Phase Ib/II Study of Safety and Efficacy of EZH2 Inhibitor, Tulmimetostat, and PD-1 Blockade for Treatment of Advanced Non-small Cell Lung Cancer
VA Office of Research and Development
Summary
This is an open label, single arm, phase Ib/II clinical trial of checkpoint blockade, pembrolizumab and EZH2 inhibitor, tulmimetostat combination therapy for patients with advanced non-small cell lung cancer who have progressed from front or second-line treatment. Patients will be enrolled at multiple Veterans Affairs Medical Centers.
Description
It is pleasing to witness the fulfillment of the promise of cancer immunotherapy becoming a reality for patients with many types of advanced cancer. However, even with this remarkable progress, majority of patients are not responding and substantial number of patients are progressing after initial response to checkpoint blockade immunotherapy. The field is undertaking major task to identify suitable combinatorial approach to improve the efficacy of checkpoint blockade immunotherapy and biomarker for better patient selection. Evidence suggests that EZH2 (Enhancer Zeste Homolog: enzymatic compon…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provide written informed consent/assent for the trial. The trial consent includes future biomedical research. * Male/female participants who are at least 18 years of age on the day of signing informed consent * Patients with histologically confirmed diagnosis of advanced non-small cell lung cancer. * Have a life expectancy of 12 weeks * Participants who progressed from chemo(platinum-based)-immunotherapy, immunotherapy single agent or immuno-immuno combination therapies as front or second line of therapy. * Participants must have progressed on treatment with an anti-PD-1…
Interventions
- DrugTulmimetostat
combination of oral tazemetostat and intravenous pembrolizumab treatment for patients with advanced non-small cell lung cancer
Locations (5)
- VA Long Beach Healthcare System, Long Beach, CALong Beach, California
- VA Northern California Health Care System, Mather, CASacramento, California
- VA San Diego Healthcare System, San Diego, CASan Diego, California
- VA Ann Arbor Healthcare System, Ann Arbor, MIAnn Arbor, Michigan
- Michael E. DeBakey VA Medical Center, Houston, TXHouston, Texas