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NCT03896503 · ClinicalTrials.gov registry record · Phase 2
Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs
A Phase 2 study of Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
- 20
- Study locations
NCT03896503: Active Phase 2 study of Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03896503 is a Phase 2 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 104 participants, below the 145-participant average among 16 other Extensive Stage Lung Small Cell Carcinoma trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03896503, a Phase 2 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 2
- Development phase
- 104 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well berzosertib (M6620) works when given in combination with topotecan hydrochloride (topotecan) compared with topotecan alone in treating patients with small cell lung cancer that has come back (relapsed), or small cell cancer that arises from a site other than the lung (extrapulmonary). Drugs used in chemotherapy, such as topotecan hydrochloride, work by damaging the DNA (deoxyribonucleic acid) in tumor cells, causing those cells to die and the tumor to shrink. However, some tumor cells can become less affected by chemotherapy because they have ways to repair the damaged DNA. The addition of M6620 could help topotecan hydrochloride shrink the cancer and prevent it from returning by blocking enzymes needed for DNA repair.
Primary Outcome
The combination of M6620 with topotecan will be compared to topotecan alone in participants with relapsed small cell lung cancer (SCLC). Kaplan-Meier curves and a one-tailed log-rank test will be the primary analysis methods. PFS is defined as the duration of time from start of treatment to time of progression or death. whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and is at least a 20% increase in the sum of
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- DRUG Berzosertib
- DRUG Topotecan Hydrochloride
Study Locations (20)
Kansas
- University of Kansas Clinical Research Center - Fairway
- HaysMed - Hays
- University of Kansas Cancer Center - Kansas City
- Lawrence Memorial Hospital - Lawrence
- The University of Kansas Cancer Center - Olathe - Olathe
- University of Kansas Cancer Center-Overland Park - Overland Park
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- Mercy Hospital Pittsburg - Pittsburg
- Salina Regional Health Center - Salina
- University of Kansas Health System Saint Francis Campus - Topeka
- University of Kansas Hospital-Westwood Cancer Center - Westwood
California
- 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
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
- Weisberg Cancer Treatment Center - Farmington Hills
Colorado
- UCHealth University of Colorado Hospital - Aurora
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Maryland
- NCI - Center for Cancer Research - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2019-12-30 |
| Est. Completion | 2026-06-23 |
| Phase | Phase 2 |
What the registry record for NCT03896503 still lists
NCT03896503 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 145-participant average among 16 other Extensive Stage Lung Small Cell Carcinoma trials with a reported enrollment target (28% 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 Biospecimen Collection is the first listed.
NCT03896503 names 20 study sites across 6 states, led by Kansas, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT03896503 about?
NCT03896503 is a clinical study titled "Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs". This phase II trial studies how well berzosertib (M6620) works when given in combination with topotecan hydrochloride (topotecan) compared with topotecan alone in treating patients with small cell lung cancer that has come back (relapsed), or small cell cancer that arises from a site other than the ...
What is the current status of trial NCT03896503?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2019-12-30. Estimated completion is 2026-06-23.
What conditions does trial NCT03896503 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 NCT03896503?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Berzosertib (DRUG), Topotecan Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03896503?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03896503 being conducted?
This trial has 20 study locations across California, Colorado, Kansas, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03896503's enrollment target sits among peer trials
104 5th of 16 higher than 12 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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