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AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Sponsor: AstraZeneca
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
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
674
Start Date
2014-12-03
Completion Date
2025-11-20
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
AZD9291 80 mg/40 mg + placebo
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.
Placebo Erlotinib 150/100mg
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.
Placebo Gefitinib 250 mg
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.
Erlotinib 150/100 mg
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).
Gefitinib 250 mg
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).
Placebo AZD9291 80 mg/ 40 mg
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.
Locations (170)
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Anaheim, California, United States
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Santa Rosa, California, United States
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West Hills, California, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Louisville, Kentucky, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Lebanon, New Hampshire, United States
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Salisbury, North Carolina, United States
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Burlington, Vermont, United States
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Camperdown, Australia
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Chermside, Australia
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Clayton, Australia
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Heidelberg, Australia
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Kogarah, Australia
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Nedlands, Australia
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Woolloongabba, Australia
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Porto Alegre, Brazil
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Sofia, Bulgaria
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Edmonton, Alberta, Canada
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Beijing, China
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Beijing, China
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Changchun, China
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Changchun, China
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Chongqing, China
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Chongqing, China
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Chongqing, China
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Fuzhou, China
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Guangzhou, China
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Hangzhou, China
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Nanjing, China
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Nanning, China
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Shanghai, China
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Shenyang, China
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Suzhou, China
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Ürümqi, China
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Wuhan, China
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Xi'an, China
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Xi'an, China
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Yangzhou, China
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Ostrava, Czechia
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Caen, France
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Créteil, France
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Lyon, France
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Nantes, France
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Toulon Naval, France
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Villejuif, France
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Bad Berka, Germany
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Berlin, Germany
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Gauting, Germany
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Halle, Germany
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Heidelberg, Germany
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Karlsruhe, Germany
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Lübeck, Germany
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München, Germany
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Villingen-Schwenningen, Germany
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Farkasgyepü, Hungary
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Gyöngyös - Mátraháza, Hungary
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Miskolc, Hungary
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Székesfehérvár, Hungary
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Tatabánya, Hungary
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Zalaegerszeg, Hungary
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Haifa, Israel
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Kfar Saba, Israel
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Petah Tikva, Israel
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Tel Litwinsky, Israel
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Cremona, Italy
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Lecce, Italy
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Lecco, Italy
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Orbassano, Italy
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Parma, Italy
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Roma, Italy
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Sondrio, Italy
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Terni, Italy
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Chūōku, Japan
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Fukuoka, Japan
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Hirakata-shi, Japan
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Kanazawa, Japan
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Kashiwa, Japan
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Kobe, Japan
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Matsuyama, Japan
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Natori-shi, Japan
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Osaka, Japan
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Osakasayama-shi, Japan
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Sagamihara-shi, Japan
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Sakaishi, Japan
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Sendai, Japan
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Sunto-gun, Japan
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Yokohama, Japan
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Yokohama, Japan
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Yokohama, Japan
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Yokohama, Japan
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Kuala Lumpur, Malaysia
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Kuantan, Malaysia
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Kuching, Malaysia
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Cebu, Philippines
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Manila, Philippines
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Quezon City, Philippines
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Brzozoów, Poland
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Otwock, Poland
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Poznan, Poland
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Szczecin, Poland
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Warsaw, Poland
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Amadora, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Vila Nova de Gaia, Portugal
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Bucharest, Romania
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Bucharest, Romania
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Craiova, Romania
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Cheongju-si, South Korea
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Incheon, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Lleida, Spain
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Lugo, Spain
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Madrid, Spain
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Málaga, Spain
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Seville, Spain
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Zaragoza, Spain
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Linköping, Sweden
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Lucerne, Switzerland
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Winterthur, Switzerland
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Zurich, Switzerland
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Tainan, Taiwan
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Taoyuan, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Bangkok, Thailand
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Hat Yai, Thailand
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Muang, Thailand
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Dnipro, Ukraine
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Kryvyi Rih, Ukraine
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Lviv, Ukraine
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Sumy, Ukraine
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Edinburgh, United Kingdom
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London, United Kingdom
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Maidstone, United Kingdom
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Withington, United Kingdom
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Hanoi, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam