Study identifier:D9106C00001
ClinicalTrials.gov identifier:NCT03800134
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)
Non-small Cell Lung Cancer
Phase 3
No
Durvalumab, Carboplatin/Paclitaxel, Cisplatin/Gemcitabine, Pemetrexed/Cisplatin, Pemetrexed/Carboplatin
All
825
Interventional
18 Years - 120 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Nov 2022 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1: Durvalumab + platinum-based chemotherapy Durvalumab (MEDI4736) in concurrence with platinum-based chemotherapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: - carboplatin/paclitaxel - cisplatin/gemcitabine - pemetrexed/cisplatin - pemetrexed/carboplatin | Drug: Durvalumab Durvalumab IV (intravenous infusion) Other Name: MEDI4736 Drug: Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as per standard of care Drug: Cisplatin/Gemcitabine Cisplatin/Gemcitabine, as per standard of care Drug: Pemetrexed/Cisplatin Pemetrexed/Cisplatin, as per standard of care Drug: Pemetrexed/Carboplatin Pemetrexed/Carboplatin, as per standard of care |
Placebo Comparator: Arm 2: Placebo + platinum-based chemotherapy Placebo in concurrence with platinum-based chemotherapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: - carboplatin/paclitaxel - cisplatin/gemcitabine - pemetrexed/cisplatin - pemetrexed/carboplatin | Other: Placebo Placebo IV (intravenous infusion) Drug: Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as per standard of care Drug: Cisplatin/Gemcitabine Cisplatin/Gemcitabine, as per standard of care Drug: Pemetrexed/Cisplatin Pemetrexed/Cisplatin, as per standard of care Drug: Pemetrexed/Carboplatin Pemetrexed/Carboplatin, as per standard of care |