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MP0250-CP202 (Non-Small Cell Lung Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the safety and effects of a study drug called MP0250 when it is combined with osimertinib.

MP0250 (study drug) is in the very early stages of testing. About 60 people have received this drug and this will be the first time that it is combined with osimertinib. Osimertinib is currently approved for the treatment of lung cancer.

What is the Condition Being Studied?

Non-small cell lung cancer (non-squamous type with an EGFR mutation)

Who Can Participate in the Study?

Adults who have advanced or unresectable non-small cell lung cancer (non-squamous type with an EGFR mutation) which has gotten worse after treatment with osimeritinib

Age Group
Adults

What is Involved?

The study will be conducted in two parts:
Part A is looking for the best dose of a study drug called MP0250 combined with osimertinib
Part B will further test the dose found in Part A . Whether you are in Part A or Part B will depend on when you enroll in the study.

You will need to come to Duke for study drug infusions (MP0250) every 3 weeks while also taking osimertinib by mouth once daily until there is evidence you are not benefiting from the study drugs.

You'll be in the study for about 30 months.

Study Details

Full Title
A Phase 1b/2, single-arm, open-label, multi-center study of MP0250 in combination with osimertinib in patients with EGFR-mutated non-squamous non-small cell lung cancer (NSCLC) pretreated with osimertinib
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00090699
NCT:NCT03418532
Phase
Phase I/II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698