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NCT05353439 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
18
Enrollment target
15
Study locations

NCT05353439 is a Phase 1 study of Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 151-participant average among 16 other Extensive Stage Lung Small Cell Carcinoma trials with a reported enrollment target (88% lower). The trial reports 15 study locations across 8 states.

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The verdict

NCT05353439, a Phase 1 study of Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
18 participants
Enrollment target
15
Study locations

Study Summary

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.

Interventions

  • BIOLOGICAL Pembrolizumab
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy Procedure
  • DRUG Tazemetostat Hydrobromide

Study Locations (15)

California

  • Keck Medicine of USC Koreatown - Los Angeles
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • USC Norris Oncology/Hematology-Newport Beach - Newport Beach
  • University of California Davis Comprehensive Cancer Center - Sacramento

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
  • NCI - Center for Cancer Research - Bethesda

New York

  • Montefiore Medical Center-Einstein Campus - The Bronx
  • Montefiore Medical Center - Moses Campus - The Bronx

North Carolina

  • Wake Forest University at Clemmons - Clemmons
  • Wake Forest University Health Sciences - Winston-Salem

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Illinois

  • Northwestern University - Chicago

Kentucky

  • University of Kentucky/Markey Cancer Center - Lexington

Texas

  • UT Southwestern/Simmons Cancer Center-Dallas - Dallas

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2022-07-27
Est. Completion 2027-03-13
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT05353439

The ClinicalTrials.gov registry entry for NCT05353439 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 151-participant average among 16 other Extensive Stage Lung Small Cell Carcinoma trials with a reported enrollment target (88% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Extensive Stage Lung Small Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT05353439 reports 15 study locations spanning 8 distinct geographic areas - top geographies include California, Maryland, New York.

Frequently Asked Questions

What is clinical trial NCT05353439 about?

NCT05353439 is a clinical study titled "Testing of Tazemetostat in Combination With Topotecan and Pembrolizumab in Patients With Recurrent Small Cell Lung Cancer". 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 ...

What is the current status of trial NCT05353439?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2022-07-27. Estimated completion is 2027-03-13.

What conditions does trial NCT05353439 study?

This clinical trial studies the following conditions: Extensive Stage Lung Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma, Limited Stage Lung Small Cell Carcinoma, Platinum-Resistant Lung Small Cell Carcinoma, Platinum-Sensitive Lung Small Cell Carcinoma.

What interventions are being tested in trial NCT05353439?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Tazemetostat Hydrobromide (DRUG).

Who is sponsoring clinical trial NCT05353439?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05353439 being conducted?

This trial has 15 study locations across California, District of Columbia, Illinois, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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