Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a combination of drugs to treat small cell lung cancer that has come back after a period of treatment. The drugs work in different ways to stop the growth of tumor cells. The combination of these drugs may shrink or stabilize the cancer.
Eligible Conditions
- Small cell carcinoma of lung
- Lung
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: Up to 2 years
Year 2
Duration of response (DOR)
Year 2
Overall survival (OS)
Year 2
Progression-free survival (PFS)
Up to 2 years
Incidence of adverse events (expansion cohort)
Overall response rate (ORR)
Day 21
Maximum tolerated dose (MTD) (dose-escalation cohort)
Trial Safety
Safety Progress
Side Effects for
Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
Trial Design
1 Treatment Group
Treatment (tazemetostat, pembrolizumab, topotecan)
1 of 1
Experimental Treatment
60 Total Participants · 1 Treatment Group
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1
Treatment (tazemetostat, pembrolizumab, topotecan)Experimental Group · 5 Interventions: Biopsy, Biospecimen Collection, Topotecan Hydrochloride, Pembrolizumab, Tazemetostat Hydrobromide · Intervention Types: Procedure, Procedure, Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120
Biospecimen Collection
2004
Completed Phase 1
~670
Topotecan Hydrochloride
2013
Completed Phase 3
~6100
Pembrolizumab
2017
Completed Phase 3
~2580
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,298,828 Total Patients Enrolled
Anish ThomasPrincipal InvestigatorNational Cancer Institute LAO
1 Previous Clinical Trials
98 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:Patients must have limited- or extensive-disease SCLC at diagnosis, with relapse at study entry with measurable disease per RECIST 1.1, and with prior therapy with platinum doublet.
Children under 18 years of age are excluded from this study.
Leukocytes > 3000/mcL.
Creatinine =< 1.5 institutional ULN OR GFR > 60 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.
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