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NCT06681220 · ClinicalTrials.gov registry record · Phase 1

Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC

A Phase 1 study of Recurrent Small Cell Lung Cancer and Relapsed Small Cell Lung Cancer, sponsored by VA Office of Research and Development.

Recruiting
Registry status
Phase 1
Development phase
166
Enrollment target
11
Study locations

NCT06681220 is a Phase 1 study of Recurrent Small Cell Lung Cancer and Relapsed Small Cell Lung Cancer that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 166 participants, above the 26-participant average among 5 other Recurrent Small Cell Lung Cancer trials with a reported enrollment target (538% higher). The trial reports 11 study locations across 10 states.

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The verdict

NCT06681220, a Phase 1 study of Recurrent Small Cell Lung Cancer and Relapsed Small Cell Lung Cancer, is actively recruiting participants, sponsored by VA Office of Research and Development.

RECRUITING
Registry status
Phase 1
Development phase
166 participants
Enrollment target
11
Study locations

Study Summary

Randomized phase 2, multicenter, biomarker directed clinical trial with a safety lead-in to assess the efficacy of Stenoparib plus Temozolomide (TMZ) in relapsed Small Cell Lung Cancer patients. Participants will receive either a combination of oral Stenoparib at the highest tolerated dose with oral Temozolomide 40mg daily or standard of care Lurbinectedin for 21-day cycles. The Dose limiting toxicity period will be 1 cycle of 21 days. This study will explore if the biomarkers the investigators test predict sensitivity to the combination of Stenoparib plus TMZ and therefore leads to a better treatment response. There are two potential tests of biomarkers that can predict who would benefit from the oral combination of Stenoparib with Temozolomide (TMZ), but they have not been evaluated. This study will test for this sensitivity using a biomarker (found in the blood that may be related to how a person reacts to a drug). The study will include 9 participants for the safety evaluation of the Stenoparib+TMZ group and 5 participants for the standard of care Lurbinectedin safety group. We will first determine safety dose for the experiment arm which, will include 3 groups with 3 participants in each group. Three doses of Stenoparib will be evaluated for toxicity. The initial starting dose of Stenoparib will be 200mg po QD. Once the maximum tolerated dose has been determined, participants will be assigned to one of the two groups in the phase 2 portion. Group 1 will be patients that test negative for the biomarker and will receive treatment with Lurbinectedin as per standard of care guidelines. Group 2 will be patients that test positive for the biomarker that will be randomly assigned to either the combination of Stenoparib plus Temozolomide (TMZ) or Lurbinectedin.

Conditions Studied

Recurrent Small Cell Lung Cancer Relapsed Small Cell Lung Cancer

Interventions

  • COMBINATION_PRODUCT Stenoparib/Temozolomide
  • DRUG Lurbinectedin

Study Locations (11)

Pennsylvania

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA - Philadelphia
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA - Pittsburgh

California

  • VA Palo Alto Health Care System, Palo Alto, CA - Palo Alto

Illinois

  • Jesse Brown VA Medical Center, Chicago, IL - Chicago

Indiana

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN - Indianapolis

Kentucky

  • Robley Rex VA Medical Center, Louisville, KY - Louisville

Michigan

  • VA Ann Arbor Healthcare System, Ann Arbor, MI - Ann Arbor

Minnesota

  • Minneapolis VA Health Care System, Minneapolis, MN - Minneapolis

Nebraska

  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE - Omaha

Trial Details

FieldValue
Enrollment Target 166 participants
Start Date 2026-02-23
Est. Completion 2030-12-31
Phase Phase 1

Sponsor

VA Office of Research and Development

1,668 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06681220

The ClinicalTrials.gov registry entry for NCT06681220 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 26-participant average among 5 other Recurrent Small Cell Lung Cancer trials with a reported enrollment target (538% higher). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Recurrent Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Stenoparib/Temozolomide is the first listed.

NCT06681220 reports 11 study locations spanning 10 distinct geographic areas - top geographies include Pennsylvania, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT06681220 about?

NCT06681220 is a clinical study titled "Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC". Randomized phase 2, multicenter, biomarker directed clinical trial with a safety lead-in to assess the efficacy of Stenoparib plus Temozolomide (TMZ) in relapsed Small Cell Lung Cancer patients. Participants will receive either a combination of oral Stenoparib at the highest tolerated dose with oral...

What is the current status of trial NCT06681220?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 166 participants. The study started on 2026-02-23. Estimated completion is 2030-12-31.

What conditions does trial NCT06681220 study?

This clinical trial studies the following conditions: Recurrent Small Cell Lung Cancer, Relapsed Small Cell Lung Cancer.

What interventions are being tested in trial NCT06681220?

The interventions under investigation include: Stenoparib/Temozolomide (COMBINATION_PRODUCT), Lurbinectedin (DRUG).

Who is sponsoring clinical trial NCT06681220?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06681220 being conducted?

This trial has 11 study locations across California, Illinois, Indiana, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.