1,186
Participants
Start Date
June 1, 2017
Primary Completion Date
March 12, 2021
Study Completion Date
November 15, 2027
Durvalumab
IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until disease progression or other discontinuation criteria
Tremelimumab
IV infusions every 3 weeks for 12 weeks (4 cycles). An additional dose of tremelimumab will be administered in the week 16.
Abraxane + carboplatin
Standard of care chemotherapy (squamous and non-squamous patients): Abraxane 100 mg/m2 on Days 1, 8, and 15 of each 21-day cycle. Carboplatin Area under the plasma drug concentration-time curve (AUC) 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).
Gemcitabine + cisplatin
Standard of care chemotherapy (squamous patients only): Gemcitabine 1000 or 1250 mg/m2 via IV infusion on Days 1 and 8 of each 21-day cycle + cisplatin 75 mg/m2 via IV infusion on Day 1 of each 21-day cycle, for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).
Gemcitabine + carboplatin
Standard of care chemotherapy (squamous patients only): Gemcitabine 1000 or 1250 mg/m2 via IV infusion on Days 1 and 8 of each 21-day cycle + carboplatin AUC 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).
Pemetrexed + carboplatin
Standard of care chemotherapy (non-squamous patients only): Pemetrexed 500 mg/m2 and carboplatin AUC 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3); then continue pemetrexed 500 mg/m2 maintenance \[i.e., q4w for Treatment Arms 1 and 2. For Treatment Arm 3, Pemetrexed maintenance therapy can be given either q3w or q4w (dependent on Investigator decision and local standards)\] until objective disease progression.
Pemetrexed + cisplatin
Standard of care chemotherapy (non-squamous patients only): Pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 via IV infusion on Day 1 of each 21-day cycle, for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3); then continue pemetrexed 500 mg/m2 maintenance \[i.e., q4w for Treatment Arms 1 and 2. For Treatment Arm 3, Pemetrexed maintenance therapy can be given either q3w or q4w (dependent on Investigator decision and local standards)\] until objective disease progression.
Research Site, San Isidro
Research Site, Taipei
Research Site, Taipei
Research Site, Taoyuan District
Research Site, Budapest
Research Site, Budapest
Research Site, Sofia
Research Site, Sofia
Research Site, Sofia
Research Site, Sofia
Research Site, Vereeniging
Research Site, Törökbálint
Research Site, Parktown
Research Site, Miskolc
Research Site, Plovdiv
Research Site, Plovdiv
Research Site, Durban
Research Site, Kecskemét
Research Site, Seoul
Research Site, Cape Town
Research Site, Rondebosch
Research Site, Varna
Research Site, Taipei
Research Site, Bangkok
Research Site, Bangkok
Research Site, Bangkok
Research Site, Berlin
Research Site, Seongnam-si
Research Site, México
Research Site, Pittsburgh
Research Site, Aguascalientes
Research Site, Hamburg
Research Site, Vinnytsia
Research Site, Hamburg
Research Site, Incheon
Research Site, Richmond
Research Site, Kirovohrad
Research Site, Oldenburg
Research Site, Chungcheongbuk-do
Research Site, Tuxtla Gutiérrez
Research Site, Jacksonville
Research Site, West Palm Beach
Research Site, St. Petersburg
Research Site, Fort Myers
Research Site, Immenhausen
Research Site, Nashville
Research Site, Chattanooga
Research Site, Sumy
Research Site, Louisville
Research Site, Taichung
Research Site, Taichung
Research Site, Daegu
Research Site, Ulsan
Research Site, Guadalajara
Research Site, Canton
Research Site, Essen
Research Site, Busan
Research Site, Dnipro
Research Site, Changhua
Research Site, Muang
Research Site, Cuautitlán Izcalli
Research Site, Mainz
Research Site, Monterrey
Research Site, Kansas City
Research Site, Monterrey
Research Site, Odesa
Research Site, Zaporizhzhia
Research Site, Heidelberg
Research Site, Tainan City
Research Site, Ivano-Frankivsk
Research Site, Fort Worth
Research Site, Houston
Research Site, Lviv
Research Site, Freiburg im Breisgau
Research Site, Gauting
Research Site, Kaohsiung City
Research Site, Kaohsiung City
Research Site, Phoenix
Research Site, Songkhla
Research Site, Santa Monica
Research Site, Bakersfield
Research Site, Würzburg
Research Site, Hanoi
Research Site, Beijing
Research Site, Beijing
Research Site, Moscow
Research Site, Qingdao
Research Site, Moscow
Research Site, Moscow
Research Site, Moscow
Research Site, Changchun
Research Site, Harbin
Research Site, Saint Petersburg
Research Site, Saint Petersburg
Research Site, Saint Petersburg
Research Site, Saint Petersburg
Research Site, Shanghai
Research Site, Shanghai
Research Site, Shanghai
Research Site, Nanjing
Research Site, Yangzhou
Research Site, Hefei
Research Site, Linyi
Research Site, Hangzhou
Research Site, Fuzhou
Research Site, Changsha
Research Site, Wuhan
Research Site, Wuhan
Research Site, Zhengzhou
Research Site, Zhengzhou
Research Site, Guangzhou
Research Site, Shantou
Research Site, Zhanjiang
Research Site, Liuzhou
Research Site, Omsk
Research Site, Ho Chi Minh City
Research Site, Xining
Research Site, Barretos
Research Site, Belo Horizonte
Research Site, Curitiba
Research Site, Porto Alegre
Research Site, Porto Alegre
Research Site, Porto Alegre
Research Site, Ribeirão Preto
Research Site, Rio de Janeiro
Research Site, Santo André
Research Site, Santo André
Research Site, São José do Rio Preto
Research Site, São Paulo
Research Site, São Paulo
Research Site, São Paulo
Research Site, Kunming
Research Site, Shatin
Research Site, Bunkyō City
Research Site, Chūōku
Research Site, Fukuoka
Research Site, Hiroshima
Research Site, Iwakuni-shi
Research Site, Kanazawa
Research Site, Kashiwa
Research Site, Kōtoku
Research Site, Kurume-shi
Research Site, Matsuyama
Research Site, Okayama
Research Site, Okayama
Research Site, Sapporo
Research Site, Sayama
Research Site, Sunto-gun
Research Site, Toyoake-shi
Research Site, Ube-shi
Research Site, Yokohama
Research Site, Yokohama
Research Site, Mexico City
Research Site, México
Research Site, Arequipa
Research Site, Lima
Research Site, Lima
Research Site, Lima
Research Site, Lima
Research Site, Olsztyn
Research Site, Tomaszów Mazowiecki
Research Site, Warsaw
Research Site, Wodzisław Śląski
Research Site, Johannesburg
Research Site, Pretoria
Research Site, Seoul
Research Site, Seoul
Research Site, Seoul
Research Site, Kyiv
Research Site, Kyiv
Research Site, Leicester
Research Site, London
Research Site, London
Research Site, London
Research Site, Manchester
Lead Sponsor
AstraZeneca
INDUSTRY