AZD9291 versus Placebo in patients with stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy.  (ADAURA)

Recruitment Status:
Active, not recruiting

Sponsor:
AstraZeneca

Information Provided by (Responsible Party):
AstraZeneca

ClinicalTrials.gov Identifier:
NCT02511106

Verification:
Verified 01 October 2020   by AstraZeneca

History of Changes:
ClinicalTrials.gov

Purpose

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

Official Title: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 Type:Interventional
Overall Recruitment Status:Active, not recruiting
Study Start Date:21 October 2015
Study Start Date Type:Actual
Primary Completion Date:17 January 2020
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind   (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
ConditionInterventionPhase
Stage IB-IIIA non-small cell lung carcinoma
Drug: AZD9291 80 mg/40 mg
Drug: Placebo AZD9291 80 mg/40 mg
Phase 3
Ages Eligible for Study: 18 Years  to 130 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

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.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    information.center@astrazeneca.com  
Contact Backup: AstraZeneca Cancer Study Locator Service  http://www.emergingmed.com/networks/AstraZeneca   1-877-400-4656    astrazeneca@emergingmed.com  

Sponsors and Collaborators

AstraZeneca


Locations

CountryLocationFacilityContactStatus
Canada , ONResearch Site Brampton, ON, Canada, L6R 3J7Withdrawn
Canada , ONResearch Site Toronto, ON, Canada, M5G 2M9Active, not recruiting
Canada , NBResearch Site Moncton, NB, Canada, E1C 6Z8Withdrawn
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90048Active, not recruiting
United States of America , CAResearch Site Santa Monica, CA, United States of America, 90404-2125Active, not recruiting
United States of America , CAResearch Site Santa Rosa, CA, United States of America, 95403Active, not recruiting
United States of America , CAResearch Site Torrance, CA, United States of America, 90505Active, not recruiting
JapanResearch Site Bunkyo-ku, Japan, 113-8431Active, not recruiting
JapanResearch Site Fukuoka, Japan, 812-8582Active, not recruiting
JapanResearch Site Hirakata-shi, Japan, 573-1191Active, not recruiting
JapanResearch Site Hiroshima-shi, Japan, 734-8551Active, not recruiting
JapanResearch Site Hiroshima-shi, Japan, 730-8518Active, not recruiting
JapanResearch Site Kanazawa, Japan, 920-8641Active, not recruiting
JapanResearch Site Kashiwa, Japan, 277-8577Active, not recruiting
JapanResearch Site Kitakyushu-shi, Japan, 807-8555Active, not recruiting
JapanResearch Site Kobe-shi, Japan, 650-0047Active, not recruiting
JapanResearch Site Kurume-shi, Japan, 830-0011Active, not recruiting
JapanResearch Site Matsuyama-shi, Japan, 791-0280Active, not recruiting
JapanResearch Site Nagoya-shi, Japan, 453-8511Active, not recruiting
JapanResearch Site Niigata-shi, Japan, 951-8566Active, not recruiting
JapanResearch Site Osakasayama-shi, Japan, 589-8511Active, not recruiting
JapanResearch Site Osaka-shi, Japan, 541-8567Withdrawn
JapanResearch Site Sagamihara-shi, Japan, 252-0375Active, not recruiting
JapanResearch Site Sakai-shi, Japan, 591-8555Active, not recruiting
JapanResearch Site Sasebo-shi, Japan, 857-8511Active, not recruiting
JapanResearch Site Sendai-shi, Japan, 980-0873Active, not recruiting
JapanResearch Site Shinjuku-ku, Japan, 160-0023Active, not recruiting
JapanResearch Site Sunto-gun, Japan, 411-8777Active, not recruiting
JapanResearch Site Ube-shi, Japan, 755-0241Active, not recruiting
JapanResearch Site Yokohama-shi, Japan, 240-8555Active, not recruiting
JapanResearch Site Yokohama-shi, Japan, 241-8515Active, not recruiting
JapanResearch Site Yokohama-shi, Japan, 236-0051Withdrawn
JapanResearch Site Yonago-shi, Japan, 683-8504Active, not recruiting
SpainResearch Site A Coruña, Spain, 15006Completed
SpainResearch Site Barcelona, Spain, 08041Active, not recruiting
SpainResearch Site Barcelona, Spain, 08035Active, not recruiting
SpainResearch Site Elche, Spain, 03203Completed
SpainResearch Site Las Palmas de Gran Canaria, Spain, 35016Active, not recruiting
SpainResearch Site Madrid, Spain, 28007Active, not recruiting
SpainResearch Site Madrid, Spain, 28040Active, not recruiting
SpainResearch Site Madrid, Spain, 28046Completed
SpainResearch Site Madrid, Spain, 28040Active, not recruiting
SpainResearch Site Majadahonda, Spain, 28222Active, not recruiting
SpainResearch Site Málaga, Spain, 29010Active, not recruiting
SpainResearch Site San Sebastian, Spain, 20014Active, not recruiting
SpainResearch Site Valencia, Spain, 46026Completed
SpainResearch Site Valencia, Spain, 46010Active, not recruiting
SpainResearch Site Zaragoza, Spain, 50009Active, not recruiting
BrazilResearch Site Barretos, Brazil, 14784-400Active, not recruiting
BrazilResearch Site Cachoeira De Itapemirim, Brazil, 29308-055Completed
BrazilResearch Site Curitiba, Brazil, 81520-060Active, not recruiting
BrazilResearch Site Florianópolis, Brazil, 88034-000Active, not recruiting
BrazilResearch Site Fortaleza, Brazil, 60810-180Active, not recruiting
BrazilResearch Site Porto Alegre, Brazil, 90619-900Completed
BrazilResearch Site Rio de Janeiro, Brazil, 22793-080Active, not recruiting
BrazilResearch Site Rio Grande do Sul, Brazil, 95900000Completed
BrazilResearch Site Salvador, Brazil, 40170-110Completed
BrazilResearch Site Salvador, Brazil, 41950-610Withdrawn
BrazilResearch Site Santa Catarina, Brazil, 88301-220Withdrawn
BrazilResearch Site Santo André, Brazil, 09060-650Withdrawn
BrazilResearch Site São José do Rio Preto, Brazil, 15025-100Completed
BrazilResearch Site São Paulo, Brazil, 01321-001Completed
BrazilResearch Site São Paulo, Brazil, 04039-031Withdrawn
PolandResearch Site Kraków, Poland, 31-202Completed
PolandResearch Site Łódź, Poland, 90-302Active, not recruiting
PolandResearch Site Otwock, Poland, 05-400Active, not recruiting
PolandResearch Site Poznan, Poland, 60-569Completed
PolandResearch Site Poznań, Poland, 60-569Active, not recruiting
PolandResearch Site Racibórz, Poland, 47-400Active, not recruiting
PolandResearch Site Warszawa, Poland, 02-781Active, not recruiting
PolandResearch Site Wieliszew, Poland, 05-135Active, not recruiting
FranceResearch Site Bron, France, 69677Active, not recruiting
FranceResearch Site Lille, France, 59000Active, not recruiting
FranceResearch Site Limoges, France, 87042Not Yet Recruiting
FranceResearch Site Lyon, France, 69008Active, not recruiting
FranceResearch Site PARIS, France, 75020Active, not recruiting
