NCT06681220 Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC
| NCT ID | NCT06681220 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Relapsed Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 166 participants in total. It began in 2026-02-23 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older at the time of consent. * Histological or cytological diagnosis of extensive-stage small cell lung cancer. * Patients must have received one prior line of systemic therapy. * Patients must have received first-line therapy with Carboplatin and Etoposide. * If patient is re-treated with Carboplatin and Etoposide at least 6 months or more after first regimen, this will still be considered one line of * treatment and they will qualify for this trial. * Patients could have received immunotherapy in combination with the chemotherapy regimen. * Patients who have received Tarlatamab as second line treatment are allowed. * ECOG Performance status 0-2. * Measurable disease as per RECIST v1.1 (NOTE: Previously irradiated lesions are eligible as a target lesion only if there is documented progression of the lesion after irradiation). * Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements: * ANC 1.5 * Platelets 100 × 109/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. * Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test within 72 hours of cycle 1 Day 1. * Male and female subjects of child-bearing potential must agree to use a double-barrier method of birth control from the screening visit through 180 days after the last dose of study drug. * Male subjects of child-bearing potential must agree to use a double-barrier method of birth control including use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) and must agree to refrain from donating sperm from screening visit through at least 90 days after the last dose of study drug. * Previously treated or asymptomatic brain metastases are allowed. Exclusion Criteria: * Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol. * Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy. (Suppressive therapy for chronic infections allowed, for example: Subjects with HIV/AIDS with adequate antiviral therapy to control viral load would be allowed. Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy.) * Prior exposure to lurbinectedin, TMZ or stenoparib. * Pregnant or breastfeeding. * Clinical significant cardiovascular disease (ie active) * Subject with known hypersensitivity to Stenoparib components * Subject with known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) are excluded. * Subject with QTc interval 470 for females, or 450 for males per electrocardiogram (EKG) at screening.
Contact & Investigator
Shadia Jalal, MD
PRINCIPAL INVESTIGATOR
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Frequently Asked Questions
Who can join the NCT06681220 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06681220 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06681220 currently recruiting?
Yes, NCT06681220 is actively recruiting participants. Contact the research team at Shadia.Jalal@va.gov for enrollment information.
Where is the NCT06681220 trial being conducted?
This trial is being conducted at Palo Alto, United States, Chicago, United States, Indianapolis, United States, Louisville, United States and 7 additional locations.
Who is sponsoring the NCT06681220 clinical trial?
NCT06681220 is sponsored by VA Office of Research and Development. The principal investigator is Shadia Jalal, MD at Richard L. Roudebush VA Medical Center, Indianapolis, IN. The trial plans to enroll 166 participants.
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