Actively Recruiting
Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC
Led by VA Office of Research and Development · Updated on 2026-03-11
166
Participants Needed
11
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Histological or cytological diagnosis of extensive-stage small cell lung cancer
- Received one prior line of systemic therapy including first-line Carboplatin and Etoposide
- Prior immunotherapy with chemotherapy allowed
- Prior Tarlatamab as second line treatment allowed
- ECOG performance status 0 to 2
- Measurable disease by RECIST v1.1 criteria
- Adequate bone marrow, liver, and kidney function meeting specific laboratory requirements
- Women of child-bearing potential must have negative pregnancy test within 72 hours before treatment
- Both male and female subjects of child-bearing potential must agree to use double-barrier birth control through 180 days after last dose
- Male subjects must agree to use condom and avoid sperm donation through 90 days after last dose
- Previously treated or asymptomatic brain metastases are allowed
You will not qualify if you...
- Unstable or significant medical, psychiatric, or social conditions that risk safety or protocol compliance
- Acute infection requiring systemic antibacterial, antifungal, or antiviral therapy (chronic suppressive therapy allowed)
- Prior exposure to Lurbinectedin, Temozolomide, or Stenoparib
- Pregnant or breastfeeding
- Active clinically significant cardiovascular disease
- Known hypersensitivity to Stenoparib components
- History of myelodysplastic syndrome or acute myeloid leukemia
- QTc interval greater than 470 ms for females or 450 ms for males on screening EKG
AI-Screening
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Trial Site Locations
Total: 11 locations
1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
Actively Recruiting
2
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
Not Yet Recruiting
3
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Actively Recruiting
4
Robley Rex VA Medical Center, Louisville, KY
Louisville, Kentucky, United States, 40206-1433
Not Yet Recruiting
5
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
Not Yet Recruiting
6
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309
Not Yet Recruiting
7
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States, 68105-1850
Not Yet Recruiting
8
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, United States, 28144
Actively Recruiting
9
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104-4551
Actively Recruiting
10
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Actively Recruiting
11
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
Research Team
S
Shadia Jalal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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