AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
FLAURA
A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.
3 other identifiers
interventional
674
30 countries
170
Brief Summary
To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2014
Longer than P75 for phase_3
170 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedStudy Start
First participant enrolled
December 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2017
CompletedResults Posted
Study results publicly available
November 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2025
CompletedApril 21, 2026
April 1, 2026
2.5 years
October 22, 2014
June 13, 2018
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Median Progression Free Survival (PFS) (Months)
Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS. The primary endpoint of PFS was based on Investigator assessment.
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months
Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS.
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
Secondary Outcomes (11)
Objective Response Rate (ORR)
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression
Duration of Response (DoR)
At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression
Disease Control Rate (DCR)
At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression
Depth of Response
At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression
Overall Survival (OS)- Number of Participants With an Event
From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks (approximately 29 months)
- +6 more secondary outcomes
Study Arms (2)
AZD9291+ placebo
EXPERIMENTALAZD9291 (80 mg or 40 mg orally, once daily) plus placebo Erlotinib (150mg or 100mg orally, once daily) or placebo Gefitinib (250 mg orally, once daily), in accordance with the randomization schedule.
Standard of Care + placebo AZD9291
ACTIVE COMPARATORErlotinib (150 mg or 100 mg orally, once daily) or placebo Gefitinib (250 mg orally, once daily) plus placebo AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomisation schedule. Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291).
Interventions
The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
The initial dose of Placebo Erlotinib 150 mg once daily can be reduced to Placebo 100 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
The initial dose of Placebo Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
The initial dose of Erlotinib 150mg once daily can be reduced to 10 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291).
The initial dose of Gefitinib 250mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291).
The initial dose of Placebo AZD9291 80 mg once daily can be reduced to Placebo AZD9291 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
Eligibility Criteria
You may qualify if:
- Male or female, aged at least 18 years.
- Pathologically confirmed adenocarcinoma of the lung.
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
- The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).
- Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status.
- Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre. Prior adjuvant and neo-adjuvant therapy is permitted(chemotherapy, radiotherapy, investigational agents).
- Provision of informed consent prior to any study specific procedures, sampling, and analysis.
- World Health Organization Performance Status of 0 to 1 with no clinically significant deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
You may not qualify if:
- Treatment with any of the following:
- Prior treatment with any systemic anti-cancer therapy for locally advanced/metastatic NSCLC.
- Prior treatment with an EGFR-TKI.
- Major surgery within 4 weeks of the first dose of study drug.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation 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.
- Alternative anti-cancer treatment
- Treatment with an investigational drug within five half-lives of the compound or any of its related material.
- Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug.
- Spinal cord compression, symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) \>470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTcF value.
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (170)
Research Site
Anaheim, California, 92801, United States
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Santa Rosa, California, 95403, United States
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West Hills, California, 91307, United States
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Tampa, Florida, 33612, United States
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Atlanta, Georgia, 30318, United States
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Atlanta, Georgia, 30322, United States
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Marietta, Georgia, 30060, United States
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Louisville, Kentucky, 40202, United States
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Bethesda, Maryland, 20817, United States
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Boston, Massachusetts, 02215, United States
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Minneapolis, Minnesota, 55407, United States
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Lebanon, New Hampshire, 03756, United States
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Salisbury, North Carolina, 28144, United States
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Burlington, Vermont, 05401, United States
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Camperdown, 2050, Australia
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Chermside, 4032, Australia
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Clayton, 3168, Australia
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Heidelberg, 3084, Australia
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Kogarah, 2217, Australia
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Nedlands, 6009, Australia
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Woolloongabba, 4102, Australia
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Roeselare, 8800, Belgium
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Porto Alegre, 90610-000, Brazil
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Sofia, 1330, Bulgaria
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Edmonton, Alberta, T6G 1Z2, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Beijing, 100071, China
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Beijing, 100853, China
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Changchun, 130012, China
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Changchun, 130021, China
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Chongqing, 400037, China
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Chongqing, 400038, China
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Chongqing, 400042, China
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Fuzhou, 350025, China
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Guangzhou, 510080, China
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Hangzhou, 310022, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Shanghai, 200433, China
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Shenyang, 110001, China
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Suzhou, 215006, China
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Ürümqi, 830000, China
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Wuhan, 430071, China
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Xi'an, 710038, China
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Xi'an, 710061, China
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Yangzhou, 225001, China
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Ostrava, 708 52, Czechia
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Caen, F-14033, France
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Créteil, 94010, France
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Lyon, 69373, France
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Nantes, 44202, France
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Toulon Naval, 83800, France
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Villejuif, 94805, France
