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ADRIATIC: For patients with Small-Cell Lung Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about how the study drugs (Durvalumab and Tremelimuma) can help treat people with small cell lung cancer.
What is the Condition Being Studied?
Lung Cancer (small cell lung cancer)- Limited stage

Who Can Participate in the Study?

- Adults diagnosed with small cell lung cancer
- Have had 4 cycles of chemotherapy
- Have had 4 cycles of radiation therapy

Age Group
Adults

What is Involved?

If you choose to join this study you will:
- Have clinic visits every 4 weeks for your treatment (up to 2 years if treatment is working)
- Be randomized (like drawing numbers out of a hat) to one of 3 groups:
-- Group 1 will get both study drugs (Durvalumab + Tremelimumab)
-- Group 2 will get the study drug Durvalumab and a placebo (harmless like salt water)
-- Group 3 will get the placebo only (harmless like salt water)

Study Details

Full Title
A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC) D933QC00001
Principal Investigator
Head and Neck Oncologist
Protocol Number
IRB: PRO00101141
NCT: NCT03703297
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698