ItalyResearch Site Bari, Italy, 70124Active, not recruiting
ItalyResearch Site Bergamo, Italy, 24127Active, not recruiting
ItalyResearch Site Bologna, Italy, 40138Active, not recruiting
ItalyResearch Site Cremona, Italy, 26100Completed
ItalyResearch Site Firenze, Italy, 50134Active, not recruiting
ItalyResearch Site Livorno, Italy, 57124Withdrawn
ItalyResearch Site Lucca, Italy, 55100Completed
ItalyResearch Site Meldola, Italy, 47014Active, not recruiting
ItalyResearch Site Milano, Italy, 20132Completed
ItalyResearch Site Milano, Italy, 20162Completed
ItalyResearch Site MILANO, Italy, 20141Active, not recruiting
ItalyResearch Site NOVARA, Italy, 28100Active, not recruiting
ItalyResearch Site Orbassano, Italy, 10043Active, not recruiting
ItalyResearch Site PADOVA, Italy, 35128Active, not recruiting
ItalyResearch Site Palermo, Italy, 90127Withdrawn
ItalyResearch Site Parma, Italy, 43100Active, not recruiting
ItalyResearch Site Rimini, Italy, 47900Withdrawn
ItalyResearch Site Roma, Italy, 00152Completed
GermanyResearch Site Aachen, Germany, 52074Completed
GermanyResearch Site Berlin, Germany, 13125Active, not recruiting
GermanyResearch Site Berlin, Germany, 12351Active, not recruiting
GermanyResearch Site Berlin, Germany, 13359Active, not recruiting
GermanyResearch Site Coswig, Germany, 01640Terminated
GermanyResearch Site Gauting, Germany, 82131Terminated
GermanyResearch Site Gerlingen, Germany, 70839Active, not recruiting
GermanyResearch Site Großhansdorf, Germany, 22927Active, not recruiting
GermanyResearch Site Halle, Germany, 06120Active, not recruiting
GermanyResearch Site Hamburg, Germany, 20251Completed
GermanyResearch Site Homburg, Germany, 66421Terminated
GermanyResearch Site Immenhausen, Germany, 34376Active, not recruiting
GermanyResearch Site Kassel, Germany, 34125Completed
GermanyResearch Site Köln, Germany, 51109Active, not recruiting
GermanyResearch Site Lübeck, Germany, 23538Active, not recruiting
GermanyResearch Site München, Germany, 81925Withdrawn
GermanyResearch Site Trier, Germany, 54290Withdrawn
GermanyResearch Site Würzburg, Germany, 97074Active, not recruiting
TaiwanResearch Site Changhua, Taiwan, 50006Active, not recruiting
TaiwanResearch Site Kaohsiung, Taiwan, 83301Withdrawn
TaiwanResearch Site Putzu City, Taiwan, 0613Active, not recruiting
TaiwanResearch Site Taichung, Taiwan, 40705Active, not recruiting
TaiwanResearch Site Taichung City, Taiwan, 402Active, not recruiting
TaiwanResearch Site Tainan, Taiwan, 70403Active, not recruiting
TaiwanResearch Site Tainan City, Taiwan, 73657Active, not recruiting
TaiwanResearch Site Taipei, Taiwan, 112Active, not recruiting
TaiwanResearch Site Taipei, Taiwan, 10002Active, not recruiting
TaiwanResearch Site Taipei, Taiwan, 235Withdrawn
TaiwanResearch Site Tao-Yuan, Taiwan, 333Active, not recruiting
AustraliaResearch Site Bedford Park, Australia, 5042Active, not recruiting
AustraliaResearch Site Camperdown, Australia, 2050Active, not recruiting
AustraliaResearch Site Darlinghurst, Australia, 2010Active, not recruiting
AustraliaResearch Site Frankston, Australia, 3199Withdrawn
AustraliaResearch Site Heidelberg, Australia, 3084Active, not recruiting
AustraliaResearch Site Kogarah, Australia, 2217Active, not recruiting
AustraliaResearch Site Kurralta Park, Australia, 5037Active, not recruiting
AustraliaResearch Site Woolloongabba, Australia, 4102Active, not recruiting
BelgiumResearch Site Baudour, Belgium, 7331Withdrawn
BelgiumResearch Site Brussels, Belgium, 1090Active, not recruiting
BelgiumResearch Site Brussels, Belgium, 1200Suspended
BelgiumResearch Site Brussels, Belgium, 1070Withdrawn
BelgiumResearch Site Bruxelles, Belgium, 1000Withdrawn
BelgiumResearch Site Gent, Belgium, 9000Suspended
BelgiumResearch Site Kortrijk, Belgium, 8500Suspended
BelgiumResearch Site Ottignies, Belgium, 1340Suspended
RomaniaResearch Site Bucharest, Romania, 050098Completed
RomaniaResearch Site Bucuresti, Romania, 031422Completed
RomaniaResearch Site Cluj Napoca, Romania, 400015Active, not recruiting
RomaniaResearch Site Craiova, Romania, 200385Completed
RomaniaResearch Site Focsani, Romania, 620165Completed
RomaniaResearch Site Iasi, Romania, 700483Active, not recruiting
RomaniaResearch Site Timisoara, Romania, 300210Completed
Russian FederationResearch Site Arkhangelsk, Russian Federation, 163045Active, not recruiting
Russian FederationResearch Site Kazan, Russian Federation, 420029Active, not recruiting
Russian FederationResearch Site Moscow, Russian Federation, 115478Completed
Russian FederationResearch Site Moscow, Russian Federation, 115478Active, not recruiting
Russian FederationResearch Site MOSCOW, Russian Federation, 143423Active, not recruiting
Russian FederationResearch Site Obninsk, Russian Federation, 249036Active, not recruiting
Russian FederationResearch Site Omsk, Russian Federation, 644013Active, not recruiting
Russian FederationResearch Site Omsk, Russian Federation, 644013Active, not recruiting
Russian FederationResearch Site Pyatigorsk, Russian Federation, 357502Active, not recruiting
Russian FederationResearch Site Rostov-on-Don, Russian Federation, 344037Active, not recruiting
Russian FederationResearch Site Ryazan, Russian Federation, 390011Active, not recruiting
Russian FederationResearch Site Saint Petersburg, Russian Federation, 198255Active, not recruiting
Russian FederationResearch Site Saint Petersburg, Russian Federation, 194291Terminated
Russian FederationResearch Site Saint Petersburg, Russian Federation, 195271Active, not recruiting
Russian FederationResearch Site Saint-Petersburg, Russian Federation, 197758Active, not recruiting
Russian FederationResearch Site Sankt-Peterburg, Russian Federation, 197758Active, not recruiting
Russian FederationResearch Site St. Petersburg, Russian Federation, 197022Active, not recruiting
ThailandResearch Site Bangkok, Thailand, 10330Active, not recruiting
ThailandResearch Site Bangkok, Thailand, 10700Active, not recruiting
ThailandResearch Site Khon Kaen, Thailand, 40002Active, not recruiting
ThailandResearch Site Muang, Thailand, 57000Active, not recruiting
ThailandResearch Site Muang, Thailand, 50200Active, not recruiting
ThailandResearch Site Phitsanulok, Thailand, 65000Active, not recruiting
ThailandResearch Site Songkla, Thailand, 90110Active, not recruiting
South KoreaResearch Site Cheongju-si, South Korea, 28644Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 02841Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 135-710Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 05030Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 05505Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 156-707Active, not recruiting
