Phase I Study of Valemetostat and Atezolizumab as Maintenance Therapy for Patients With Extensive-Stage Small Cell Lung Cancer
This study will test whether valemetostat in combination with atezolizumab is a safe treatment that causes few or mild side effects in people with extensive-stage small cell lung cancer (SCLC). The researchers will test different doses of valemetostat to find the highest dose that causes few or mild side effects in participants. After the dose is found, researchers will test it in a new group of participants to learn more about the safety of the study treatment and see if it is an effective treatment for extensive-stage SCLC.
• Signed informed consent form (ICF)
• Ability to comply with the study protocol as per the investigator's judgment
• Age ≥ 18 years at the time of signing the ICF
• Life expectancy ≥ 12 weeks
• ECOG performance status 0 or 1
• Pathologically confirmed diagnosis of newly diagnosed extensive-stage small cell lung cancer. Patients with a diagnosis of combined small cell lung cancer with other histologies may be considered for inclusion if the predominant histology is SCLC and only after discussion with the study PI.
• Radiographically documented RECIST version 1.1 stable disease, partial or complete response after initial treatment with a platinum doublet regimen in combination with atezolizumab for 4 cycles. It is acceptable to have no measurable disease at the start of this study.
• Must be able to begin therapy within 4 weeks of completing the fourth cycle of chemotherapy and immunotherapy.
• Adequate hematologic and end-organ function, as defined by the following laboratory test results obtained within 14 days prior to initiation of study treatment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to screening laboratory tests:
• o Adequate bone marrow function as defined by:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (1500/µL)
• Hemoglobin ≥ 9 g/dL
• Platelets ≥ 100 x 10\^9/L o Adequate renal function as defined by:
• Creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft-Gault equation
• o Adequate hepatic function as defined by:
• AST, ALT, and alkaline phosphatase (ALP) ≤ 3 x ULN with the following exception:
• Patients with documented liver metastases: AST, ALT and ALP ≤ 5 x ULN