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Phase 2 Study of Stenoparib and Temozolomide for Relapsed Small Cell Lung Cancer

This study is testing a new combination treatment, Stenoparib and Temozolomide, for people with small cell lung cancer that has come back (relapsed). You might receive this combination or a standard treatment called Lurbinectedin. The study aims to see how well the Stenoparib and Temozolomide combination works and if certain markers in your body can predict who will respond best to it. To join, you must be 18 or older, have extensive-stage small cell lung cancer, and have already received one prior treatment with Carboplatin and Etoposide. The main goals are to see how long people live without their cancer getting worse (Progression Free Survival) and to find the safest dose of Stenoparib.

Study design
This is a randomized phase 2 study with a safety lead-in, aiming to enroll 166 participants. It compares a combination treatment to a standard treatment.
What's involved
Participants will receive treatments in 21-day cycles. The initial safety evaluation period for the Stenoparib and Temozolomide group is one 21-day cycle.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Progression Free Survival through study completion, up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06681220

Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC

Recruiting
PHASE1Ages 18+InterventionalTreatment
VA Office of Research and Development
~166 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:Stenoparib/TemozolomideLurbinectedin

At a glance

Recruiting sites
6 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over Through study completion up to 2 years.
+1 more outcome measured

Conditions

Relapsed Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer

Explore related trials

Lung Small Cell Carcinoma

Where it's being run

11 sites across 10 states
Pennsylvania2
California1
Illinois1
Indiana1
Kentucky1
Michigan1
Minnesota1
Nebraska1

Study leadership

  • Shadia Jalal, MD · PRINCIPAL_INVESTIGATOR · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Who to contact

Shadia Jalal, MD
[email protected]
(317) 274-5500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression Free Survival (PFS)Through study completion up to 2 years.

    According to response evaluation criteria in solid tumors RECIST 1.1(imaging criteria or progression or patient death).

  • Recommended Phase 2 doseThrough end of cycle 1 (21 days)

    Defined as the recommended dose of Stenoparib for phase 2