AEGEAN (Lung Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the outcomes of people with operable lung cancer can be improved by adding an experimental drug (durvalumab) to standard chemotherapy given before and after surgery.

What is the Condition Being Studied?

Operable Lung Cancer (Non-Small Cell Lung Cancer)

Who Can Participate in the Study?

Adults age 18 or older who:
- Are diagnosed with non-small cell lung cancer that is operable (stages 2 or 3)

For more information about who can be in this study, please contact the study team.

Age Group
Adults

What is Involved?

This study has 2 parts: a screening period and a study dosing period.

If you join this study, during the screening period you will:
- Have blood draws
- Visit the clinic for various tests to see if you’re eligible for the dosing period

If you're eligible for the dosing period, you will:
- Have blood draws
- Have imaging scans (CT and MRI)
- Be randomized (like flipping a coin) to get:
-- Before surgery: the study drug (durvalumab) given by injection into a vein or a placebo (inactive substance) plus standard chemotherapy (over a period of 12 weeks before surgery)
-- After surgery: the study drug or placebo for up to 1 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