AEGEAN Early stage (operable) NSCLC - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the study drug will work (delay the cancer coming back) and to find out if it is safe when combined with chemotherapy for operable lung cancer.

What is the Condition Being Studied?

Early Stage (stages 2 or 3, operable) Non-Small Cell Lung Cancer

Who Can Participate in the Study?

-Adults, 18+
-Have a diagnosis of operable stage 2 or 3 non-small cell lung cancer

For more information on who can participate in this study please contact the study team.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Have a physical exam
-Have blood samples taken
-Have scans to measure your tumor
-Be assigned by chance (a fair 50/50 chance) to group1 or Group 2
---Group 1 will get the study drug (durvalumab) plus chemotherapy over 12 weeks before surgery
---Group 2 will get a placebo (harmless, inactive substance) over 12 weeks plus chemotherapy before surgery

After surgery, you will receive just study drug or the placebo for up to one year.

Study Details

Full Title
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) D9106C00001
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00102104
NCT: NCT03800134
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698