674
Participants
Start Date
December 3, 2014
Primary Completion Date
June 19, 2017
Study Completion Date
December 31, 2025
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.
Research Site, Taoyuan
Research Site, Taichung
Research Site, Tainan City
Research Site, Kaohsiung City
Research Site, Manila
Research Site, Quezon City
Research Site, Sofia
Research Site, Camperdown
Research Site, Kogarah
Research Site, Tatabánya
Research Site, Leuven
Research Site, Heidelberg
Research Site, Clayton
Research Site, Gyöngyös - Mátraháza
Research Site, Miskolc
Research Site, Liège
Research Site, Chermside
Research Site, Woolloongabba
Research Site, Seoul
Research Site, Cebu
Research Site, Lucerne
Research Site, Nedlands
Research Site, Ankara
Research Site, Székesfehérvár
Research Site, Zurich
Research Site, Winterthur
Research Site, Farkasgyepü
Research Site, Roeselare
Research Site, Zalaegerszeg
Research Site, Hanoi
Research Site, Orbassano
Research Site, Bangkok
Research Site, Bangkok
Research Site, Bangkok
Research Site, Berlin
Research Site, Seongnam-si
Research Site, A Coruña
Research Site, Bethesda
Research Site, Sondrio
Research Site, Lübeck
Research Site, Lecco
Research Site, Kuantan
Research Site, Lleida
Research Site, Cremona
Research Site, Lugo
Research Site, Madrid
Research Site, Salisbury
Research Site, Cheongju-si
Research Site, Málaga
Research Site, Marietta
Research Site, Atlanta
Research Site, Atlanta
Research Site, Haifa
Research Site, Tampa
Research Site, Istanbul
Research Site, Izmir
Research Site, Sumy
Research Site, Louisville
Research Site, Seville
Research Site, Parma
Research Site, Nantes
Research Site, Petah Tikva
Research Site, Dnipro
Research Site, Zaragoza
Research Site, Kryvyi Rih
Research Site, Muang
Research Site, Tel Litwinsky
Research Site, Minneapolis
Research Site, Kuala Lumpur
Research Site, Heidelberg
Research Site, Lyon
Research Site, Ho Chi Minh City
Research Site, Lecce
Research Site, Tainan City
Research Site, Karlsruhe
Research Site, Villingen-Schwenningen
Research Site, Lviv
Research Site, München
Research Site, Gauting
Research Site, Toulon Naval
Research Site, Hat Yai
Research Site, West Hills
Research Site, Anaheim
Research Site, Kuching
Research Site, Créteil
Research Site, Villejuif
Research Site, Santa Rosa
Research Site, Bad Berka
Research Site, Hanoi
Research Site, Beijing
Research Site, Beijing
Research Site, Shenyang
Research Site, Changchun
Research Site, Changchun
Research Site, Saint Petersburg
Research Site, Saint Petersburg
Research Site, Saint Petersburg
Research Site, Craiova
Research Site, Shanghai
Research Site, Nanjing
Research Site, Suzhou
Research Site, Yangzhou
Research Site, Hangzhou
Research Site, Fuzhou
Research Site, Chongqing
Research Site, Chongqing
Research Site, Chongqing
Research Site, Wuhan
Research Site, Guangzhou
Research Site, Nanning
Research Site, Xi'an
Research Site, Xi'an
Research Site, Ürümqi
Research Site, Kfar Saba
Research Site, Boston
Research Site, Lebanon
Research Site, Burlington
Research Site, Porto Alegre
Research Site, Edmonton
Research Site, Hamilton
Research Site, Ottawa
Research Site, Toronto
Research Site, Toronto
Research Site, Toronto
Research Site, Ostrava
Research Site, Caen
Research Site, Halle
Research Site, Roma
Research Site, Terni
Research Site, Chūōku
Research Site, Fukuoka
Research Site, Hirakata-shi
Research Site, Kanazawa
Research Site, Kashiwa
Research Site, Kobe
Research Site, Matsuyama
Research Site, Natori-shi
Research Site, Osaka
Research Site, Osakasayama-shi
Research Site, Sagamihara-shi
Research Site, Sakaishi
Research Site, Sendai
Research Site, Sunto-gun
Research Site, Yokohama
Research Site, Yokohama
Research Site, Yokohama
Research Site, Yokohama
Research Site, Brzozoów
Research Site, Otwock
Research Site, Poznan
Research Site, Szczecin
Research Site, Warsaw
Research Site, Amadora
Research Site, Lisbon
Research Site, Porto
Research Site, Vila Nova de Gaia
Research Site, Bucharest
Research Site, Bucharest
Research Site, Incheon
Research Site, Seoul
Research Site, Seoul
Research Site, Seoul
Research Site, Barcelona
Research Site, Barcelona
Research Site, Barcelona
Research Site, Linköping
Research Site, Edinburgh
Research Site, London
Research Site, Maidstone
Research Site, Withington
Lead Sponsor
Collaborators (1)
Parexel
INDUSTRY
AstraZeneca
INDUSTRY