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GDFATHER-CTL002004 (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 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).

What is the Condition Being Studied?

Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Who Can Participate in the Study?

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.

Grupo etario
Adultos

What is Involved?

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.

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
Especialista en oncología médica
Protocol Number
IRB: PRO00118035
Phase
Phase II
Estado de inscripción
Pronto disponible para inscripción