Tazemetostat for Non-Small Cell Lung Carcinoma (NSCLC)
Phase-Based Progress Estimates
Effectiveness
Safety
VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, CA
Non-Small Cell Lung Carcinoma (NSCLC)+2 More
Tazemetostat - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This is an open label, single arm, phase Ib/II clinical trial of checkpoint blockade, pembrolizumab and EZH2 inhibitor, tazemetostat 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.
Eligible Conditions
- Non-Small Cell Lung Carcinoma (NSCLC)
Treatment Effectiveness
Effectiveness Progress
Other trials for Non-Small Cell Lung Carcinoma (NSCLC)
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: 2 years
1 year
Progression Free Survival (PFS) and 1-year survival rate
2 years
Disease control rate (DCR)
Duration of Response (DOR)
Objective Response Rate (ORR)
Safety and Tolerability
Trial Safety
Safety Progress
Other trials for Non-Small Cell Lung Carcinoma (NSCLC)
Side Effects for
Part 1 (Pharmacokinetics)
54%Dyspnoea
46%Nausea
31%Fatigue
23%Cancer pain
23%Back pain
15%Cough
15%Dysphonia
15%Abdominal Distension
15%Decreased appetite
15%Pleural effusion
15%Vomiting
15%Lymphocyte count decreased
8%Haemorrhoids
8%Hypophosphataemia
8%Rash
8%Hypokalaemia
8%Dermatitis acneiform
8%Epistaxis
8%Oral candidiasis
8%Arthralgia
8%Pleural Effusion
8%Upper respiratory Tract Infection
8%Procedural pain
8%Throat Irritation
8%Abdominal pain
8%Asthenia
8%Hyperglycaemia
8%Night sweats
8%Dry skin
8%Insomnia
8%Gastrooesophageal Reflux Disease
8%Ascites
8%Dyspepsia
8%Neuralgia
8%Dermal cyst
8%Embolism
8%Dysphagia
8%Chills
8%Pyrexia
8%Oedema peripheral
0%Constipation
0%Dysgeusia
0%Renal failure
0%Urinary tract infection
0%Hyponatraemia
0%Deep vein thrombosis
0%Dizziness
0%Lower respiratory tract infection
0%Oxygen saturation decreased
0%Pneumoperitoneum
0%Squamous cell carcinoma of skin
0%Muscle spasms
0%Electrocardiogram T wave inversiontion
0%Sepsis
0%Pericardial Effusion
0%Liver abscess
0%Electrocardiogram ST segment elevation
0%Air embolism
0%Pneumonia
0%Peritonitis
0%Intestinal perforation
0%Systemic infection
0%Incarcerated umbilical hernia
0%General physical health deterioration
0%Syncope
0%Malignant ascites
0%Cancer Pain
0%Weight decreased
0%Anaemia
Trial Design
1 Treatment Group
combination of tazemetostat and pembrolizumab
1 of 1
Experimental Treatment
66 Total Participants · 1 Treatment Group
Primary Treatment: Tazemetostat · No Placebo Group · Phase 1 & 2
combination of tazemetostat and pembrolizumab
Drug
Experimental Group · 1 Intervention: Tazemetostat · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~760
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Closest Location: VA Greater Los Angeles Healthcare System, West Los Angeles, CA · West Los Angeles, CA
2003First Recorded Clinical Trial
2 TrialsResearching Non-Small Cell Lung Carcinoma (NSCLC)
48 CompletedClinical Trials
Who is running the clinical trial?
VA Greater Los Angeles Healthcare SystemFED
46 Previous Clinical Trials
8,041 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,459 Previous Clinical Trials
2,748,847 Total Patients Enrolled
2 Trials studying Non-Small Cell Lung Carcinoma (NSCLC)
40 Patients Enrolled for Non-Small Cell Lung Carcinoma (NSCLC)
Daniel S. Shin, MD, PhDStudy ChairVA Greater Los Angeles Healthcare System
Daniel S Shin, MD PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, West Los Angeles, CA
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You must provide informed consent/assent for the trial
Do not allow patients with EGFR or ALK sensitizing mutations.
You have received at least 2 doses of an approved anti-PD-1/L1 mAb.
You have a disease progression after anti-PD-1/L1 as defined by RECIST v1.1.
You have progressive disease documented within 12 weeks from the last dose of anti-PD-1/L1 mAb.
You have a progressive disease.
This determination is made by the investigator
You have measurable disease per RECIST v1.1 as assessed by the investigator and site radiologist.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments