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Active, not recruiting Phase 1 Interventional

Testing of Tazemetostat in Combination With Topotecan and Pembrolizumab in Patients With Recurrent Small Cell Lung Cancer

ClinicalTrials.gov ID: NCT05353439

Public ClinicalTrials.gov record NCT05353439. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 2:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I Dose Escalation and Expansion Study of Tazemetostat in Combination With Topotecan and Pembrolizumab in Recurrent Small Cell Lung Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase I trial tests the safety, side effects, and best dose of tazemetostat in combination with topotecan and pembrolizumab in treating patients with small cell lung cancer that has come back after a period of improvement (recurrent). Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tazemetostat in combination with topotecan and pembrolizumab may shrink or stabilize recurrent small cell lung cancer.

Study identification

NCT ID
NCT05353439
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Enrollment
18 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 26, 2022
Primary completion
Feb 10, 2026
Completion
Mar 12, 2027
Last update posted
May 12, 2026

2022 – 2027

United States locations

U.S. sites
15
U.S. states
8
U.S. cities
12
Facility City State ZIP Site status
Keck Medicine of USC Koreatown Los Angeles California 90020
Los Angeles General Medical Center Los Angeles California 90033
USC / Norris Comprehensive Cancer Center Los Angeles California 90033
USC Norris Oncology/Hematology-Newport Beach Newport Beach California 92663
University of California Davis Comprehensive Cancer Center Sacramento California 95817
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007
Northwestern University Chicago Illinois 60611
University of Kentucky/Markey Cancer Center Lexington Kentucky 40536
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287
NCI - Center for Cancer Research Bethesda Maryland 20892
Montefiore Medical Center-Einstein Campus The Bronx New York 10461
Montefiore Medical Center - Moses Campus The Bronx New York 10467
Wake Forest University at Clemmons Clemmons North Carolina 27012
Wake Forest University Health Sciences Winston-Salem North Carolina 27157
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05353439, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 12, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05353439 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →