Bomedemstat and Maintenance Immunotherapy for Treatment of Newly Diagnosed Extensive Stage Small Cell Lung Cancer

Exclusion Criteria

• •Prior receipt of systemic therapy for ES-SCLC other than four cycles of induction platinum-etoposide and immune checkpoint inhibitor
• •Diagnosis of LS-SCLC that has not been previously treated
• •Receipt of radiation therapy for symptomatic deterioration and/or radiographic disease progression that was administered after initiation of induction platinum-etoposide and immune checkpoint inhibitor. Note: the presence of untreated asymptomatic brain metastasis, or a history of receipt of radiation to brain metastasis that was not initiated in response to symptomatic deterioration and/or radiographic disease progression following initiation of induction systemic therapy, does not preclude study participation. Investigators should contact the PI if clarification is needed
• •Anticipated use of prophylactic cranial irradiation or consolidative thoracic radiation therapy during study participation. Note: Palliative radiation to the central nervous system (CNS) for new CNS disease that develops during study participation is allowed
• •History of prior immune-related adverse event or other toxicity associated with immune checkpoint inhibitor that precludes safe administration of maintenance atezolizumab, in the opinion of the investigator
• •Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion:
• •* Intranasal, inhaled, topical steroids or local steroid injections (e.g., intra-articular injection)
• •* Systemic corticosteroids at doses not to exceed 10 mg/d of prednisone or equivalent
• •* Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \[CT\] scan premedication)
• •Active autoimmune disease requiring systemic immunosuppression or history of autoimmune disease requiring systemic immunosuppression within the last 2 years
• •* Note: Systemic immunosuppression should be interpreted as systemic glucocorticoids at a dose of greater than 10 mg/day of prednisone or equivalent, systemic biologic agents including monoclonal antibodies against inflammatory mediators, or small molecule agents. Investigators should contact the PI if clarification is needed
• •Active pneumonitis or interstitial lung disease (ILD), or a history of pneumonitis/ILD, which required systemic immunosuppression (e.g. corticosteroids)
• •Known bleeding disorder (e.g., dysfibrinogenaemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation \[DIC\], fibrinogen deficiency, or other clotting factor deficiency), at the discretion of the investigator
• •History of severe thrombocytopenia or platelet dysfunction (e.g. immune thrombocytopenic purpura), at the discretion of the investigator
• •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or LSD1 inhibitors (i.e., monoamine oxidase inhibitors; MAOIs) that contraindicates their participation
• •Any hypersensitivity to PD-1/PD-L1 targeting agents
• •Current use of monoamine oxidase A and B inhibitors (MAOIs)
• •Current use of a prohibited medication (e.g. romiplostim) or expected to require any of these medications during treatment with the investigational drug
• •Current or anticipated use of an antiplatelet (e.g. clopidogrel), anticoagulant (e.g. warfarin or apixaban), or nonsteroidal anti-inflammatory drug (NSAID) with antiplatelet activity (e.g. aspirin, ibuprofen), that, in the opinion of the investigator, could NOT be safely discontinued when the subject's platelet count decreases below 50 x 10\^3/mcL
• •Has undergone major surgery within 4 weeks prior to starting study drug and/or has not recovered from side effects of such surgery. Note: Major surgery and recovery are defined at the discretion of the investigator
• •Receipt of a live vaccine within 30 days of first dose of study therapy
• •Uncontrolled active infection
• •Any concomitant active malignancy considered clinically significant by the investigator
• •Known human immunodeficiency virus (HIV) infection or known active hepatitis B or hepatitis C virus infection (testing will not be conducted as part of screening procedures)
• •History of any illness/impairment of gastrointestinal (GI) function that might interfere with drug absorption (e.g. chronic diarrhea), confound the study results or pose an additional risk to the patient by participation in the study
• •Use of an investigational agent within 28 days, or the equivalent of at least 7 half-lives of that agent, whichever is the shorter, prior to the study day 1
• •Females who are pregnant or breastfeeding or plan to become pregnant or breastfeed at any time during the study