South KoreaResearch Site Suwon, South Korea, 16499Active, not recruiting
South KoreaResearch Site Suwon-si, South Korea, 16247Active, not recruiting
NetherlandsResearch Site Amsterdam, Netherlands, 1081 HVTerminated
NetherlandsResearch Site ARNHEM, Netherlands, 6815 ADTerminated
NetherlandsResearch Site ASSEN, Netherlands, 9401 RKWithdrawn
NetherlandsResearch Site Eindhoven, Netherlands, 5623EJWithdrawn
NetherlandsResearch Site HOOFDDORP, Netherlands, 2134 TMTerminated
NetherlandsResearch Site Zwolle, Netherlands, 8025 ABTerminated
United States of America , UTResearch Site Salt Lake City, UT, United States of America, 84106Withdrawn
United States of America , HIResearch Site Honolulu, HI, United States of America, 96819Active, not recruiting
United States of America , VAResearch Site Fort Belvoir, VA, United States of America, 22060Active, not recruiting
United States of America , GAResearch Site Athens, GA, United States of America, 30607Completed
United States of America , CTResearch Site New Haven, CT, United States of America, 06520Active, not recruiting
United States of America , CTResearch Site Norwalk, CT, United States of America, 06856Completed
United States of America , MDResearch Site Bethesda, MD, United States of America, 20817Completed
VietnamResearch Site Ha Noi, Vietnam, 100000Active, not recruiting
VietnamResearch Site Hanoi City, Vietnam, 100000Active, not recruiting
VietnamResearch Site Ho Chi Minh, Vietnam, 700000Active, not recruiting
VietnamResearch Site Ho Chi Minh, Vietnam, 70000Active, not recruiting
United States of America , LAResearch Site Marrero, LA, United States of America, 70072Withdrawn
United States of America , ILResearch Site Chicago, IL, United States of America, 60612Active, not recruiting
United States of America , ILResearch Site Elk Grove Village, IL, United States of America, 60007Terminated
United States of America , RIResearch Site Pawtucket, RI, United States of America, 02860Completed
United States of America , NJResearch Site Brick, NJ, United States of America, 08724Completed
United States of America , NJResearch Site Florham Park, NJ, United States of America, 07932Active, not recruiting
Hong KongResearch Site Hong Kong, Hong Kong, Active, not recruiting
Hong KongResearch Site Hong Kong, Hong Kong, 150001Active, not recruiting
Hong KongResearch Site King's Park, Hong Kong, 150001Active, not recruiting
HungaryResearch Site Budapest, Hungary, 1083Completed
HungaryResearch Site Budapest, Hungary, 1121Completed
HungaryResearch Site Deszk, Hungary, 6772Active, not recruiting
HungaryResearch Site Székesfehérvár, Hungary, 8000Completed
HungaryResearch Site Törökbálint, Hungary, 2045Completed
TurkeyResearch Site Ankara, Turkey, 6500Completed
TurkeyResearch Site Ankara, Turkey, 06280Active, not recruiting
TurkeyResearch Site Bursa, Turkey, 16059Active, not recruiting
TurkeyResearch Site Diyarbakir, Turkey, 21280Withdrawn
TurkeyResearch Site Istanbul, Turkey, 34093Active, not recruiting
TurkeyResearch Site Istanbul, Turkey, 34098Active, not recruiting
TurkeyResearch Site Istanbul, Turkey, 34722Active, not recruiting
TurkeyResearch Site Istanbul, Turkey, 34069Active, not recruiting
TurkeyResearch Site Izmir, Turkey, 35575Withdrawn
TurkeyResearch Site Izmir, Turkey, 35100Completed
IsraelResearch Site Beer-Sheva, Israel, 8410101Completed
IsraelResearch Site Haifa, Israel, 31999Active, not recruiting
IsraelResearch Site Jerusalem, Israel, 91120Active, not recruiting
IsraelResearch Site Kfar-Saba, Israel, 4428164Active, not recruiting
IsraelResearch Site Petah Tikva, Israel, 4941492Active, not recruiting
IsraelResearch Site Tel Aviv, Israel, 6423906Completed
IsraelResearch Site Tel Hashomer, Israel, 52621Active, not recruiting
NorwayResearch Site Oslo, Norway, N-0379Withdrawn
SwedenResearch Site LINKÖPING, Sweden, 581 85Active, not recruiting
United States of America , TNResearch Site Chattanooga, TN, United States of America, 37404Completed
United States of America , TNResearch Site Nashville, TN, United States of America, 37203Completed
United States of America , FLResearch Site Ft Myers, FL, United States of America, 33901Completed
United States of America , FLResearch Site Pembroke Pines, FL, United States of America, 33028Completed
United States of America , FLResearch Site St Petersburg, FL, United States of America, 33705Active, not recruiting
ChinaResearch Site Beijing, China, 100210Active, not recruiting
ChinaResearch Site Beijing, China, 100029Active, not recruiting
ChinaResearch Site Changchun, China, 130021Active, not recruiting
ChinaResearch Site Changchun, China, 130012Active, not recruiting
ChinaResearch Site Chongqing, China, 400038Withdrawn
ChinaResearch Site Dalian, China, 116027Active, not recruiting
ChinaResearch Site Fuzhou, China, 350025Withdrawn
ChinaResearch Site Guangzhou, China, 510180Active, not recruiting
ChinaResearch Site Guangzhou, China, 510060Active, not recruiting
ChinaResearch Site Hangzhou, China, 310009Active, not recruiting
ChinaResearch Site Kunming, China, 650118Active, not recruiting
ChinaResearch Site Nanjing, China, 210029Active, not recruiting
ChinaResearch Site Nanning, China, 530021Active, not recruiting
ChinaResearch Site Shanghai, China, 200032Active, not recruiting
ChinaResearch Site Suzhou, China, 215006Withdrawn
ChinaResearch Site Suzhou, China, 215006Active, not recruiting
ChinaResearch Site Tianjin, China, 300060Active, not recruiting
ChinaResearch Site Tianjin, China, 300051Completed
ChinaResearch Site xi'an, China, 710038Withdrawn
ChinaResearch Site Xian, China, 710061Active, not recruiting
ChinaResearch Site Yangzhou, China, 225001Active, not recruiting
ChinaResearch Site Zhengzhou, China, 450008Active, not recruiting
United States of America , COResearch Site Grand Junction, CO, United States of America, 81501Active, not recruiting
UkraineResearch Site Dnipro, Ukraine, 49102Completed
UkraineResearch Site Kyiv, Ukraine, 03115Withdrawn
UkraineResearch Site Lviv, Ukraine, 79031Completed
UkraineResearch Site Sumy, Ukraine, 40022Completed
UkraineResearch Site Uzhhorod, Ukraine, 88000Active, not recruiting
UkraineResearch Site Vinnytsia, Ukraine, 21029Completed
UkraineResearch Site Zaporizhzhia, Ukraine, 69040Active, not recruiting
United States of America , TXResearch Site San Antonio, TX, United States of America, 78229Completed
United States of America , NYResearch Site Mineola, NY, United States of America, 11501Completed

 File nameDescription
CancerCancer
Lung CancerLung Cancer
EGFR mutationEGFR mutation
Stage IB non-small cell lung cancerStage IB non-small cell lung cancer
Stage II non-small cell lung cancerStage II non-small cell lung cancer
Stage IIIA non-small cell lung cancerStage IIIA non-small cell lung cancer
Adjuvant chemotherapy in non-small cancerAdjuvant chemotherapy in non-small cancer
Complete tumour resection in non-small cancerComplete tumour resection in non-small cancer
EGFR sensitivityEGFR sensitivity
EGFR inhibitorsEGFR inhibitors
FDA Drug and Device ResourcesFDA Drug and Device Resources
.

Purpose

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

Official Title: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 Type:Interventional
Overall Recruitment Status:Active, not recruiting
Study Start Date:21 October 2015
Study Start Date Type:Actual
Primary Completion Date:17 January 2020
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind   (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
ConditionInterventionPhase
Stage IB-IIIA non-small cell lung carcinoma
Drug: AZD9291 80 mg/40 mg
Drug: Placebo AZD9291 80 mg/40 mg
Phase 3
Ages Eligible for Study: 18 Years  to 130 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

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.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    information.center@astrazeneca.com  
Contact Backup: AstraZeneca Cancer Study Locator Service  http://www.emergingmed.com/networks/AstraZeneca   1-877-400-4656    astrazeneca@emergingmed.com  

Sponsors and Collaborators

AstraZeneca


Locations

CountryLocationFacilityContactStatus
Canada , ONResearch Site Brampton, ON, Canada, L6R 3J7Withdrawn
Canada , ONResearch Site Toronto, ON, Canada, M5G 2M9Active, not recruiting
Canada , NBResearch Site Moncton, NB, Canada, E1C 6Z8Withdrawn
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90048Active, not recruiting
United States of America , CAResearch Site Santa Monica, CA, United States of America, 90404-2125Active, not recruiting
United States of America , CAResearch Site Santa Rosa, CA, United States of America, 95403Active, not recruiting
United States of America , CAResearch Site Torrance, CA, United States of America, 90505Active, not recruiting
JapanResearch Site Bunkyo-ku, Japan, 113-8431Active, not recruiting
JapanResearch Site Fukuoka, Japan, 812-8582Active, not recruiting
JapanResearch Site Hirakata-shi, Japan, 573-1191Active, not recruiting
JapanResearch Site Hiroshima-shi, Japan, 734-8551Active, not recruiting
JapanResearch Site Hiroshima-shi, Japan, 730-8518Active, not recruiting
JapanResearch Site Kanazawa, Japan, 920-8641Active, not recruiting
JapanResearch Site Kashiwa, Japan, 277-8577Active, not recruiting
JapanResearch Site Kitakyushu-shi, Japan, 807-8555Active, not recruiting
JapanResearch Site Kobe-shi, Japan, 650-0047Active, not recruiting
JapanResearch Site Kurume-shi, Japan, 830-0011Active, not recruiting
JapanResearch Site Matsuyama-shi, Japan, 791-0280Active, not recruiting
JapanResearch Site Nagoya-shi, Japan, 453-8511Active, not recruiting
JapanResearch Site Niigata-shi, Japan, 951-8566Active, not recruiting
JapanResearch Site Osakasayama-shi, Japan, 589-8511Active, not recruiting
JapanResearch Site Osaka-shi, Japan, 541-8567Withdrawn
JapanResearch Site Sagamihara-shi, Japan, 252-0375Active, not recruiting
JapanResearch Site Sakai-shi, Japan, 591-8555Active, not recruiting
JapanResearch Site Sasebo-shi, Japan, 857-8511Active, not recruiting
JapanResearch Site Sendai-shi, Japan, 980-0873Active, not recruiting
JapanResearch Site Shinjuku-ku, Japan, 160-0023Active, not recruiting
JapanResearch Site Sunto-gun, Japan, 411-8777Active, not recruiting
JapanResearch Site Ube-shi, Japan, 755-0241Active, not recruiting
JapanResearch Site Yokohama-shi, Japan, 240-8555Active, not recruiting
JapanResearch Site Yokohama-shi, Japan, 241-8515Active, not recruiting
JapanResearch Site Yokohama-shi, Japan, 236-0051Withdrawn
JapanResearch Site Yonago-shi, Japan, 683-8504Active, not recruiting
SpainResearch Site A Coruña, Spain, 15006Completed
SpainResearch Site Barcelona, Spain, 08041Active, not recruiting
SpainResearch Site Barcelona, Spain, 08035Active, not recruiting
SpainResearch Site Elche, Spain, 03203Completed
SpainResearch Site Las Palmas de Gran Canaria, Spain, 35016Active, not recruiting
SpainResearch Site Madrid, Spain, 28007Active, not recruiting
SpainResearch Site Madrid, Spain, 28040Active, not recruiting
SpainResearch Site Madrid, Spain, 28046Completed
SpainResearch Site Madrid, Spain, 28040Active, not recruiting
SpainResearch Site Majadahonda, Spain, 28222Active, not recruiting
SpainResearch Site Málaga, Spain, 29010Active, not recruiting
SpainResearch Site San Sebastian, Spain, 20014Active, not recruiting
SpainResearch Site Valencia, Spain, 46026Completed
SpainResearch Site Valencia, Spain, 46010Active, not recruiting
SpainResearch Site Zaragoza, Spain, 50009Active, not recruiting
BrazilResearch Site Barretos, Brazil, 14784-400Active, not recruiting
BrazilResearch Site Cachoeira De Itapemirim, Brazil, 29308-055Completed
BrazilResearch Site Curitiba, Brazil, 81520-060Active, not recruiting
BrazilResearch Site Florianópolis, Brazil, 88034-000Active, not recruiting
BrazilResearch Site Fortaleza, Brazil, 60810-180Active, not recruiting
BrazilResearch Site Porto Alegre, Brazil, 90619-900Completed
BrazilResearch Site Rio de Janeiro, Brazil, 22793-080Active, not recruiting
BrazilResearch Site Rio Grande do Sul, Brazil, 95900000Completed
BrazilResearch Site Salvador, Brazil, 40170-110Completed
BrazilResearch Site Salvador, Brazil, 41950-610Withdrawn
BrazilResearch Site Santa Catarina, Brazil, 88301-220Withdrawn
BrazilResearch Site Santo André, Brazil, 09060-650Withdrawn
BrazilResearch Site São José do Rio Preto, Brazil, 15025-100Completed
BrazilResearch Site São Paulo, Brazil, 01321-001Completed
BrazilResearch Site São Paulo, Brazil, 04039-031Withdrawn
PolandResearch Site Kraków, Poland, 31-202Completed
PolandResearch Site Łódź, Poland, 90-302Active, not recruiting
PolandResearch Site Otwock, Poland, 05-400Active, not recruiting
PolandResearch Site Poznan, Poland, 60-569Completed
PolandResearch Site Poznań, Poland, 60-569Active, not recruiting
PolandResearch Site Racibórz, Poland, 47-400Active, not recruiting
PolandResearch Site Warszawa, Poland, 02-781Active, not recruiting
PolandResearch Site Wieliszew, Poland, 05-135Active, not recruiting
FranceResearch Site Bron, France, 69677Active, not recruiting
FranceResearch Site Lille, France, 59000Active, not recruiting
FranceResearch Site Limoges, France, 87042Not Yet Recruiting
FranceResearch Site Lyon, France, 69008Active, not recruiting
FranceResearch Site PARIS, France, 75020Active, not recruiting
ItalyResearch Site Bari, Italy, 70124Active, not recruiting
ItalyResearch Site Bergamo, Italy, 24127Active, not recruiting
ItalyResearch Site Bologna, Italy, 40138Active, not recruiting
ItalyResearch Site Cremona, Italy, 26100Completed
ItalyResearch Site Firenze, Italy, 50134Active, not recruiting
ItalyResearch Site Livorno, Italy, 57124Withdrawn
ItalyResearch Site Lucca, Italy, 55100Completed
ItalyResearch Site Meldola, Italy, 47014Active, not recruiting
ItalyResearch Site Milano, Italy, 20132Completed
ItalyResearch Site Milano, Italy, 20162Completed
ItalyResearch Site MILANO, Italy, 20141Active, not recruiting
ItalyResearch Site NOVARA, Italy, 28100Active, not recruiting
ItalyResearch Site Orbassano, Italy, 10043Active, not recruiting
ItalyResearch Site PADOVA, Italy, 35128Active, not recruiting
ItalyResearch Site Palermo, Italy, 90127Withdrawn
ItalyResearch Site Parma, Italy, 43100Active, not recruiting
ItalyResearch Site Rimini, Italy, 47900Withdrawn
ItalyResearch Site Roma, Italy, 00152Completed
GermanyResearch Site Aachen, Germany, 52074Completed
GermanyResearch Site Berlin, Germany, 13125Active, not recruiting
GermanyResearch Site Berlin, Germany, 12351Active, not recruiting
GermanyResearch Site Berlin, Germany, 13359Active, not recruiting
GermanyResearch Site Coswig, Germany, 01640Terminated
GermanyResearch Site Gauting, Germany, 82131Terminated
GermanyResearch Site Gerlingen, Germany, 70839Active, not recruiting
GermanyResearch Site Großhansdorf, Germany, 22927Active, not recruiting
GermanyResearch Site Halle, Germany, 06120Active, not recruiting
GermanyResearch Site Hamburg, Germany, 20251Completed
GermanyResearch Site Homburg, Germany, 66421Terminated
GermanyResearch Site Immenhausen, Germany, 34376Active, not recruiting
GermanyResearch Site Kassel, Germany, 34125Completed
GermanyResearch Site Köln, Germany, 51109Active, not recruiting
GermanyResearch Site Lübeck, Germany, 23538Active, not recruiting
GermanyResearch Site München, Germany, 81925Withdrawn
GermanyResearch Site Trier, Germany, 54290Withdrawn
GermanyResearch Site Würzburg, Germany, 97074Active, not recruiting
TaiwanResearch Site Changhua, Taiwan, 50006Active, not recruiting
TaiwanResearch Site Kaohsiung, Taiwan, 83301Withdrawn
TaiwanResearch Site Putzu City, Taiwan, 0613Active, not recruiting
TaiwanResearch Site Taichung, Taiwan, 40705Active, not recruiting
TaiwanResearch Site Taichung City, Taiwan, 402Active, not recruiting
TaiwanResearch Site Tainan, Taiwan, 70403Active, not recruiting
TaiwanResearch Site Tainan City, Taiwan, 73657Active, not recruiting
TaiwanResearch Site Taipei, Taiwan, 112Active, not recruiting
TaiwanResearch Site Taipei, Taiwan, 10002Active, not recruiting
TaiwanResearch Site Taipei, Taiwan, 235Withdrawn
TaiwanResearch Site Tao-Yuan, Taiwan, 333Active, not recruiting
AustraliaResearch Site Bedford Park, Australia, 5042Active, not recruiting
AustraliaResearch Site Camperdown, Australia, 2050Active, not recruiting
AustraliaResearch Site Darlinghurst, Australia, 2010Active, not recruiting
AustraliaResearch Site Frankston, Australia, 3199Withdrawn
AustraliaResearch Site Heidelberg, Australia, 3084Active, not recruiting
AustraliaResearch Site Kogarah, Australia, 2217Active, not recruiting
AustraliaResearch Site Kurralta Park, Australia, 5037Active, not recruiting
AustraliaResearch Site Woolloongabba, Australia, 4102Active, not recruiting
BelgiumResearch Site Baudour, Belgium, 7331Withdrawn
BelgiumResearch Site Brussels, Belgium, 1090Active, not recruiting
BelgiumResearch Site Brussels, Belgium, 1200Suspended
BelgiumResearch Site Brussels, Belgium, 1070Withdrawn
BelgiumResearch Site Bruxelles, Belgium, 1000Withdrawn
BelgiumResearch Site Gent, Belgium, 9000Suspended
BelgiumResearch Site Kortrijk, Belgium, 8500Suspended
BelgiumResearch Site Ottignies, Belgium, 1340Suspended
RomaniaResearch Site Bucharest, Romania, 050098Completed
RomaniaResearch Site Bucuresti, Romania, 031422Completed
RomaniaResearch Site Cluj Napoca, Romania, 400015Active, not recruiting
RomaniaResearch Site Craiova, Romania, 200385Completed
RomaniaResearch Site Focsani, Romania, 620165Completed
RomaniaResearch Site Iasi, Romania, 700483Active, not recruiting
RomaniaResearch Site Timisoara, Romania, 300210Completed
Russian FederationResearch Site Arkhangelsk, Russian Federation, 163045Active, not recruiting
Russian FederationResearch Site Kazan, Russian Federation, 420029Active, not recruiting
Russian FederationResearch Site Moscow, Russian Federation, 115478Completed
Russian FederationResearch Site Moscow, Russian Federation, 115478Active, not recruiting
Russian FederationResearch Site MOSCOW, Russian Federation, 143423Active, not recruiting
Russian FederationResearch Site Obninsk, Russian Federation, 249036Active, not recruiting
Russian FederationResearch Site Omsk, Russian Federation, 644013Active, not recruiting
Russian FederationResearch Site Omsk, Russian Federation, 644013Active, not recruiting
Russian FederationResearch Site Pyatigorsk, Russian Federation, 357502Active, not recruiting
Russian FederationResearch Site Rostov-on-Don, Russian Federation, 344037Active, not recruiting
Russian FederationResearch Site Ryazan, Russian Federation, 390011Active, not recruiting
Russian FederationResearch Site Saint Petersburg, Russian Federation, 198255Active, not recruiting
Russian FederationResearch Site Saint Petersburg, Russian Federation, 194291Terminated
Russian FederationResearch Site Saint Petersburg, Russian Federation, 195271Active, not recruiting
Russian FederationResearch Site Saint-Petersburg, Russian Federation, 197758Active, not recruiting
Russian FederationResearch Site Sankt-Peterburg, Russian Federation, 197758Active, not recruiting
Russian FederationResearch Site St. Petersburg, Russian Federation, 197022Active, not recruiting
ThailandResearch Site Bangkok, Thailand, 10330Active, not recruiting
ThailandResearch Site Bangkok, Thailand, 10700Active, not recruiting
ThailandResearch Site Khon Kaen, Thailand, 40002Active, not recruiting
ThailandResearch Site Muang, Thailand, 57000Active, not recruiting
ThailandResearch Site Muang, Thailand, 50200Active, not recruiting
ThailandResearch Site Phitsanulok, Thailand, 65000Active, not recruiting
ThailandResearch Site Songkla, Thailand, 90110Active, not recruiting
South KoreaResearch Site Cheongju-si, South Korea, 28644Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 02841Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 135-710Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 05030Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 05505Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 156-707Active, not recruiting
South KoreaResearch Site Suwon, South Korea, 16499Active, not recruiting
South KoreaResearch Site Suwon-si, South Korea, 16247Active, not recruiting
NetherlandsResearch Site Amsterdam, Netherlands, 1081 HVTerminated
NetherlandsResearch Site ARNHEM, Netherlands, 6815 ADTerminated
NetherlandsResearch Site ASSEN, Netherlands, 9401 RKWithdrawn
NetherlandsResearch Site Eindhoven, Netherlands, 5623EJWithdrawn
NetherlandsResearch Site HOOFDDORP, Netherlands, 2134 TMTerminated
NetherlandsResearch Site Zwolle, Netherlands, 8025 ABTerminated
United States of America , UTResearch Site Salt Lake City, UT, United States of America, 84106Withdrawn
United States of America , HIResearch Site Honolulu, HI, United States of America, 96819Active, not recruiting
United States of America , VAResearch Site Fort Belvoir, VA, United States of America, 22060Active, not recruiting
United States of America , GAResearch Site Athens, GA, United States of America, 30607Completed
United States of America , CTResearch Site New Haven, CT, United States of America, 06520Active, not recruiting
United States of America , CTResearch Site Norwalk, CT, United States of America, 06856Completed
United States of America , MDResearch Site Bethesda, MD, United States of America, 20817Completed
VietnamResearch Site Ha Noi, Vietnam, 100000Active, not recruiting
VietnamResearch Site Hanoi City, Vietnam, 100000Active, not recruiting
VietnamResearch Site Ho Chi Minh, Vietnam, 700000Active, not recruiting
VietnamResearch Site Ho Chi Minh, Vietnam, 70000Active, not recruiting
United States of America , LAResearch Site Marrero, LA, United States of America, 70072Withdrawn
United States of America , ILResearch Site Chicago, IL, United States of America, 60612Active, not recruiting
United States of America , ILResearch Site Elk Grove Village, IL, United States of America, 60007Terminated
United States of America , RIResearch Site Pawtucket, RI, United States of America, 02860Completed
United States of America , NJResearch Site Brick, NJ, United States of America, 08724Completed
United States of America , NJResearch Site Florham Park, NJ, United States of America, 07932Active, not recruiting
Hong KongResearch Site Hong Kong, Hong Kong, Active, not recruiting
Hong KongResearch Site Hong Kong, Hong Kong, 150001Active, not recruiting
Hong KongResearch Site King's Park, Hong Kong, 150001Active, not recruiting
HungaryResearch Site Budapest, Hungary, 1083Completed
HungaryResearch Site Budapest, Hungary, 1121Completed
HungaryResearch Site Deszk, Hungary, 6772Active, not recruiting
HungaryResearch Site Székesfehérvár, Hungary, 8000Completed
HungaryResearch Site Törökbálint, Hungary, 2045Completed
TurkeyResearch Site Ankara, Turkey, 6500Completed
TurkeyResearch Site Ankara, Turkey, 06280Active, not recruiting
TurkeyResearch Site Bursa, Turkey, 16059Active, not recruiting
TurkeyResearch Site Diyarbakir, Turkey, 21280Withdrawn
TurkeyResearch Site Istanbul, Turkey, 34093Active, not recruiting
TurkeyResearch Site Istanbul, Turkey, 34098Active, not recruiting
TurkeyResearch Site Istanbul, Turkey, 34722Active, not recruiting
TurkeyResearch Site Istanbul, Turkey, 34069Active, not recruiting
TurkeyResearch Site Izmir, Turkey, 35575Withdrawn
TurkeyResearch Site Izmir, Turkey, 35100Completed
IsraelResearch Site Beer-Sheva, Israel, 8410101Completed
IsraelResearch Site Haifa, Israel, 31999Active, not recruiting
IsraelResearch Site Jerusalem, Israel, 91120Active, not recruiting
IsraelResearch Site Kfar-Saba, Israel, 4428164Active, not recruiting
IsraelResearch Site Petah Tikva, Israel, 4941492Active, not recruiting
IsraelResearch Site Tel Aviv, Israel, 6423906Completed
IsraelResearch Site Tel Hashomer, Israel, 52621Active, not recruiting
NorwayResearch Site Oslo, Norway, N-0379Withdrawn
SwedenResearch Site LINKÖPING, Sweden, 581 85Active, not recruiting
United States of America , TNResearch Site Chattanooga, TN, United States of America, 37404Completed
United States of America , TNResearch Site Nashville, TN, United States of America, 37203Completed
United States of America , FLResearch Site Ft Myers, FL, United States of America, 33901Completed
United States of America , FLResearch Site Pembroke Pines, FL, United States of America, 33028Completed
United States of America , FLResearch Site St Petersburg, FL, United States of America, 33705Active, not recruiting
ChinaResearch Site Beijing, China, 100210Active, not recruiting
ChinaResearch Site Beijing, China, 100029Active, not recruiting
ChinaResearch Site Changchun, China, 130021Active, not recruiting
ChinaResearch Site Changchun, China, 130012Active, not recruiting
ChinaResearch Site Chongqing, China, 400038Withdrawn
ChinaResearch Site Dalian, China, 116027Active, not recruiting
ChinaResearch Site Fuzhou, China, 350025Withdrawn
ChinaResearch Site Guangzhou, China, 510180Active, not recruiting
ChinaResearch Site Guangzhou, China, 510060Active, not recruiting
ChinaResearch Site Hangzhou, China, 310009Active, not recruiting
ChinaResearch Site Kunming, China, 650118Active, not recruiting
ChinaResearch Site Nanjing, China, 210029Active, not recruiting
ChinaResearch Site Nanning, China, 530021Active, not recruiting
ChinaResearch Site Shanghai, China, 200032Active, not recruiting
ChinaResearch Site Suzhou, China, 215006Withdrawn
ChinaResearch Site Suzhou, China, 215006Active, not recruiting
ChinaResearch Site Tianjin, China, 300060Active, not recruiting
ChinaResearch Site Tianjin, China, 300051Completed
ChinaResearch Site xi'an, China, 710038Withdrawn
ChinaResearch Site Xian, China, 710061Active, not recruiting
ChinaResearch Site Yangzhou, China, 225001Active, not recruiting
ChinaResearch Site Zhengzhou, China, 450008Active, not recruiting
United States of America , COResearch Site Grand Junction, CO, United States of America, 81501Active, not recruiting
UkraineResearch Site Dnipro, Ukraine, 49102Completed
UkraineResearch Site Kyiv, Ukraine, 03115Withdrawn
UkraineResearch Site Lviv, Ukraine, 79031Completed
UkraineResearch Site Sumy, Ukraine, 40022Completed
UkraineResearch Site Uzhhorod, Ukraine, 88000Active, not recruiting
UkraineResearch Site Vinnytsia, Ukraine, 21029Completed
UkraineResearch Site Zaporizhzhia, Ukraine, 69040Active, not recruiting
United States of America , TXResearch Site San Antonio, TX, United States of America, 78229Completed
United States of America , NYResearch Site Mineola, NY, United States of America, 11501Completed

