Pembrolizumab for Small cell carcinoma of lung

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Small cell carcinoma of lung+6 More
Pembrolizumab - Biological
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

1 of 3

Other trials for Small cell carcinoma of lung

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

1 of 3

Other trials for Small cell carcinoma of lung

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

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 preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

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.