Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Recurrent Small Cell Lung Cancer and Relapsed Small Cell Lung Cancer, sponsored by VA Office of Research and Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
According to response evaluation criteria in solid tumors RECIST 1.1(imaging criteria or progression or patient death).
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 |
What NCT06681220 shows while recruiting
NCT06681220 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, above the 26-participant average among 5 other Recurrent Small Cell Lung Cancer trials with a reported enrollment target (538% higher).
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 lists 11 locations in 10 states (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.
Learn More About Clinical Trials
Similar trials for Recurrent Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
CPI-613 in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
COMPLETED · Phase 1
-
Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors
COMPLETED · Phase 1
-
R-(-)-Gossypol Acetic Acid in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
COMPLETED · Phase 2
-
Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer
COMPLETED · Phase 2
-
Romidepsin in Treating Patients With Relapsed Small Cell Lung Cancer
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02747303 · 166 participants · Phase 2
Frameless Stereotactic Radiosurgery for Intact Brain Metastases
- NCT03806283 · 166 participants
Mechanisms of Pregnancy Vascular Adaptations
- NCT04040452 · 166 participants · Phase 4
Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
- NCT04375813 · 166 participants · Phase 2
Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI