NCT05467748 EZH2 Inhibitor, Tulmimetostat, and PD-1 Blockade for Treatment of Advanced Non-small Cell Lung Cancer
| NCT ID | NCT05467748 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2027-12-08 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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/L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria: 1. Has received at least 2 doses of an approved anti-PD-1/L1 mAb. 2. Has demonstrated disease progression after anti-PD-1/L1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a seco
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