Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called visugromab (CTL-002 - the study drug). We want to find out how beneficial this drug is when it is used in combination with immunochemotherapy for people with metastatic non-squamous non-small cell lung cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are newly diagnosed with stage IV non-squamous NSCLC
- Have not received prior systemic treatment for advanced/metastatic NSCLC
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will start with the safety run-in portion of this study. During this part, different doses of the study drug will be tested to determine which dose will be given during the randomized part.
When you proceed to the randomized part of the study, you will get a random assignment (by chance) to either take the study drug or a placebo (inactive substance that has no drug in it). You will have a 2-in-3 chance of getting the study drug.
Regardless of whether or not you are assigned to get the study drug, you will still receive the standard immunochemotherapy that is used to treat this diagnosis. The study drug/placebo regimen in this study will last for up to 2 years.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab versus Placebo, in Combination with Pembrolizumab, Pemetrexed, and Carboplatin, in First-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-01)
Principal Investigator
Joel
Rivera concepcion
Protocol Number
PRO00117662
Phase
II
Enrollment Status
Pending Open to Enrollment