GC4711 for early stage non-small cell lung cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to understand if GC4711 is safe and effective when combined with radiation therapy.

This study is important because tumors may be better controlled with radiation and GC4711 combined than with radiation alone.

What is the Condition Being Studied?

People with early stage non-small cell lung cancer (NSCLC)

Who Can Participate in the Study?

Adults age 18 and older who:
-Have non small cell lung cancer that has not spread (metastasized)
-Have normal organ function
-Are able to lie down with arms over your head and can breathe normally
-Have not been treated with immunotherapy before
-Have not had radiation to the same area before
-Agree to use contraception (birth control) while in the study if you are able to have children

For more information about who can be in this study, please contact the study team.

Age Group
Adults

What is Involved?

If you choose to join the study, you will:
-Go through a screening period that lasts about 3 weeks and includes review of your medical record, test results, and one clinic visit
-Have radiation therapy called stereotactic body radiation therapy (SBRT), which is standard therapy for your disease

There are 2 phases of this study
-If you are enrolled in the Phase 1, you will get the study drug (GC4711) by 15 minute IV (into the vein) infusion daily for 5 days
-If you are enrolled in the Phase 2 portion, you will be randomized (like flipping a coin) to get:
-- A study drug (GC4711) by 15 minute IV (into the vein) infusion daily for 5 days
-- A placebo (harmless sugar water) by 15 minute IV (into the vein) infusion daily for 5 days

Everyone who participates will be asked to complete follow-up for 1 year.
During the follow-up time you will:
-Have monthly study visits
-At some visits you will have a physical exam, blood tests, lung function tests and a CT scan
-At some visits you will also complete questionnaires about how you are feeling and medications you are taking.

Study Details

Full Title
Phase 1/2 Study of Stereotactic Body Radiation Therapy (SBRT) with or without GC4711 for Early Stage, Centrally Located or Large Non-Small Cell Lung Cancer (NSCLC)
Principal Investigator
Radiation Oncologist
Protocol Number
IRB: PRO00106862
NCT: NCT04476797
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698