A Phase IB/IIA Study of GSK3377794 Alone or with Pembrolizumab Immunotherapy in People with Advanced or Recurrent Non-Small Cell Lung Cancer

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Full Title

A Phase 1b/2a Pilot Randomized Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794) Alone, or in Combination with Pembrolizumab in HLA-A2+ Participants with NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer

Purpose

The purpose of this study is to see if the investigational drug GSK3377794 is safe when used alone and in combination with pembrolizumab immunotherapy in patients with advanced and recurrent non-small cell lung cancer (NSCLC). GSK3377794 is made by taking some T cells from a patient, modifying them in the laboratory to recognize two proteins (NY-ESO-1 and LAGE-1a) found on some NSCLC tumors, and returning the modified T cells to the patient so they can find and kill lung cancer cells. Pembrolizumab also boosts the immune system’s ability to find and kill cancer cells, but through a different mechanism than GSK3377794.

Patients will receive GSK3377794 alone or with pembrolizumab. Those who receive GSK3377794 alone and whose cancer continues to grow will have the option to also receive pembrolizumab at that point. Both GSK3377794 and pembrolizumab are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have NSCLC that is stage IIIB or IV or has come back after prior treatment.
  • Patients’ tumors must be positive for NY-ESO-1 and/or LAGE-1a.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Marjorie G. Zauderer at 646-888-4656.

Protocol

19-262

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators