EZH2 Inhibitor, Tulmimetostat, and PD-1 Blockade for Treatment of Advanced Non-small Cell Lung Cancer

Part of paid clinical trials in Long Beach, California.

Sponsor
VA Office of Research and Development
Study ID
NCT05467748
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tulmimetostat — DRUG
    combination of oral tazemetostat and intravenous pembrolizumab treatment for patients with advanced non-small cell lung cancer

Study Details

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.

Key Dates

Start date
Dec 8, 2025
Status verified
Jan 2026
Primary completion
Dec 8, 2027
Completion
Dec 7, 2029

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: combination of tulmimetostat and pembrolizumab
    Enrolled patients will receive combination treatment for whole study duration (2 years). For first cycle, patient will start tulmimetostat one week prior to start every 3 week pembrolizumab intravenous infusion (pembrolizumab will be given day 8 only for the first cycle, rest of cycles will be day 1 of each cycle).

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 2 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
VA Long Beach Healthcare System, Long Beach, CALong BeachCalifornia90822
Pankaj Gupta, MD
VA Northern California Health Care System, Mather, CASacramentoCalifornia95655-4200
Tianhong Li, MD
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161-0002
Paul Cheng, MD
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105-2303
Garth Strohbehn, MD
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Zhifang Zhao, PhD
713-791-1414
Michelle V Espiritu-Washburn, MBBS
(713) 794-7939
Daniel S Shin, MD PhD (PRINCIPAL_INVESTIGATOR)

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