Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC

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.