- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02511106
AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy. (ADAURA)
A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bedford Park, Australia, 5042
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Camperdown, Australia, 2050
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Darlinghurst, Australia, 2010
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Heidelberg, Australia, 3084
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Kogarah, Australia, 2217
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Kurralta Park, Australia, 5037
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Woolloongabba, Australia, 4102
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Brussel, Belgium, 1200
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Brussels, Belgium, 1090
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Gent, Belgium, 9000
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Kortrijk, Belgium, 8500
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Barretos, Brazil, 14784-400
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Cachoeira De Itapemirim, Brazil, 29308-055
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Curitiba, Brazil, 81520-060
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Florianópolis, Brazil, 88034-000
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Fortaleza, Brazil, 60810-180
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Lajeado, Brazil, 95900000
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Porto Alegre, Brazil, 90619-900
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Rio de Janeiro, Brazil, 22793-080
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Salvador, Brazil, 40170-110
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São José do Rio Preto, Brazil, 15025-100
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São Paulo, Brazil, 01321-001
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
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Beijing, China, 100142
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Beijing, China, 100730
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Beijing, China, 100029
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Beijing, China, 100210
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Changchun, China, 130012
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Changchun, China, 130021
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Dalian, China, 116027
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Guangzhou, China, 510120
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Guangzhou, China, 510180
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Guangzhou, China, 510060
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Hangzhou, China, 310022
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Hangzhou, China, 310003
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Hangzhou, China, 310009
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Kunming, China, 650118
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Nanjing, China, 210029
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Nanning, China, 530021
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Shanghai, China, 200032
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Shanghai, China, 200030
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Shanghai, China, 200072
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Shenyang, China, 110001
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Suzhou, China, 215006
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Tianjin, China, 300060
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Tianjin, China, 300051
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Tianjin, China, 300052
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Urumqi, China, 830000
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Xi'an, China, 710061
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Xiamen, China, 361004
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Yangzhou, China, 225001
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Zhengzhou, China, 450008
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Ürümqi, China, 830000
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Bron, France, 69677
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Lille, France, 59000
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Limoges Cedex, France, 87042
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Lyon, France, 69008
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Paris, France, 75020
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Aachen, Germany, 52074
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Berlin, Germany, 13125
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Berlin, Germany, 12351
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Berlin, Germany, 13359
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Coswig, Germany, 01640
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Gauting, Germany, 82131
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Gerlingen, Germany, 70839
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Großhansdorf, Germany, 22927
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Halle, Germany, 06120
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Hamburg, Germany, 20251
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Homburg, Germany, 66421
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Immenhausen, Germany, 34376
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Kassel, Germany, 34125
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Köln, Germany, 51109
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Lübeck, Germany, 23538
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Würzburg, Germany, 97074
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong, 150001
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King's Park, Hong Kong, 150001
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Budapest, Hungary, 1083
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Budapest, Hungary, 1121
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Deszk, Hungary, 6772
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Székesfehérvár, Hungary, 8000
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Törökbálint, Hungary, 2045
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Beer-Sheva, Israel, 8410101
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Haifa, Israel, 31999
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Jerusalem, Israel, 91120
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Kfar-Saba, Israel, 4428164
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Petah Tikva, Israel, 4941492
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Ramat Gan, Israel, 5262000
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Tel Aviv, Israel, 6423906
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Bari, Italy, 70124
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Bergamo, Italy, 24127
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Bologna, Italy, 40138
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Cremona, Italy, 26100
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Firenze, Italy, 50134
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Lucca, Italy, 55100
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Meldola, Italy, 47014
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Milano, Italy, 20141
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Milano, Italy, 20132
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Milano, Italy, 20162
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Novara, Italy, 28100
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Orbassano, Italy, 10043
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Padova, Italy, 35128
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Parma, Italy, 43126
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Roma, Italy, 00152
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Bunkyo-ku, Japan, 113-8431
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Fukuoka, Japan, 812-8582
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Hirakata-shi, Japan, 573-1191
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Hiroshima-shi, Japan, 730-8518
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Hiroshima-shi, Japan, 734-8551
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Kanazawa, Japan, 920-8641
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Kashiwa, Japan, 277-8577
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Kitakyushu-shi, Japan, 807-8555
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Kobe-shi, Japan, 650-0047
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Kurume-shi, Japan, 830-0011
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Matsuyama-shi, Japan, 791-0280
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Nagoya-shi, Japan, 453-8511
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Niigata-shi, Japan, 951-8566
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Osakasayama-shi, Japan, 589-8511
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Sagamihara-shi, Japan, 252-0375
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Sakai-shi, Japan, 591-8555
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Sasebo-shi, Japan, 857-8511
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Sendai-shi, Japan, 980-0873
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Shinjuku-ku, Japan, 160-0023
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Sunto-gun, Japan, 411-8777
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Ube-shi, Japan, 755-0241
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Yokohama-shi, Japan, 241-8515
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Yokohama-shi, Japan, 240-8555
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Yonago-shi, Japan, 683-8504
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Cheongju-si, Korea, Republic of, 28644
