825
Participants
Start Date
December 6, 2018
Primary Completion Date
November 10, 2022
Study Completion Date
September 11, 2028
Durvalumab
1500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
Placebo
Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
Carboplatin
Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles
Cisplatin
75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles
Pemetrexed
500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
Paclitaxel
200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
Gemcitabine
1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.
Surgery
Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.
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Lead Sponsor
AstraZeneca
INDUSTRY