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Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC
NCT06681220 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2026-02-23 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 1 |
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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. It is categorized as Phase 1, 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 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT06681220 reports 11 study locations spanning 10 distinct geographic areas — top geographies include Pennsylvania, California, Illinois. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06681220?
The interventions under investigation include: Stenoparib/Temozolomide (COMBINATION_PRODUCT), Lurbinectedin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06681220?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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