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UM1 10021 Durvalumab & Tremelimumab +/- Radiation in mCRC & NSCLC - Clinical Trial

What is the Purpose of this Study?

We are doing this study to test any good and bad effects of the experimental study drugs, MEDI4736 (durvalumab) and tremelimumab given alone or in combination with either low or higher doses of radiation.

What is the Condition Being Studied?

Advanced non-small cell lung cancer

Who Can Participate in the Study?

Adults with advanced non-small cell lung cancer that has progressed after receiving prior treatment(s)

Age Group
Adults

What is Involved?

If you join this study, you will receive one of the three treatment options. The study group you will belong to will be decided by chance (like tossing a coin) because no one knows if one study group is better than the other

Group 1 will receive MEDI4736 (durvalumab) & tremelimumab only

Group 2 will receive MEDI4736 (durvalumab) & tremelimumab and 3 radiation treatments delivered on 3 different days. (each dose of radiation will be given to a higher dose than in group 3)

Group 3 will receive MEDI4736 (durvalumab) & tremelimumab and 4 radiation treatments delivered twice a day for 2 days during each of the first 4 cycles of treatment (each dose of radiation will be given to a lower dose than in group 2).

Study Details

Full Title
A Phase 2 Study of MEDI4736 (durvalumab) and Tremelimumab Alone or in Combination with High or Low-Dose Radiation in Metastatic Colorectal and NSCLC
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00085875
NCT:NCT02888743
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698