OncoMatch/Clinical Trials/NCT06681220
Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC
Is NCT06681220 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Stenoparib/Temozolomide and Lurbinectedin for relapsed small cell lung cancer.
Treatment: Stenoparib/Temozolomide · Lurbinectedin · Stenoparib/Temozolomide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Disease stage
Required: Stage IV
Measurable disease as per RECIST v1.1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy (carboplatin, etoposide) — first-line
Patients must have received first-line therapy with Carboplatin and Etoposide.
Cannot have received: lurbinectedin
Prior exposure to lurbinectedin
Cannot have received: alkylating agent (temozolomide)
Prior exposure to TMZ
Cannot have received: PARP inhibitor (stenoparib)
Prior exposure to stenoparib
Lab requirements
Blood counts
ANC 1.5; Platelets 100 × 10^9/L; Hemoglobin 9 g/dL or 5.6 mmol/L
Kidney function
Creatinine <1.5 × ULN or estimated glomerular filtration rate (GFR) 50 ml/min by Cockcroft-Gault. Depending on scenario, GFR 30-49 can be permissible.
Liver function
Aspartate transaminase and alanine transaminase 2.5 × upper limit of normal (ULN), <5× in patients with known liver metastases; Serum total bilirubin 1.5 × ULN, 1.5-3.0 × ULN may be included with appropriate starting dose adjustment to 200 mg daily.
Cardiac function
QTc interval 470 for females, or 450 for males per electrocardiogram (EKG) at screening.
Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements: ANC 1.5; Platelets 100 × 10^9/L; Hemoglobin 9 g/dL or 5.6 mmol/L; Aspartate transaminase and alanine transaminase 2.5 × upper limit of normal (ULN), <5× in patients with known liver metastases; Serum total bilirubin 1.5 × ULN, 1.5-3.0 × ULN may be included appropriate starting dose adjustment to 200 mg daily. Creatinine <1.5 × ULN or estimated glomerular filtration rate (GFR) 50 ml/min by Cockcroft-Gault. Depending on scenario, GFR 30-49 can be permissible. QTc interval 470 for females, or 450 for males per electrocardiogram (EKG) at screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- VA Palo Alto Health Care System, Palo Alto, CA · Palo Alto, California
- Jesse Brown VA Medical Center, Chicago, IL · Chicago, Illinois
- Richard L. Roudebush VA Medical Center, Indianapolis, IN · Indianapolis, Indiana
- Robley Rex VA Medical Center, Louisville, KY · Louisville, Kentucky
- VA Ann Arbor Healthcare System, Ann Arbor, MI · Ann Arbor, Michigan
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