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UM1 9903 AZD9291 + Navitoclax (Non-Small Cell Lung Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the two drugs AZD9291 (osimertinib) and navitoclax, are safe if given together in treating non-small cell lung cancer.

What is the Condition Being Studied?

Metastatic non-small cell lung cancer that has a genetic mutation in the EGFR (epidermal growth factor receptor) gene that has returned after treatment.

Who Can Participate in the Study?

Adults with non-squamous NSCLC, with incurable advanced or metastatic disease

Age Group
Adults

What is Involved?

If you join this study you will be placed in either group 1 or group 2.
Each group will receive called an investigational drug combination of AZD9291 and navitoclax once a day by mouth on a 28 day cycle.
In Group 1: The first several study participants will receive the lowest dose of the study drugs.
If the study drugs do not cause serious side effects, the drugs will be given to other participants at higher doses.
The doses will continue to increase for each subgroup until side effects occur that require the dose to be lowered.
Once a dose is identified that does not cause serious side effects, the next part of the study will begin.

In Group 2: The dose of the study drugs you receive will depend on the best dose identified in the Group 1 part of this study.

You will receive the study drugs until your cancer grows or until side effects require you to stop. After you finish taking the study drugs, your doctor will continue to watch you for side effects for 30 days.

Study Details

Full Title
A Phase 1B Study of AZD9291 in Combination with Navitoclax in EGFR-mutant Non-Small Cell Lung Cancer Following Resistance to Initial EGFR Kinase Inhibitor
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00082309
NCT:NCT02520778
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698