Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Nov 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with relapsed Small Cell Lung Cancer (SCLC), a type of lung cancer that can come back after initial treatment. Researchers want to see if a combination of two medications, a PARP inhibitor (Niraparib) and Temozolomide (TMZ), can help patients whose cancer has returned. They will test for specific markers in the blood that may indicate which patients are more likely to benefit from this combination treatment. Patients will be grouped based on these test results: those who test positive for the marker will have a chance to receive the new combination therapy, while those who test negative will continue with standard care using another drug called Lurbinectedin.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of extensive-stage SCLC, meaning the cancer has spread beyond its original location. They should have already received one line of treatment, typically a combination of Carboplatin and Etoposide, and should have measurable disease. The trial is currently not recruiting participants, but once it starts, it aims to provide valuable insights into more effective treatment options for relapsed SCLC. Participants can expect to undergo tests to check their eligibility and monitor their health throughout the study. Importantly, those who are pregnant or breastfeeding, or have certain health conditions, may not qualify for this trial.

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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.