Patients with resectable Non-small Cell Lung Cancer (Stage IIA to IIIB; either squamous or non-squamous).
Conditions
Brief summary
Event-free Survival (EFS) and pathological Complete Response (pCR) in modified intent-to-treat (mITT).
Detailed description
DFS in the modified resected population., mPR (≤10% viable tumour cells in lung primary tumour after complete evaluation in the resected lung cancer specimen)., OS., EFS, pCR, DFS, mPR, OS in the population with PD-L1 TC ≥1%., Change from baseline in Patient reported outcomes and time to deterioration., Concentration of durvalumab., Presence of ADAs for durvalumab.
Interventions
DRUGPACLITAXEL
DRUGGEMCITABINE HYDROCHLORIDE
DRUGMYCOPHENOLATE MOFETIL
DRUGGEMCITABINE
DRUGCISPLATIN
DRUGINFLIXIMAB
DRUGCARBOPLATIN
DRUGPEMETREXED
DRUGPEMETREXED DISODIUM
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free Survival (EFS) and pathological Complete Response (pCR) in modified intent-to-treat (mITT). | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS in the modified resected population., mPR (≤10% viable tumour cells in lung primary tumour after complete evaluation in the resected lung cancer specimen)., OS., EFS, pCR, DFS, mPR, OS in the population with PD-L1 TC ≥1%., Change from baseline in Patient reported outcomes and time to deterioration., Concentration of durvalumab., Presence of ADAs for durvalumab. | — |
Countries
Austria, Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Spain
Outcome results
None listed