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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 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.

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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.

Conditions Studied

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 Extrapulmonary Small Cell Neuroendocrine Carcinoma

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

FieldValue
Enrollment Target 104 participants
Start Date 2019-12-30
Est. Completion 2026-06-23
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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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, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 145-participant average among 16 other Extensive Stage Lung Small Cell Carcinoma trials with a reported enrollment target (28% 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 Biospecimen Collection is the first listed.

NCT03896503 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.