New combo aims to outsmart relapsed lung cancer
NCT ID NCT06681220
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new combination of two oral drugs, Stenoparib and Temozolomide, in people whose small cell lung cancer has returned after initial treatment. The trial uses a blood test (biomarker) to see who might benefit most from the combo, comparing it to the standard drug Lurbinectedin. About 166 participants will take part to first find the safest dose, then see if the combo improves outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stenoparib and Temozolomide combination
- What this could lead to
- If successful, this could offer a new, biomarker-guided treatment option for people with relapsed small cell lung cancer, potentially improving how long they live without their cancer growing.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with a small number of participants, so the benefits are uncertain. The drug combination may cause side effects or may not work better than the current standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 166 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
RECRUITINGPhiladelphia, Pennsylvania, 19104-4551, United States
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Jesse Brown VA Medical Center, Chicago, IL
NOT_YET_RECRUITINGChicago, Illinois, 60612, United States
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Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITINGHouston, Texas, 77030-4211, United States
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Minneapolis VA Health Care System, Minneapolis, MN
NOT_YET_RECRUITINGMinneapolis, Minnesota, 55417-2309, United States
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Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
NOT_YET_RECRUITINGOmaha, Nebraska, 68105-1850, United States
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Richard L. Roudebush VA Medical Center, Indianapolis, IN
RECRUITINGIndianapolis, Indiana, 46202-2884, United States
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Robley Rex VA Medical Center, Louisville, KY
NOT_YET_RECRUITINGLouisville, Kentucky, 40206-1433, United States
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Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
RECRUITINGSalisbury, North Carolina, 28144, United States
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VA Ann Arbor Healthcare System, Ann Arbor, MI
NOT_YET_RECRUITINGAnn Arbor, Michigan, 48105-2303, United States
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VA Palo Alto Health Care System, Palo Alto, CA
RECRUITINGPalo Alto, California, 94304-1207, United States
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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
RECRUITINGPittsburgh, Pennsylvania, 15240, United States
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