Study on EZH2 Inhibitor Tulmimetostat and PD-1 Blockade for Advanced Non-Small Cell Lung Cancer

Sponsor: VA Office of Research and Development

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05467748

Provider View

This clinical trial is testing a new combination of drugs, tulmimetostat and pembrolizumab, to see if they can help treat advanced non-small cell lung cancer that has not responded to previous treatments. The study is being conducted at various Veterans Affairs Medical Centers.

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced non-small cell lung cancer using a combination of two drugs: tulmimetostat, an EZH2 inhibitor, and pembrolizumab, a PD-1 blocker. The trial aims to determine if this combination is safe and effective for patients whose cancer has progressed after initial treatments. The study will enroll patients at multiple Veterans Affairs Medical Centers and will focus on the safety and effectiveness of the treatment, as well as how long patients can live without the disease getting worse.

Description

This clinical trial is designed to test a new combination of drugs for treating advanced non-small cell lung cancer. The drugs being tested are tulmimetostat, which targets a protein called EZH2, and pembrolizumab, which is a type of immunotherapy that blocks PD-1. The study is open to patients whose cancer has not responded to previous treatments, including those who have already tried immunotherapy.

The trial will be conducted in two phases. In the first phase, researchers will determine the safest dose of tulmimetostat to use in combination with pembrolizumab. In the second phase, they will evaluate how well the treatment works in shrinking tumors and controlling the disease. The study will also look at how long patients can live without their cancer getting worse and how long the treatment's effects last.

Participants will receive tulmimetostat orally for seven days before starting pembrolizumab, which will be given intravenously every three weeks. The study will include up to 54 patients in the second phase, and researchers will monitor the safety and effectiveness of the treatment throughout the trial. The study will also involve collecting tumor and blood samples to better understand how the treatment works.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate in the trial.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of advanced non-small cell lung cancer.
  • Must have a life expectancy of at least 12 weeks.
  • Must have previously received and progressed from certain cancer treatments, including chemotherapy and immunotherapy.
  • Must have measurable disease as determined by specific medical criteria.
  • Must provide a tumor sample for analysis.
  • Must have adequate organ function and meet specific blood test criteria.
  • Must have a performance status score of 0 or 1, indicating good overall health.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a specified period after.
  • Men must agree to use effective contraception and refrain from donating sperm during the study and for a specified period after.

Exclusion Criteria

  • Cannot have a primary diagnosis of certain types of lung cancer.
  • Cannot have active brain metastases unless they have been treated and are stable.
  • Cannot be participating in another investigational study within four weeks prior to this study.
  • Cannot have previously received tulmimetostat or other similar drugs.
  • Cannot have certain genetic mutations or be immunotherapy-naïve.
  • Cannot have severe allergies to pembrolizumab.
  • Cannot have active autoimmune diseases requiring treatment.
  • Cannot have certain infections, including HIV or active hepatitis.
  • Cannot have a history of lung inflammation requiring steroids.
  • Cannot have received a live vaccine within 30 days prior to the study.
  • Cannot be taking certain medications that affect drug metabolism.
  • Cannot have had major surgery or radiation therapy recently.
  • Cannot have another progressing cancer.
  • Cannot have conditions affecting drug absorption.
  • Cannot have recent blood clots or organ transplants.
  • Cannot be pregnant or breastfeeding.
  • Cannot have a history of substance abuse or psychiatric disorders affecting study participation.

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