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PD-1 Blockade

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

Phase 1 & 2

Waitlist Available

Led By Daniel S Shin, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG 0-1

Participants must have progressed on treatment with an anti-PD-1/L1 mAb

Must not have

Primary diagnosis of low to intermediate grade of neuroendocrine lung cancer

Taking medications known as strong CYP3A4 inducers/inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs to treat patients with advanced non-small cell lung cancer who have progressed from front or second-line treatment. The trial will enroll patients at multiple Veterans Affairs Medical Centers.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in various organs, infusion reactions from Pembrolizumab, fatigue, blood disorders like changes in white cells counts which may increase infection risk; liver enzyme alterations could indicate liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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

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I have provided a sample of my tumor that has not been treated with radiation.

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My cancer can be measured by scans.

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I am 18 or older with advanced lung cancer that has worsened after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am taking strong medication that affects liver enzyme levels.

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I am currently being treated for an infection.

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I have had lung inflammation treated with steroids or have it now.

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I have recovered from major surgery without any significant infection.

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I have active brain metastases.

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I have previously been treated with tazemetostat or similar medications.

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I have received a transplant from another person.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I cannot take pills by mouth or have a condition that affects how my body absorbs nutrients.

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I have had a severe allergic reaction to pembrolizumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Safety and Tolerability

Secondary study objectives

Disease control rate (DCR)

Duration of Response (DOR)

Progression Free Survival (PFS) and 1-year survival rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

0 / 16Eligibility criteria met