A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects with Advanced Non-small Cell Lung Carcinoma

SUMMARY

This research study is being done because the Sponsor is studying a new investigational drug called ACP-196. An investigational drug is one that is being tested and is not yet approved for sale by the U.S Food and Drug Administration (FDA), or in any country, but may be used in research studies such as this one.

 

ACP-196 (hereafter called the study drug) is a type of drug that blocks proteins inside cells that help cells live and grow.  The specific protein blocked by the study drug is believed to help blood cancer cells live and grow.  It is possible that the study drug may kill the cancer cells or stop them from growing.

 

Keytruda is a drug that has already been approved for the treatment of a type of skin cancer called metastatic melanoma, but not the treatment of lung cancer.

 

In this study, there will be 2 different groups of subjects: Group 1 subjects will receive Keytruda (pembrolizumab) by intravenous (IV) administration every 3 weeks.  Group 2 subjects will be given the study drug and will also receive Keytruda (pembrolizumab) by intravenous (IV) administration every 3 weeks.  The same number of patients will be selected for each Group 1 and Group 2 so you will have an equal chance of being selected for each group.  The sponsor makes the decision which group you are assigned to and your doctor will not have this choice.

 

The purpose of the study is to find out if the study drug will slow or stop your cancer from getting worse and whether the study drug causes side effects.  The second purpose is to measure whether your cancer responds to the study drug.

 

Blood tests and specialized imaging (X-rays or CT scans) will be performed to see the way your cancer cells and immune system respond to the study drug.  Routine blood tests and urine tests are done for testing the safety of the study drug.

ACP-196 (hereafter called the study drug) is a type of drug that blocks proteins inside cells that help cells live and grow.  The specific protein blocked by the study drug is believed to help blood cancer cells live and grow.  It is possible that the study drug may kill the cancer cells or stop them from growing.

 

Keytruda is a drug that has already been approved for the treatment of a type of skin cancer called metastatic melanoma, but not the treatment of lung cancer.

 

In this study, there will be 2 different groups of subjects: Group 1 subjects will receive Keytruda (pembrolizumab) by intravenous (IV) administration every 3 weeks.  Group 2 subjects will be given the study drug and will also receive Keytruda (pembrolizumab) by intravenous (IV) administration every 3 weeks.  The same number of patients will be selected for each Group 1 and Group 2 so you will have an equal chance of being selected for each group.  The sponsor makes the decision which group you are assigned to and your doctor will not have this choice.

COH Protocol Number : 15136

ClinicalTrials.gov Number : NCT02448303

Principal Investigator : Reckamp, Karen M.D.

Sponsor : Acerta Pharma BV

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : N/A

Gender : Either

Minimum Performance Status : ECOG/SWOG:1

Treatment Intent : Adjuvant treatment

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :