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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: Active Phase 1 study of Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-07-27 |
| Est. Completion | 2027-03-13 |
| Phase | Phase 1 |
What the registry record for NCT05353439 still lists
NCT05353439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 151-participant average among 16 other Extensive Stage Lung Small Cell Carcinoma trials with a reported enrollment target (88% lower).
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 lists 15 locations in 8 states (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.
Learn More About Clinical Trials
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Where NCT05353439's enrollment target sits among peer trials
18 14th of 16 higher than 2 of 16 other Extensive Stage Lung Small Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Extensive Stage Lung Small Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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