GDFATHER-CTL002004 (Non-Small Cell Lung Cancer)

Purpose of this Study

We are doing this study to find the most effective, safe dose of an experimental drug called CTL-002 (the study drug) when it is given in combination with nivolumab and docetaxel for patients who have metastatic non-squamous non-small cell lung cancer (NSCLC).

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with stage IV non-squamous NSCLC
  • Do not have any known mutations (e.g. EGFR, ALK, among others) that can guide treatment with an available targeted agent
  • Have not have received more than one line of prior systemic treatment for advanced/metastatic NSCLC
For more information about who can join this study, contact the study team at annemarie.peters@duke.edu.

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 get a random assignment (by chance) to 1 of 4 different study groups. The possible group assignments are as follows:
  • Group A: If you are in this group, you will get the study drug and nivolumab along with docetaxel.
  • Group B: If you are in this group, you will get the study drug and nivolumab along with docetaxel, but the study drug will be given at a lower dose than Group A.
  • Group C: If you are in this group, you will get the study drug and nivolumab without docetaxel. The dose of the study drug will be the same as the dose used in Group A.
  • Group D: If you are in this group, you will get docetaxel on its own.
You will get the drug(s) in your assigned group every 3 weeks 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 plus Nivolumab with or without Docetaxel versus Docetaxel Monotherapy in Second-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-02)

Principal Investigator

Joel
Rivera concepcion

Protocol Number

PRO00118035

Phase

II

Enrollment Status

Pending Open to Enrollment