Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

CatalYm GmbH GDFATHER (Metastatic Non-Squamous Non-Small Cell Lung Cancer) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Metastatic Non-Squamous Non-Small Cell Lung Cancer

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are newly diagnosed with stage IV non-squamous NSCLC
  • Have not received prior systemic treatment for advanced/metastatic NSCLC

For more information, contact the study team at annemarie.peters@duke.edu.

Age Group
Adults

What is Involved?

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.

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
Protocol Number
IRB: PRO00117662
NCT: NCT07098988
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
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