Guadecitabine and Carboplatin in Treating Patients with Extensive Stage Small Cell Lung Cancer

Inclusion Criteria

• Histological or cytological diagnosis of small cell lung cancer. Subjects must have extensive stage disease, defined as disease beyond the ipsilateral hemithorax, mediastinum and ipsilateral supraclavicular area and including malignant pleural or pericardial effusion or hematogenous metastases
• Patients must have received first line therapy with a platinum-based chemotherapy. Patients should not have received more than 1 prior line of chemotherapy (could have received immunotherapy which does not count as chemotherapy)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
• Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version(v)1.1. Subjects may have bone-only disease. * NOTE: Bone-only subjects are eligible if their disease can be documented/evaluated by bone scans, computed tomography (CT) or magnetic resonance imaging (MRI). Their disease will be assessed using MD Anderson criteria. * NOTE: Previously irradiated lesions are eligible as a target lesion only if there is documented progression of the lesion after irradiation
• Hemoglobin >= 9.0 g/dL
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• Total bilirubin =< 1.5 x upper limit of normal (ULN). For subjects with Gilbert’s disease, total bilirubin =< 3 x ULN
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN. For subjects with documented liver metastases, ALT and AST =< 5 x ULN
• Estimated glomerular filtration rate (eGFR) >= 60 mL/minute/1.73 m^2 as determined using the Cockcroft-Gault formula
• Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening
• Male and female subjects of child-bearing potential must agree to use contraception from the screening visit through 6 months after the last dose of study drug

Exclusion Criteria

• Platinum refractory disease defined as disease progression during first line platinum containing chemotherapy regimen. Progression following platinum based therapy is allowed
• Prior therapy with a hypomethylating agent
• Previously untreated (non-irradiated), symptomatic brain metastases. No prior treatment is required for non-symptomatic brain metastases. Previously treated symptomatic brain metastases are permitted
• 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 human immunodeficiency virus [HIV]/acquired immunodeficiency syndrome [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)
• Hypersensitivity to (IMP) or components of the study treatment regimen
• Treated with any investigational drug within 3 weeks of first dose of study treatment
• Pregnant or breastfeeding
• Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy