Actively Recruiting
EZH2 Inhibitor, Tulmimetostat, and PD-1 Blockade for Treatment of Advanced Non-small Cell Lung Cancer
Led by VA Office of Research and Development · Updated on 2026-01-27
66
Participants Needed
5
Research Sites
208 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
V
VA Greater Los Angeles Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EZH2 Inhibitor, Tulmimetostat, and PD-1 Blockade for Treatment of Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for the trial including future biomedical research.
- Male or female participants aged 18 years or older at consent.
- Histologically confirmed advanced non-small cell lung cancer diagnosis.
- Life expectancy of at least 12 weeks.
- Progressed after platinum-based chemotherapy and immunotherapy, or immunotherapy alone, as front or second-line treatment.
- Progressed on anti-PD-1 or PD-L1 monoclonal antibody treatment, with at least 2 doses received and disease progression confirmed by RECIST v1.1.
- Measurable disease according to RECIST v1.1.
- Provided archival tumor sample or recent tumor biopsy.
- Adequate organ function within 10 days before starting study treatment.
- ECOG performance status of 0 or 1.
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before treatment and agree to use effective contraception through 183 days after last dose.
- Male participants and their partners of childbearing potential must use effective contraception through 183 days after last dose.
You will not qualify if you...
- Diagnosis of low to intermediate grade neuroendocrine lung cancer.
- Active cerebral metastases requiring steroids within the last month.
- Participation in another investigational drug study within 4 weeks prior to enrollment.
- Previous treatment with tulmimetostat or other EZH2 inhibitors.
- Presence of EGFR or ALK gene alterations.
- Immunotherapy-na�ve patients.
- History of severe hypersensitivity to pembrolizumab (Grade 3).
- Active autoimmune disease requiring systemic treatment within past 2 years or severe autoimmune disease requiring immunosuppression.
- Positive for HIV, active Hepatitis B or C infection.
- History of pneumonitis requiring steroids or current pneumonitis.
- Active infection needing systemic therapy.
- Received live virus vaccine within 30 days prior to study drug.
- Use of strong CYP3A4 inducers or inhibitors within 7 days before study drug.
- Recent major surgery or radiotherapy within specified washout periods.
- Additional progressing malignancy requiring treatment within past 3 years.
- Inability to take oral medication or gastrointestinal conditions affecting drug absorption.
- Venous thromboembolism or pulmonary embolism within 3 months before study.
- History of allogenic tissue or organ transplantation.
- Pregnant or breastfeeding women or those planning pregnancy or fatherhood during the study period.
- Current illicit drug use or recent substance abuse.
- Psychiatric disorders interfering with study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Not Yet Recruiting
2
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States, 95655-4200
Not Yet Recruiting
3
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
Actively Recruiting
4
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
Actively Recruiting
5
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
Research Team
D
Daniel S Shin, MD PhD
CONTACT
Q
Quillan Huang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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