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Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs
NCT03896503 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03896503
The ClinicalTrials.gov registry entry for NCT03896503 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03896503 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Kansas, California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03896503?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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