Oversight


Is FDA regulated intervention: Yes 
Is IND/IDE protocol: Yes 
Section 801 trial: Yes 
Delayed Posting: No 
IND/IDE Grantor: CDER 
IND/IDE Number: 117879 
Has Expanded Access: No 

More Information


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

No publications provided

Responsible Party:AstraZeneca
ClinicalTrials.gov Identifier:NCT02511106
Other Study ID Numbers:D5164C00001, 2015-000662-65
Health Authority:United States: Food and Drug Administration
United States: Institutional Review Board
Australia:Therapeutic Goods Administration
Brazil: ANVISA
Belgium: Federal Agency for Medicines and Health Products
Canada: Agency for Drugs and Technologies in Health
China: State Food and Drug Administration
France: National Agency for the Safety of Medicine and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Hungary:National Institute of Pharmacy
Hong Kong: Hong Kong Drug Registration & Import/Export Control Division
Italy: Italian Medicines Agency
Israel: Ministry of Health Israel
Korea: Ministry of Food and drug Safety
Japan: Pharmaceuticals Medical Devices Agency
Netherlands:Medicines Evaluation Board
Norway: The Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Spain: Spanish Agency for Medicines and Health Products
Sweden: Medical Products Agency (Lakemedelsverket)
Taiwan: Food and Drug Administration
Thailand: Food and Drug Administration
Russia: Federal Drug Control Service
Turkey: Ministry of Health
Vietnam: Drug Administration of Vietnam
Ukraine: Ministry of Health; State Administration on Medicinal and Medical Use Products

Keywords provided by AstraZeneca
Stage IB-IIA-IIIA Non-Small Cell Lung Cancer; EGFRm+; Ex19Del; L858R; AZD9291; Phase III, adjuvant chemotherapy; complete tumour resection; EGFR-TKI

Additional Relevant MeSH terms:
Stage IB-IIIA non-small cell lung carcinoma

Primary Outcome Measures:

  • 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). Estimated median time to event of 46 and 66 months for those on placebo and AZD9291, respectively. ] [ Designated as safety issue: No ]
    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)

Secondary Outcome Measures:

  • 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). Estimated median time to event of 46 and 66 months for those on placebo and AZD9291, respectively. ] [ Designated as safety issue: No ]
    Defined as the proportion 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

  • Overall Survival (OS) [ Time Frame: From date of randomization until date of death due to any cause (estimated median 96 months for those on placebo) ] [ Designated as safety issue: No ]
    Defined as the time from the date of randomization until date of death due to any cause

  • Overall Survival rate at 5 years [ Time Frame: From date of randomization until date of death due to any cause (estimated median 96 months for those on placebo) ] [ Designated as safety issue: No ]
    Defined as the proportion of patients alive at 5 years, estimated from a Kaplan Meier plot of OS at the time of the primary analysis

  • Patient health-related quality of life and symptoms (HRQoL) by SF-36v2 Health Survey [ Time Frame: From date of randomization until treatment completion or discontinuation (max. 36 months) ] [ Designated as safety issue: No ]
    Measured by SF-36 Questionnaire consisting in 36 items that is an instrument for assessing a person’s general health status over the past 28 days. The scores for each of the 8 health domain scores and for each of the physical and mental component summary measures from the SF-36 v2 will be summarized in terms of mean changes from baseline at each post-baseline assessment.

  • Plasma concentrations of AZD9291 [ Time Frame: From date of dosing to month 24 (approximately 24 months) ] [ Designated as safety issue: No ]
    The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291

  • Plasma concentrations of AZ5104 and AZ7550 metabolites and ratio of metabolite to AZD9291 [ Time Frame: From date of dosing to month 24 (approximately 24 months) ] [ Designated as safety issue: No ]
    The pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 and AZ7550 metabolites

Other Pre-specified Outcome Measures:

  • Incidence of Adverse Events (AEs) [ Time Frame: From date of randomization until 28 days after treatment completion (max. 37 months) ] [ Designated as safety issue: Yes ]
    AEs graded by CTCAE version 4.0

ArmsAssigned Interventions
Experimental: AZD9291
AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
Drug: AZD9291 80 mg/40 mg
The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.
Other Name: Not applicable
 
Placebo Comparator: Placebo AZD9291
Matching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
Drug: Placebo AZD9291 80 mg/40 mg
The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.
Other Name: Not applicable