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Bad Berka, 99437, Germany
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Berlin, 13125, Germany
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Gauting, 82131, Germany
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Halle, 06120, Germany
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Heidelberg, 69126, Germany
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Karlsruhe, 76137, Germany
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Lübeck, 23538, Germany
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München, 81925, Germany
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Villingen-Schwenningen, 78052, Germany
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Farkasgyepü, 8582, Hungary
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Gyöngyös - Mátraháza, 3200, Hungary
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Miskolc, 3529, Hungary
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Székesfehérvár, 8000, Hungary
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Tatabánya, 2800, Hungary
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Zalaegerszeg, 8900, Hungary
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Haifa, 31999, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 49100, Israel
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Tel Litwinsky, 52621, Israel
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Cremona, 26100, Italy
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Lecce, 73100, Italy
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Lecco, 23900, Italy
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Orbassano, 10043, Italy
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Parma, 43126, Italy
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Roma, 00144, Italy
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Sondrio, 23100, Italy
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Terni, 05100, Italy
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Hirakata-shi, 573-1191, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa, 277-8577, Japan
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Kobe, 650-0047, Japan
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Matsuyama, 791-0280, Japan
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Natori-shi, 981-1293, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Sagamihara-shi, 252-0375, Japan
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Sakaishi, 591-8555, Japan
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Sendai, 980-0873, Japan
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Sunto-gun, 411-8777, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 236-0051, Japan
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Yokohama, 240-8555, Japan
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Yokohama, 241-8515, Japan
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Kuala Lumpur, 59100, Malaysia
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Kuantan, 25100, Malaysia
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Kuching, 93586, Malaysia
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Cebu, 6000, Philippines
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Manila, 1000, Philippines
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Quezon City, 1100, Philippines
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Brzozoów, 36-200, Poland
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Otwock, 05-400, Poland
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Poznan, 60-569, Poland
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Szczecin, 70-891, Poland
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Warsaw, 02-781, Poland
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Amadora, 2720-276, Portugal
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Lisbon, 1769-001, Portugal
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Porto, 4200-072, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
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Bucharest, 022328, Romania
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Bucharest, 050098, Romania
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Craiova, 200347, Romania
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, 198255, Russia
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Cheongju-si, 28644, South Korea
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Incheon, 405-760, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02841, South Korea
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Seoul, 03722, South Korea
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Seoul, 06591, South Korea
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Seoul, 5030, South Korea
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A Coruña, 15006, Spain
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Barcelona, 08041, Spain
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Barcelona, 08221, Spain
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Barcelona, 08907, Spain
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Lleida, 25198, Spain
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Lugo, 27003, Spain
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Madrid, 28040, Spain
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Málaga, 29010, Spain
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Seville, 41014, Spain
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Zaragoza, 50009, Spain
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Linköping, 581 85, Sweden
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Lucerne, 6000, Switzerland
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Winterthur, 8401, Switzerland
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Zurich, 8091, Switzerland
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Kaohsiung City, 833, Taiwan
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Taichung, 402, Taiwan
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Tainan, 704, Taiwan
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Tainan, 73657, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Muang, 50200, Thailand
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Ankara, 6500, Turkey (Türkiye)
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Istanbul, 34069, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Dnipro, 49102, Ukraine
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Kryvyi Rih, 50048, Ukraine
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Lviv, 79031, Ukraine
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Sumy, 40022, Ukraine
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Edinburgh, EH4 2XU, United Kingdom
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London, NW1 2BU, United Kingdom
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Maidstone, ME16 9QQ, United Kingdom
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Withington, M20 4BX, United Kingdom
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
Related Publications (13)
Markovets A, Merino Vega D, Abbosh C, Quinn K, Chang K, Wienke S, Hartmaier R, Barrett JC, Hodgson D. Variability of Circulating Tumor DNA Levels in Plasma Samples From Patients With Advanced Non-Small-Cell Lung Cancer in the Absence of Treatment. JCO Precis Oncol. 2025 Oct;9:e2500287. doi: 10.1200/PO-25-00287. Epub 2025 Oct 30.
PMID: 41166679DERIVEDMurat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18.
PMID: 40311309DERIVEDViray H, Piper-Vallillo AJ, Widick P, Academia E, Shea M, Rangachari D, VanderLaan PA, Kobayashi SS, Costa DB. A Real-World Study of Patient Characteristics and Clinical Outcomes in EGFR Mutated Lung Cancer Treated with First-Line Osimertinib: Expanding the FLAURA Trial Results into Routine Clinical Practice. Cancers (Basel). 2024 Mar 7;16(6):1079. doi: 10.3390/cancers16061079.
PMID: 38539415DERIVEDJohnson M, Serra Traynor C, Vishwanathan K, Overend P, Hartmaier R, Markovets A, Chmielecki J, Mugundu GM, Barrett JC, Tomkinson H, Ramalingam SS. Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First-Line Mutant Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer. Clin Pharmacol Ther. 2024 Feb;115(2):349-360. doi: 10.1002/cpt.3113. Epub 2023 Dec 21.
