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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
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 belowSelect...
I am fully active or can carry out light work.
Select...
My cancer has worsened despite treatment with an anti-PD-1/L1 drug.
Select...
I have provided a sample of my tumor that has not been treated with radiation.
Select...
My cancer can be measured by scans.
Select...
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:Select...
My lung cancer is a low to intermediate grade neuroendocrine type.
Select...
I am taking strong medication that affects liver enzyme levels.
Select...
I am currently being treated for an infection.
Select...
I have had lung inflammation treated with steroids or have it now.
Select...
I have recovered from major surgery without any significant infection.
Select...
I have active brain metastases.
Select...
I have previously been treated with tazemetostat or similar medications.
Select...
I have received a transplant from another person.
Select...
I have another cancer that is getting worse or was treated in the last 3 years.
Select...
I cannot take pills by mouth or have a condition that affects how my body absorbs nutrients.
Select...
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
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
Side effects data
From 2021 Phase 2 trial • 20 Patients • NCT0345672653%
Dysgeusia
41%
Nasopharyngitis
29%
Upper respiratory tract infection
29%
Blood creatine phosphokinase increased
29%
Lymphopenia
29%
Constipation
29%
Stomatitis
24%
Rash
18%
Blood creatinine increased
18%
Weight decreased
18%
Thrombocytopenia
18%
Neutropenia
18%
Nausea
12%
Herpes simplex
12%
Amylase increased
12%
Malaise
12%
Pneumonia
12%
Urinary tract infection
12%
Influenza
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Osteonecrosis of jaw
6%
Hypoalbuminaemia
6%
Blood pressure decreased
6%
Rash maculo-papular
6%
Blood zinc decreased
6%
Gamma-glutamyltransferase increased
6%
Phlebitis
6%
Nail disorder
6%
Musculoskeletal chest pain
6%
Gastric cancer
6%
Traumatic intracranial haemorrhage
6%
Pyrexia
6%
Electrocardiogram QT prolonged
6%
Aspartate aminotransferase increased
6%
Non-small cell lung cancer
6%
Fatigue
6%
Oedema peripheral
6%
Impetigo
6%
Haematochezia
6%
Tooth disorder
6%
Bronchitis
6%
Gastroenteritis
6%
Abdominal pain
6%
Large intestine polyp
6%
Pneumocystis jirovecii pneumonia
6%
Hypogammaglobulinaemia
6%
Traumatic fracture
6%
Alanine aminotransferase increased
6%
Myalgia
6%
Visual field defect
6%
Insomnia
6%
Haematuria
6%
Hypertonic bladder
6%
Upper respiratory tract inflammation
6%
Skin exfoliation
6%
Immature granulocyte count increased
6%
Cataract
6%
Mechanical ileus
6%
Atypical pneumonia
6%
Periodontitis
6%
Pneumonia aspiration
6%
Leukopenia
6%
Pericardial effusion
6%
Conjunctival haemorrhage
6%
Visual impairment
6%
Epigastric discomfort
6%
Oral herpes
6%
Paronychia
6%
Fall
6%
Postoperative delirium
6%
Procedural pain
6%
Skin laceration
6%
Tooth fracture
6%
Hyperglycaemia
6%
Hyperkalaemia
6%
Hyperuricaemia
6%
Pain in extremity
6%
Tendon disorder
6%
Myelodysplastic syndrome
6%
Muscle spasticity
6%
Peripheral motor neuropathy
6%
Sciatica
6%
Syncope
6%
Asthma
6%
Dysphonia
6%
Erythema multiforme
6%
Keloid scar
100%
80%
60%
40%
20%
0%
Study treatment Arm
Participants With Follicular Lymphoma
Participants With Diffuse Large B-cell Lymphoma
Trial Design
1Treatment groups
Experimental Treatment
Group I: combination of tazemetostat and pembrolizumabExperimental Treatment1 Intervention
Enrolled patients will receive combination treatment for whole study duration (2 years). For first cycle, patient will start tazemetostat 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~1050
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,004 Total Patients Enrolled
VA Greater Los Angeles Healthcare SystemFED
51 Previous Clinical Trials
8,501 Total Patients Enrolled
Daniel S Shin, MD PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, West Los Angeles, CA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and will use birth control during the trial.I have not needed treatment for an autoimmune disease in the last 2 years.You are pregnant at the time of the study treatment.I am fully active or can carry out light work.My lung cancer is a low to intermediate grade neuroendocrine type.I am taking strong medication that affects liver enzyme levels.I am currently being treated for an infection.I have had lung inflammation treated with steroids or have it now.You have HIV, active Hepatitis B, or active Hepatitis C.I have recovered from major surgery without any significant infection.My cancer has worsened despite treatment with an anti-PD-1/L1 drug.I have active brain metastases.I have previously been treated with tazemetostat or similar medications.I had radiotherapy less than 4 weeks ago.I have received a transplant from another person.I have another cancer that is getting worse or was treated in the last 3 years.I have not received a live vaccine in the last 30 days.I cannot take pills by mouth or have a condition that affects how my body absorbs nutrients.I have not had a blood clot in my veins or lungs in the last 3 months.I am a man who can father children and agree to use birth control and not donate sperm.You are currently using illegal drugs or have recently had a problem with substance abuse.I have provided a sample of my tumor that has not been treated with radiation.My cancer can be measured by scans.My blood tests for kidney, liver, and clotting are within normal ranges.I have had a severe allergic reaction to pembrolizumab.I have received more than 30 Gy of radiation therapy in the last 6 months.I am 18 or older with advanced lung cancer that has worsened after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: combination of tazemetostat and pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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