This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
825
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
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
Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles
Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population
Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.
Time frame: Up to approximately 15 weeks after randomization
Event-Free Survival (EFS) in modified intent to treat (mITT) population
An event is defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.
Time frame: Up to 5.5 years after first patient randomized.
Disease-free survival (DFS) in modified resected population
Time frame: From date of randomization to approximately 5.5 years after date of resection
Major Pathological Response (mPR) in modified intent to treat (mITT) population
Time frame: Up to approximately 15 weeks after randomization
Overall Survival (OS) in modified intent to treat (mITT) population
Time frame: From date of randomization to 5.5 years after randomization
Event-free survival (EFS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: From date of randomization to 5.5 years after randomization
pCR in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: Up to approximately 15 weeks after randomization
Disease-Free Survival (DFS) in PD-L1-TC ≥1% patients in modified resected population
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75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles
500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.
Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.
Research Site
Phoenix, Arizona, United States
Research Site
Duarte, California, United States
Research Site
Orange, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Boca Raton, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Wichita, Kansas, United States
Research Site
Ashland, Kentucky, United States
Research Site
Lexington, Kentucky, United States
...and 221 more locations
Time frame: From date of randomization to 5.5 years after date of resection
Major Pathological Response (mPR) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: Up to approximately 15 weeks after randomization
Overall Survival (OS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: From date of randomization to 5.5 years after randomization.
To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
Time frame: From date of screening to 6 months after last dose of IP
To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
Time frame: From date of screening to 6 months after last dose of IP
To assess the PK of durvalumab in blood
To assess concentration of durvalumab in bloodstream.
Time frame: From date of randomization to 2 months after resection
Presence of ADA for durvalumab
To evaluate the presence of antibodies following treatment with study medications.
Time frame: From date of randomization to 3 months after last dose of IP