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Seoul, Korea, Republic of, 156-707
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Seoul, Korea, Republic of, 02841
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Seoul, Korea, Republic of, 6351
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Seoul, Korea, Republic of, 05030
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Seoul, Korea, Republic of, 138-736
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Suwon, Korea, Republic of, 16499
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Suwon, Korea, Republic of, 16247
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Amsterdam, Netherlands, 1081 HV
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Arnhem, Netherlands, 6815 AD
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Hoofddorp, Netherlands, 2134 TM
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Zwolle, Netherlands, 8025 AB
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Kraków, Poland, 31-202
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Otwock, Poland, 05-400
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Poznan, Poland, 60-569
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Poznań, Poland, 60-569
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Racibórz, Poland, 47-400
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Warszawa, Poland, 02-781
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Wieliszew, Poland, 05-135
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Łódź, Poland, 90-302
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Bucharest, Romania, 050098
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Bucuresti, Romania, 031422
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Cluj Napoca, Romania, 400015
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Craiova, Romania, 200385
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Focsani, Romania, 620165
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Iasi, Romania, 700483
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Timisoara, Romania, 300210
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Arkhangelsk, Russian Federation, 163045
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Kazan, Russian Federation, 420029
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 143423
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Obninsk, Russian Federation, 249036
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Omsk, Russian Federation, 644013
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Pyatigorsk, Russian Federation, 357502
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Rostov-on-Don, Russian Federation, 344037
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Ryazan, Russian Federation, 390011
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Saint Petersburg, Russian Federation, 195271
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Saint Petersburg, Russian Federation, 194291
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Saint Petersburg, Russian Federation, 198255
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Saint-Petersburg, Russian Federation, 197758
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Sankt-Peterburg, Russian Federation, 197758
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St. Petersburg, Russian Federation, 197022
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A Coruña, Spain, 15006
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Barcelona, Spain, 08041
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Elche, Spain, 03203
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Las Palmas de Gran Canaria, Spain, 35016
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Madrid, Spain, 28046
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Madrid, Spain, 28040
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Madrid, Spain, 08035
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Madrid, Spain, 28007
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Majadahonda, Spain, 28222
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Málaga, Spain, 29010
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San Sebastian, Spain, 20014
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Valencia, Spain, 46010
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Valencia, Spain, 46026
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Zaragoza, Spain, 50009
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Linköping, Sweden, 581 85
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Changhua, Taiwan, 50006
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Putzu City, Taiwan, 0613
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Taichung, Taiwan, 40705
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Taichung City, Taiwan, 402
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Tainan, Taiwan, 70403
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Tainan City, Taiwan, 73657
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 112
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Tao-Yuan, Taiwan, 333
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Bangkok, Thailand, 10330
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Bangkok, Thailand, 10700
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Chiang Rai, Thailand, 57000
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Khon Kaen, Thailand, 40002
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Mueang, Thailand, 50200
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Phitsanulok, Thailand, 65000
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Songkla, Thailand, 90110
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Ankara, Turkey, 06280
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Ankara, Turkey, 6500
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Bursa, Turkey, 16059
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Istanbul, Turkey, 34098
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Istanbul, Turkey, 34069
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Istanbul, Turkey, 34093
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Istanbul, Turkey, 34722
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Izmir, Turkey, 35100
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Dnipro, Ukraine, 49102
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Lviv, Ukraine, 79031
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Sumy, Ukraine, 40022
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Uzhhorod, Ukraine, 88000
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Vinnytsia, Ukraine, 21029
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Zaporizhzhia, Ukraine, 69040
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California
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Los Angeles, California, United States, 90048
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Santa Monica, California, United States, 90404
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Santa Rosa, California, United States, 95403
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Torrance, California, United States, 90505
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Colorado
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Grand Junction, Colorado, United States, 81501
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Connecticut
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New Haven, Connecticut, United States, 06520
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Norwalk, Connecticut, United States, 06856
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Florida
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Fort Myers, Florida, United States, 33901
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Pembroke Pines, Florida, United States, 33028
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Saint Petersburg, Florida, United States, 33705
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Georgia
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Athens, Georgia, United States, 30607
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Hawaii
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Honolulu, Hawaii, United States, 96819
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Illinois
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Chicago, Illinois, United States, 60612
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Elk Grove Village, Illinois, United States, 60007
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Maryland
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Bethesda, Maryland, United States, 20817
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New Jersey
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Brick, New Jersey, United States, 08724
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Florham Park, New Jersey, United States, 07932
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New York
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Mineola, New York, United States, 11501
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Rhode Island
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Pawtucket, Rhode Island, United States, 02860
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Tennessee
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Chattanooga, Tennessee, United States, 37404
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Nashville, Tennessee, United States, 37203
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Texas
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San Antonio, Texas, United States, 78229
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Virginia
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Fort Belvoir, Virginia, United States, 22060
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Hanoi, Vietnam, 100000
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Hanoi, Vietnam, 10000
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Ho Chi Minh, Vietnam, 70000
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female, aged at least 18 years.
- Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology
- MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
- Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria.
- Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.
- Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.
- Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
- World Health Organization Performance Status of 0 to 1.
- Female patients should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-child-bearing potential.
Exclusion Criteria:
Treatment with any of the following:
- Pre-operative or post-operative or planned radiation therapy for the current lung cancer
- Pre-operative (neo-adjuvant) platinum based or other chemotherapy
- Any prior anticancer therapy
- Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time
- Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug
- Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4
- Treatment with an investigational drug within five half-lives of the compound or any of its related material.
- Patients who have had only segmentectomies or wedge resections
- History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.
Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- Inadequate bone marrow reserve or organ function.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AZD9291
AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
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The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.
Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.
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Placebo Comparator: Placebo AZD9291
Matching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
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The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
Time Frame: From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years.
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Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence)
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From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
Time Frame: From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years and 3 years.
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Defined as the percentage of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis
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From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years and 3 years.
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Overall Survival (OS)
Time Frame: From date of randomization until date of death due to any cause, up to approximately 4 years.
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Defined as the time from the date of randomization until date of death due to any cause.
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From date of randomization until date of death due to any cause, up to approximately 4 years.
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Overall Survival (OS)
Time Frame: From date of randomization until date of death due to any cause, up to approximately 4 years.
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Defined as the time from the date of randomization until date of death due to any cause
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From date of randomization until date of death due to any cause, up to approximately 4 years.
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Overall Survival Rate at 2, 3 and 5 Years
Time Frame: From date of randomization until date of death due to any cause, up to approximately 4 years. Assessed at 2 years and 3 years.
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Defined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
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From date of randomization until date of death due to any cause, up to approximately 4 years. Assessed at 2 years and 3 years.
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Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Time Frame: Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to approximately 3 years.
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Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment.
The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS).
Final scores for each scale range from 0-100 with higher scores indicating better health.
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Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to approximately 3 years.
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Plasma Concentrations of AZD9291
Time Frame: Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)
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The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291
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Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)
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Plasma Concentrations of AZ5104 Metabolites
Time Frame: From date of dosing to week 96 (approximately 24 months)
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The pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 metabolites
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From date of dosing to week 96 (approximately 24 months)
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Plasma Concentrations of AZ7550 Metabolites
Time Frame: From date of dosing to week 96 (approximately 24 months)
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The pharmacokinetics exposure parameters derived from plasma concentrations of AZ7550 metabolites
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From date of dosing to week 96 (approximately 24 months)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Majem M, Goldman JW, John T, Grohe C, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Li S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Atagi S, Zeng L, Kulkarni D, Medic N, Tsuboi M, Herbst RS, Wu YL. Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial. Clin Cancer Res. 2022 Jun 1;28(11):2286-2296. doi: 10.1158/1078-0432.CCR-21-3530.
- Wu YL, John T, Grohe C, Majem M, Goldman JW, Kim SW, Kato T, Laktionov K, Vu HV, Wang Z, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Atasoy A, Herbst RS, Tsuboi M. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC. J Thorac Oncol. 2022 Mar;17(3):423-433. doi: 10.1016/j.jtho.2021.10.014. Epub 2021 Nov 2.
- Wu YL, Tsuboi M, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(35):4827-4835. doi: 10.2217/fon-2021-0752. Epub 2021 Nov 1.
- Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.
- Wu YL, Herbst RS, Mann H, Rukazenkov Y, Marotti M, Tsuboi M. ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection. Clin Lung Cancer. 2018 Jul;19(4):e533-e536. doi: 10.1016/j.cllc.2018.04.004. Epub 2018 May 1.
- Herbst RS, Wu YL, Tsuboi M. Osimertinib in EGFR-Mutated Lung Cancer. Reply. N Engl J Med. 2021 Feb 18;384(7):675-676. doi: 10.1056/NEJMc2033951. No abstract available.
Helpful Links
- Cancer
- Lung Cancer
- EGFR mutation
- Stage IB non-small cell lung cancer
- Stage II non-small cell lung cancer
- Stage IIIA non-small cell lung cancer
- Adjuvant chemotherapy in non-small cancer
- Complete tumour resection in non-small cancer
- EGFR sensitivity
- EGFR inhibitors
- FDA Drug and Device Resources
- Redacted SAP
- Redacted CSP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Osimertinib
Other Study ID Numbers
- D5164C00001
- 2015-000662-65 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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