets'ka Oblast', Ukraine, 58013
      Terminated
      Site CL56002
      Vina del Mar, Valparaíso, Chile, 2520612
      Terminated
      Site US10013
      Aventura, FL, United States, 33180
      Terminated
      Site SG65001
      Singapore, Central Singapore, Singapore, 188770
      Terminated
      Site US10027
      Rochester, MN, United States, 55905
      Withdrawn
      Site NL31002
      Harderwijk, Gelderland, Netherlands, 3844 GD
      Terminated
      Site CL56007
      Vina del Mar, Valparaíso, Chile, 2540364
      Terminated
      Site RO40012
      Bucuresti, Bucuresti, Romania, 031422
      Terminated
      Site HU36006
      Szombathely, Vas, Hungary, H 9700
      Terminated
      Site US10047
      Glenwood Springs, CO, United States, 81601
      Terminated
      Site PE51001
      Cercado de Lima, Arequipa, Peru, 04001
      Terminated
      Site JP81021
      Hirakata, Ôsaka [Osaka], Japan, 573-1191
      Terminated
      Site AU61002
      Fitzroy, VIC, Australia, 3065
      Withdrawn
      Site FR33008
      Strasbourg, Alsace, France, 67091
      Terminated
      Site KR82007
      Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Republic of Korea, 139-706
      Withdrawn
      Site US10061
      Lansing, MI, United States, 48909
      Terminated
      Site US10003
      Santa Monica, CA, United States, 90404
      Terminated
      Site DE49004
      Köln, Nordrhein-Westfalen, Germany, 51109
      Terminated
      Site IT39008
      Roma, Roma, Italy, 00128
      Terminated
      Site PE51008
      Miraflores, Lima, Peru, L18
      Terminated
      Site TW88608
      Taipei, Taipei, Taiwan, Province of China, 100
      Terminated
      Site AU61004
      Footscray, VIC, Australia, 3011
      Withdrawn
      Site IT39006
      Pisa, Pisa, Italy, 56126
      Terminated
      Site US10018
      Whittier, CA, United States, 90603
      Terminated
      Site GB44003
      Sheffield, Sheffield, United Kingdom, S10 2SJ
      Terminated
      Site FR33011
      Suresnes, Hauts-de-Seine, France, 92150

      Frequently Asked Questions

      Are clinical trials only for people with advanced cancer?

      While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

      Will I have to stop my current treatment to participate in a clinical trial?

      Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

      Should I be worried about getting a placebo?

      In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

      Do I need a referral from my doctor to take part in a study?

      Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

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