PMID: 38010260DERIVEDWalding A, Skaltsa K, Casamayor M, Ryden A. Time to deterioration of patient-reported outcomes in non-small cell lung cancer: exploring different definitions. Qual Life Res. 2022 Aug;31(8):2535-2543. doi: 10.1007/s11136-022-03088-0. Epub 2022 Jan 31.
PMID: 35099678DERIVEDCheng Y, He Y, Li W, Zhang HL, Zhou Q, Wang B, Liu C, Walding A, Saggese M, Huang X, Fan M, Wang J, Ramalingam SS. Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. Target Oncol. 2021 Mar;16(2):165-176. doi: 10.1007/s11523-021-00794-6. Epub 2021 Feb 5.
PMID: 33544337DERIVEDLeighl NB, Karaseva N, Nakagawa K, Cho BC, Gray JE, Hovey T, Walding A, Ryden A, Novello S. Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer. Eur J Cancer. 2020 Jan;125:49-57. doi: 10.1016/j.ejca.2019.11.006. Epub 2019 Dec 12.
PMID: 31838405DERIVEDRamalingam SS, Vansteenkiste J, Planchard D, Cho BC, Gray JE, Ohe Y, Zhou C, Reungwetwattana T, Cheng Y, Chewaskulyong B, Shah R, Cobo M, Lee KH, Cheema P, Tiseo M, John T, Lin MC, Imamura F, Kurata T, Todd A, Hodge R, Saggese M, Rukazenkov Y, Soria JC; FLAURA Investigators. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020 Jan 2;382(1):41-50. doi: 10.1056/NEJMoa1913662. Epub 2019 Nov 21.
PMID: 31751012DERIVEDBrown H, Vansteenkiste J, Nakagawa K, Cobo M, John T, Barker C, Kohlmann A, Todd A, Saggese M, Chmielecki J, Markovets A, Scott M, Ramalingam SS. Programmed Cell Death Ligand 1 Expression in Untreated EGFR Mutated Advanced NSCLC and Response to Osimertinib Versus Comparator in FLAURA. J Thorac Oncol. 2020 Jan;15(1):138-143. doi: 10.1016/j.jtho.2019.09.009. Epub 2019 Oct 9.
PMID: 31605792DERIVEDGray JE, Okamoto I, Sriuranpong V, Vansteenkiste J, Imamura F, Lee JS, Pang YK, Cobo M, Kasahara K, Cheng Y, Nogami N, Cho EK, Su WC, Zhang G, Huang X, Li-Sucholeiki X, Lentrichia B, Dearden S, Jenkins S, Saggese M, Rukazenkov Y, Ramalingam SS. Tissue and Plasma EGFR Mutation Analysis in the FLAURA Trial: Osimertinib versus Comparator EGFR Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Nov 15;25(22):6644-6652. doi: 10.1158/1078-0432.CCR-19-1126. Epub 2019 Aug 22.
PMID: 31439584DERIVEDPlanchard D, Boyer MJ, Lee JS, Dechaphunkul A, Cheema PK, Takahashi T, Gray JE, Tiseo M, Ramalingam SS, Todd A, McKeown A, Rukazenkov Y, Ohe Y. Postprogression Outcomes for Osimertinib versus Standard-of-Care EGFR-TKI in Patients with Previously Untreated EGFR-mutated Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Apr 1;25(7):2058-2063. doi: 10.1158/1078-0432.CCR-18-3325. Epub 2019 Jan 18.
PMID: 30659024DERIVEDOhe Y, Imamura F, Nogami N, Okamoto I, Kurata T, Kato T, Sugawara S, Ramalingam SS, Uchida H, Hodge R, Vowler SL, Walding A, Nakagawa K. Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA Japanese subset. Jpn J Clin Oncol. 2019 Jan 1;49(1):29-36. doi: 10.1093/jjco/hyy179.
PMID: 30508196DERIVEDSoria JC, Ohe Y, Vansteenkiste J, Reungwetwattana T, Chewaskulyong B, Lee KH, Dechaphunkul A, Imamura F, Nogami N, Kurata T, Okamoto I, Zhou C, Cho BC, Cheng Y, Cho EK, Voon PJ, Planchard D, Su WC, Gray JE, Lee SM, Hodge R, Marotti M, Rukazenkov Y, Ramalingam SS; FLAURA Investigators. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Jan 11;378(2):113-125. doi: 10.1056/NEJMoa1713137. Epub 2017 Nov 18.
PMID: 29151359DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There were 19 Chinese participants who were included in both the global and China cohort which gives a total of 692 participants instead of a total of 673 participants.
Results Point of Contact
- Title
- Global Clinical Leader
- Organization
- AstraZeneca AB
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2014
First Posted
November 20, 2014
Study Start
December 3, 2014
Primary Completion
June 19, 2017
Study Completion
November 20, 2025
Last Updated
April 21, 2026
Results First Posted
November 6, 2018
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified 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.
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.