Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT06681220
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06681220
Study Brief:
Protocol Section:
NCT06681220