AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy. (ADAURA)

July 25, 2023 updated by: AstraZeneca

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).

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

Study Overview

Detailed Description

This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of AZD9291 versus placebo in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy. Adjuvant chemotherapy should have consisted of a platinum based doublet given for a maximum of 4 cycles.

Study Type

Interventional

Enrollment (Actual)

682

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bedford Park, Australia, 5042
        • Research Site
      • Camperdown, Australia, 2050
        • Research Site
      • Darlinghurst, Australia, 2010
        • Research Site
      • Heidelberg, Australia, 3084
        • Research Site
      • Kogarah, Australia, 2217
        • Research Site
      • Kurralta Park, Australia, 5037
        • Research Site
      • Woolloongabba, Australia, 4102
        • Research Site
      • Brussel, Belgium, 1200
        • Research Site
      • Brussels, Belgium, 1090
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Kortrijk, Belgium, 8500
        • Research Site
      • Barretos, Brazil, 14784-400
        • Research Site
      • Cachoeira De Itapemirim, Brazil, 29308-055
        • Research Site
      • Curitiba, Brazil, 81520-060
        • Research Site
      • Florianópolis, Brazil, 88034-000
        • Research Site
      • Fortaleza, Brazil, 60810-180
        • Research Site
      • Lajeado, Brazil, 95900000
        • Research Site
      • Porto Alegre, Brazil, 90619-900
        • Research Site
      • Rio de Janeiro, Brazil, 22793-080
        • Research Site
      • Salvador, Brazil, 40170-110
        • Research Site
      • São José do Rio Preto, Brazil, 15025-100
        • Research Site
      • São Paulo, Brazil, 01321-001
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
      • Beijing, China, 100142
        • Research Site
      • Beijing, China, 100730
        • Research Site
      • Beijing, China, 100029
        • Research Site
      • Beijing, China, 100210
        • Research Site
      • Changchun, China, 130012
        • Research Site
      • Changchun, China, 130021
        • Research Site
      • Dalian, China, 116027
        • Research Site
      • Guangzhou, China, 510120
        • Research Site
      • Guangzhou, China, 510180
        • Research Site
      • Guangzhou, China, 510060
        • Research Site
      • Hangzhou, China, 310022
        • Research Site
      • Hangzhou, China, 310003
        • Research Site
      • Hangzhou, China, 310009
        • Research Site
      • Kunming, China, 650118
        • Research Site
      • 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
        • Research Site
      • 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
        • Research Site
      • 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
        • Research Site
      • Focsani, Romania, 620165
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      • Iasi, Romania, 700483
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      • Timisoara, Romania, 300210
        • Research Site
      • Arkhangelsk, Russian Federation, 163045
        • Research Site
      • Kazan, Russian Federation, 420029
        • Research Site
      • Moscow, Russian Federation, 115478
        • Research Site
      • Moscow, Russian Federation, 143423
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      • Obninsk, Russian Federation, 249036
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      • Omsk, Russian Federation, 644013
        • Research Site
      • Pyatigorsk, Russian Federation, 357502
        • Research Site
      • Rostov-on-Don, Russian Federation, 344037
        • Research Site
      • Ryazan, Russian Federation, 390011
        • Research Site
      • Saint Petersburg, Russian Federation, 195271
        • Research Site
      • Saint Petersburg, Russian Federation, 194291
        • Research Site
      • Saint Petersburg, Russian Federation, 198255
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      • Saint-Petersburg, Russian Federation, 197758
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      • Sankt-Peterburg, Russian Federation, 197758
        • Research Site
      • St. Petersburg, Russian Federation, 197022
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      • A Coruña, Spain, 15006
        • Research Site
      • Barcelona, Spain, 08041
        • Research Site
      • Elche, Spain, 03203
        • Research Site
      • Las Palmas de Gran Canaria, Spain, 35016
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Madrid, Spain, 08035
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      • Madrid, Spain, 28007
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      • Majadahonda, Spain, 28222
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      • Málaga, Spain, 29010
        • Research Site
      • San Sebastian, Spain, 20014
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      • Valencia, Spain, 46010
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      • Valencia, Spain, 46026
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
      • Linköping, Sweden, 581 85
        • Research Site
      • Changhua, Taiwan, 50006
        • Research Site
      • 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
        • Research Site
      • Tainan City, Taiwan, 73657
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 112
        • Research Site
      • Tao-Yuan, Taiwan, 333
        • Research Site
      • Bangkok, Thailand, 10330
        • Research Site
      • Bangkok, Thailand, 10700
        • Research Site
      • Chiang Rai, Thailand, 57000
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
      • Mueang, Thailand, 50200
        • Research Site
      • Phitsanulok, Thailand, 65000
        • Research Site
      • Songkla, Thailand, 90110
        • Research Site
      • Ankara, Turkey, 06280
        • Research Site
      • Ankara, Turkey, 6500
        • Research Site
      • Bursa, Turkey, 16059
        • Research Site
      • Istanbul, Turkey, 34098
        • Research Site
      • Istanbul, Turkey, 34069
        • Research Site
      • Istanbul, Turkey, 34093
        • Research Site
      • Istanbul, Turkey, 34722
        • Research Site
      • Izmir, Turkey, 35100
        • Research Site
      • Dnipro, Ukraine, 49102
        • Research Site
      • Lviv, Ukraine, 79031
        • Research Site
      • Sumy, Ukraine, 40022
        • Research Site
      • Uzhhorod, Ukraine, 88000
        • Research Site
      • Vinnytsia, Ukraine, 21029
        • Research Site
      • Zaporizhzhia, Ukraine, 69040
        • Research Site
    • California
      • Los Angeles, California, United States, 90048
        • Research Site
      • Santa Monica, California, United States, 90404
        • Research Site
      • Santa Rosa, California, United States, 95403
        • Research Site
      • Torrance, California, United States, 90505
        • Research Site
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Research Site
      • Norwalk, Connecticut, United States, 06856
        • Research Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Research Site
      • Pembroke Pines, Florida, United States, 33028
        • Research Site
      • Saint Petersburg, Florida, United States, 33705
        • Research Site
    • Georgia
      • Athens, Georgia, United States, 30607
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Elk Grove Village, Illinois, United States, 60007
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Research Site
      • Florham Park, New Jersey, United States, 07932
        • Research Site
    • New York
      • Mineola, New York, United States, 11501
        • Research Site
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Fort Belvoir, Virginia, United States, 22060
        • Research Site
      • Hanoi, Vietnam, 100000
        • Research Site
      • Hanoi, Vietnam, 10000
        • Research Site
      • Ho Chi Minh, Vietnam, 70000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female, aged at least 18 years.
  2. Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology
  3. MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
  4. Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria.
  5. 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.
  6. 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.
  7. Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
  8. World Health Organization Performance Status of 0 to 1.
  9. 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:

  1. 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.
  2. Patients who have had only segmentectomies or wedge resections
  3. 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.
  4. 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.
  5. 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).
  6. 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.
  7. 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.
  8. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
  9. Inadequate bone marrow reserve or organ function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: AZD9291
AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
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.
Placebo Comparator: Placebo AZD9291
Matching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Overall Survival (OS)
Time Frame: From date of randomization until date of death due to any cause, up to approximately 4 years.
Defined as the time from the date of randomization until date of death due to any cause.
From date of randomization until date of death due to any cause, up to approximately 4 years.
Overall Survival (OS)
Time Frame: From date of randomization until date of death due to any cause, up to approximately 4 years.
Defined as the time from the date of randomization until date of death due to any cause
From date of randomization until date of death due to any cause, up to approximately 4 years.
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.
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
From date of randomization until date of death due to any cause, up to approximately 4 years. Assessed at 2 years and 3 years.
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.
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.
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.
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)
The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291
Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)
Plasma Concentrations of AZ5104 Metabolites
Time Frame: From date of dosing to week 96 (approximately 24 months)
The pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 metabolites
From date of dosing to week 96 (approximately 24 months)
Plasma Concentrations of AZ7550 Metabolites
Time Frame: From date of dosing to week 96 (approximately 24 months)
The pharmacokinetics exposure parameters derived from plasma concentrations of AZ7550 metabolites
From date of dosing to week 96 (approximately 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2015

Primary Completion (Actual)

January 17, 2020

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (Estimated)

July 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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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