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

ClinicalTrials.gov ID NCT02511106
Sponsor AstraZeneca
Information provided by AstraZeneca (Responsible Party)
Last Update Posted 2024-12-05
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Study Overview

Brief Summary
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
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.
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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).
Conditions
Stage IB-IIIA Non-small Cell Lung Carcinoma
Intervention / Treatment
  • Drug: AZD9291 80 mg/40 mg
  • Drug: Placebo AZD9291 80 mg/40 mg
  • Drug: Open-label AZD9291 80 mg/40 mg
  • Drug: AZD9291 80 mg/40 mg
  • Drug: Placebo AZD9291 80 mg/40 mg
  • Drug: Open-label AZD9291 80 mg/40 mg
Other Study ID Numbers
  • D5164C00001
  • 2023-506524-82-00 ( Registry Identifier ) (REGISTRY: CTIS)
    2023-506524-82-00 ( Registry Identifier ) (REGISTRY: CTIS)
  • 2015-000662-65 ( EudraCT Number )
    2015-000662-65 ( EudraCT Number )
Study Start (Actual)
2015-10-21
Primary Completion (Actual)
2022-04-11
Study Completion (Estimated)
2029-01-31
Enrollment (Actual)
682
Study Type
Interventional
Phase
Phase 3

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 241 locations
United States
California Locations
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 Locations
Grand Junction, Colorado, United States, 81501

Research Site
Connecticut Locations
New Haven, Connecticut, United States, 06520

Research Site
Norwalk, Connecticut, United States, 06856

Research Site
Florida Locations
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 Locations
Athens, Georgia, United States, 30607

Research Site
Hawaii Locations
Honolulu, Hawaii, United States, 96819

Research Site
Illinois Locations
Chicago, Illinois, United States, 60612

Research Site
Elk Grove Village, Illinois, United States, 60007

Research Site
Maryland Locations
Bethesda, Maryland, United States, 20817

Research Site
New Jersey Locations
Brick, New Jersey, United States, 08724

Research Site
Florham Park, New Jersey, United States, 07932

Research Site
New York Locations
Mineola, New York, United States, 11501

Research Site
Rhode Island Locations
Pawtucket, Rhode Island, United States, 02860

Research Site
Tennessee Locations
Chattanooga, Tennessee, United States, 37404

Research Site
Nashville, Tennessee, United States, 37203

Research Site
Texas Locations
San Antonio, Texas, United States, 78229

Research Site
Virginia Locations
Fort Belvoir, Virginia, United States, 22060

Research Site
Australia
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
Belgium
Brussels, Belgium, 1090

Research Site
Brussel, Belgium, 1200

Research Site
Gent, Belgium, 9000

Research Site
Kortrijk, Belgium, 8500

Research Site
Brazil
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
Canada
Ontario Locations
Toronto, Ontario, Canada, M5G 2M9

Research Site
China
Beijing, China, 100029

Research Site
Beijing, China, 100142

Research Site
Beijing, China, 100210

Research Site
Beijing, China, 100730

Research Site
Changchun, China, 130012

Research Site
Changchun, China, 130021

Research Site
Dalian, China, 116027

Research Site
Guangzhou, China, 510060

Research Site
Guangzhou, China, 510120

Research Site
Guangzhou, China, 510180

Research Site
Hangzhou, China, 310003

Research Site
Hangzhou, China, 310009

Research Site
Hangzhou, China, 310022

Research Site
Kunming, China, 650118

Research Site
Nanjing, China, 210029

Research Site
Nanning, China, 530021

Research Site
Shanghai, China, 200030

Research Site
Shanghai, China, 200032

Research Site
Shanghai, China, 200072

Research Site
Shenyang, China, 110001

Research Site
Suzhou, China, 215006

Research Site
Tianjin, China, 300051

Research Site
Tianjin, China, 300052

Research Site
Tianjin, China, 300060

Research Site
Urumqi, China, 830000

Research Site
Xi'an, China, 710061

Research Site
Xiamen, China, 361004

Research Site
Yangzhou, China, 225001

Research Site
Zhengzhou, China, 450008

Research Site
Ürümqi, China, 830000

Research Site
France
Bron, France, 69677

Research Site
Lille, France, 59000

Research Site
Limoges Cedex, France, 87042

Research Site
Lyon, France, 69008

Research Site
Paris, France, 75020

Research Site
Germany
Aachen, Germany, 52074

Research Site
Berlin, Germany, 12351

Research Site
Berlin, Germany, 13125

Research Site
Berlin, Germany, 13359

Research Site
Coswig, Germany, 01640

Research Site
Gauting, Germany, 82131

Research Site
Gerlingen, Germany, 70839

Research Site
Grosshansdorf, Germany, 22927

Research Site
Halle, Germany, 06120

Research Site
Hamburg, Germany, 20251

Research Site
Homburg, Germany, 66421

Research Site
Immenhausen, Germany, 34376

Research Site
Kassel, Germany, 34125

Research Site
Köln, Germany, 51109

Research Site
Lübeck, Germany, 23538

Research Site
Würzburg, Germany, 97074

Research Site
Hong Kong
Hong Kong, Hong Kong, 150001

Research Site
Hong Kong, Hong Kong

Research Site
King's Park, Hong Kong, 150001

Research Site
Hungary
Budapest, Hungary, 1083

Research Site
Budapest, Hungary, 1121

Research Site
Deszk, Hungary, 6772

Research Site
Székesfehérvár, Hungary, 8000

Research Site
Törökbálint, Hungary, 2045

Research Site
Israel
Beer-Sheva, Israel, 8410101

Research Site
Haifa, Israel, 31999

Research Site
Jerusalem, Israel, 91120

Research Site
Kfar-Saba, Israel, 4428164

Research Site
Petah Tikva, Israel, 4941492

Research Site
Ramat Gan, Israel, 5262000

Research Site
Tel Aviv, Israel, 6423906

Research Site
Italy
Bari, Italy, 70124

Research Site
Bergamo, Italy, 24127

Research Site
Bologna, Italy, 40138

Research Site
Cremona, Italy, 26100

Research Site
Firenze, Italy, 50134

Research Site
Lucca, Italy, 55100

Research Site
Meldola, Italy, 47014

Research Site
Milano, Italy, 20132

Research Site
Milano, Italy, 20141

Research Site
Milano, Italy, 20162

Research Site
Novara, Italy, 28100

Research Site
Orbassano, Italy, 10043

Research Site
Padova, Italy, 35128

Research Site
Parma, Italy, 43126

Research Site
Roma, Italy, 00152

Research Site
Japan
Bunkyo-ku, Japan, 113-8431

Research Site
Fukuoka, Japan, 812-8582

Research Site
Hirakata-shi, Japan, 573-1191

Research Site
Hiroshima-shi, Japan, 730-8518

Research Site
Hiroshima-shi, Japan, 734-8551

Research Site
Kanazawa, Japan, 920-8641

Research Site
Kashiwa, Japan, 277-8577

Research Site
Kitakyushu-shi, Japan, 807-8555

Research Site
Kobe-shi, Japan, 650-0047

Research Site
Kurume-shi, Japan, 830-0011

Research Site
Matsuyama-shi, Japan, 791-0280

Research Site
Nagoya-shi, Japan, 453-8511

Research Site
Niigata-shi, Japan, 951-8566

Research Site
Osakasayama-shi, Japan, 589-8511

Research Site
Sagamihara-shi, Japan, 252-0375

Research Site
Sakai-shi, Japan, 591-8555

Research Site
Sasebo-shi, Japan, 857-8511

Research Site
Sendai-shi, Japan, 980-0873

Research Site
Shinjuku-ku, Japan, 160-0023

Research Site
Sunto-gun, Japan, 411-8777

Research Site
Ube-shi, Japan, 755-0241

Research Site
Yokohama-shi, Japan, 240-8555

Research Site
Yokohama-shi, Japan, 241-8515

Research Site
Yonago-shi, Japan, 683-8504

Research Site
Korea, Republic of
Cheongju-si, Korea, Republic of, 28644

Research Site
Seoul, Korea, Republic of, 02841

Research Site
Seoul, Korea, Republic of, 05030

Research Site
Seoul, Korea, Republic of, 138-736

Research Site
Seoul, Korea, Republic of, 156-707

Research Site
Seoul, Korea, Republic of, 6351

Research Site
Suwon, Korea, Republic of, 16247

Research Site
Suwon, Korea, Republic of, 16499

Research Site
Netherlands
Amsterdam, Netherlands, 1081 HV

Research Site
Arnhem, Netherlands, 6815 AD

Research Site
Hoofddorp, Netherlands, 2134 TM

Research Site
Zwolle, Netherlands, 8025 AB

Research Site
Poland
Kraków, Poland, 31-202

Research Site
Otwock, Poland, 05-400

Research Site
Poznan, Poland, 60-569

Research Site
Poznań, Poland, 60-569

Research Site
Racibórz, Poland, 47-400

Research Site
Warszawa, Poland, 02-781

Research Site
Wieliszew, Poland, 05-135

Research Site
Łódź, Poland, 90-302

Research Site
Romania
Bucharest, Romania, 050098

Research Site
Bucuresti, Romania, 031422

Research Site
Cluj Napoca, Romania, 400015

Research Site
Craiova, Romania, 200385

Research Site
Focsani, Romania, 620165

Research Site
Iasi, Romania, 700483

Research Site
Timisoara, Romania, 300210

Research Site
Russian Federation
Arkhangelsk, Russian Federation, 163045

Research Site
Kazan, Russian Federation, 420029

Research Site
Moscow, Russian Federation, 115478

Research Site
Moscow, Russian Federation, 143423

Research Site
Obninsk, Russian Federation, 249036

Research Site
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, 194291

Research Site
Saint Petersburg, Russian Federation, 195271

Research Site
Saint Petersburg, Russian Federation, 198255

Research Site
Saint-Petersburg, Russian Federation, 197758

Research Site
Sankt-Peterburg, Russian Federation, 197758

Research Site
St. Petersburg, Russian Federation, 197022

Research Site
Spain
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, 08035

Research Site
Madrid, Spain, 28007

Research Site
Madrid, Spain, 28040

Research Site
Madrid, Spain, 28046

Research Site
Majadahonda, Spain, 28222

Research Site
Málaga, Spain, 29010

Research Site
San Sebastian, Spain, 20014

Research Site
Valencia, Spain, 46010

Research Site
Valencia, Spain, 46026

Research Site
Zaragoza, Spain, 50009

Research Site
Sweden
Linköping, Sweden, 581 85

Research Site
Taiwan
Changhua, Taiwan, 50006

Research Site
Putzu City, Taiwan, 0613

Research Site
Taichung City, Taiwan, 402

Research Site
Taichung, Taiwan, 40705

Research Site
Tainan City, Taiwan, 73657

Research Site
Tainan, Taiwan, 70403

Research Site
Taipei, Taiwan, 10002

Research Site
Taipei, Taiwan, 112

Research Site
Tao-Yuan, Taiwan, 333

Research Site
Thailand
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
Turkey
Ankara, Turkey, 06280

Research Site
Ankara, Turkey, 6500

Research Site
Bursa, Turkey, 16059

Research Site
Istanbul, Turkey, 34069

Research Site
Istanbul, Turkey, 34093

Research Site
Istanbul, Turkey, 34098

Research Site
Istanbul, Turkey, 34722

Research Site
Izmir, Turkey, 35100

Research Site
Ukraine
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
Vietnam
Hanoi, Vietnam, 100000

Research Site
Hanoi, Vietnam, 10000

Research Site
Ho Chi Minh, Vietnam, 70000

Research Site
Click to view interactive map

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.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
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.
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Ages Eligible for Study
18 Years to 130 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

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

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : Triple (ParticipantInvestigatorOutcomes Assessor)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: AZD9291
AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
Intervention/Treatment Drug: AZD9291 80 mg/40 mg
  • The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.

Drug: Open-label AZD9291 80 mg/40 mg
  • Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.

Participant Group/Arm Placebo Comparator: Placebo AZD9291
Matching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.
Intervention/Treatment 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.

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).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).Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Disease Free Survival (DFS) Rate at 2, 3 and 5 YearsDefined 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.Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months). DFS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.
Overall Survival (OS)Defined as the time from the date of randomization until date of death due to any cause.Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months)
Overall Survival Rate at 2, 3 and 5 YearsDefined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS.Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months). OS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.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 3 years.
Plasma Concentrations of AZD9291The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)
Plasma Concentrations of AZ5104 MetabolitesThe pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 metabolitesFrom date of dosing to week 96 (approximately 24 months)
Plasma Concentrations of AZ7550 MetabolitesThe pharmacokinetics exposure parameters derived from plasma concentrations of AZ7550 metabolitesFrom 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
AstraZeneca

Publications

Study Results

These publications are provided voluntarily by the person who enters information about the study and are about the study results.

From PubMed

These publications come from PubMed, a public database of scientific and medical articles. This list is automatically created by ClinicalTrials.gov Identifier (NCT Number), and these articles may or may not be about the study.

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 Registration Dates
First Submitted
2015-07-28
First Submitted that Met QC Criteria
2015-07-28
First Posted (Estimated)
2015-07-29
Results Reporting Dates
Results First Submitted
2021-01-15
Results First Submitted that Met QC Criteria
2021-07-06
Results First Posted
2021-07-27
Study Record Updates
Last Update Submitted that met QC Criteria
2024-12-04
Last Update Posted
2024-12-05
Last Verified
2024-12

More Information

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Keywords Provided by AstraZeneca
Additional Relevant MeSH Terms

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 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 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 Supporting Information Type
Study Protocol
Statistical Analysis Plan (SAP)
IPD Sharing Url
https://astrazenecagroup-dt.pharmacm.com/DT/Home(https://astrazenecagroup-dt.pharmacm.com/DT/Home)