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New combo aims to outsmart relapsed lung cancer

NCT ID NCT06681220

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 166 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    RECRUITING

    Philadelphia, Pennsylvania, 19104-4551, United States

  • Jesse Brown VA Medical Center, Chicago, IL

    NOT_YET_RECRUITING

    Chicago, Illinois, 60612, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    RECRUITING

    Houston, Texas, 77030-4211, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55417-2309, United States

  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68105-1850, United States

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    RECRUITING

    Indianapolis, Indiana, 46202-2884, United States

  • Robley Rex VA Medical Center, Louisville, KY

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40206-1433, United States

  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

    RECRUITING

    Salisbury, North Carolina, 28144, United States

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48105-2303, United States

  • VA Palo Alto Health Care System, Palo Alto, CA

    RECRUITING

    Palo Alto, California, 94304-1207, United States

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    RECRUITING

    Pittsburgh, Pennsylvania, 15240, United States

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