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
N/A
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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  • China
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  • Egypt
  • Estonia
  • Finland
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  • France
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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?

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    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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