Tazemetostat + PD-1 Blockade for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDaniel S Shin, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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

This trial is for adults with advanced non-small cell lung cancer who've seen their disease progress after anti-PD-1/L1 therapy. They must have good performance status (ECOG 0-1), provide a tumor tissue sample, and have measurable disease. Adequate organ function and agreement to use contraception are required. Those with certain infections, recent major surgery, active pneumonitis or autoimmune diseases, other cancers within 3 years, or severe hypersensitivity to pembrolizumab can't participate.

Inclusion Criteria

I am not pregnant and will use birth control during the trial.

I am fully active or can carry out light work.

My cancer has worsened despite treatment with an anti-PD-1/L1 drug.

+7 more

Exclusion Criteria

I have not needed treatment for an autoimmune disease in the last 2 years.

You are pregnant at the time of the study treatment.

My lung cancer is a low to intermediate grade neuroendocrine type.

+18 more

Participant Groups

The study tests the combination of Tazemetostat (an EZH2 inhibitor) and Pembrolizumab (a checkpoint blockade therapy) in patients with advanced non-small cell lung cancer at multiple Veterans Affairs Medical Centers. It's an open-label phase Ib/II trial where all participants receive the same treatment without a comparison group.

1Treatment groups

Experimental Treatment

Group I: combination of tulmimetostat and pembrolizumabExperimental Treatment1 Intervention

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).

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: