Inclusion Criteria | |
• Histologically or cytologically confirmed SCLC • ES-SCLC that is not amenable to surgery or curative irradiation • No prior chemotherapy for SCLC • ECOG PS of 2 or 3 • Age 20 years or older at the time of consent • Patients with measurable lesions that are target lesions according to the RECIST version 1.1 • Adequate organ function • Neutrophil count: 1500/mm3 or more • Hemoglobin: 9.0 g/dL or more • Platelet count: 10.0 × 104/mm3 or more • AST: 2.5 times or less the upper limit of the institutional standard (5 times or less the upper limit of the institutional standard in the case of liver metastasis) • ALT: 2.5 times or less the upper limit of the institutional reference value (5 times or less the upper limit of the institutional reference value if liver metastases are present) • Total bilirubin: 1.5 times or less the upper limit of the institutional standard (3 times or less in the case of indirect hyperbilirubinemia such as Gilbert’s syndrome) • SpO2 93% or higher (or PaO2 70 Torr or higher) • Serum creatinine: less than 1.5 mg/dL (or creatinine clearance 45 mL/min or more) • Written informed consent | |
Exclusion Criteria | |
• Patients with a usual interstitial pneumonia (UIP) pattern or probable UIP pattern on chest CT • Patients with meningeal carcinomatosis • Patients with a history of radiation to the primary lesion • Patients with pleural effusion, pericardial effusion, or ascites requiring drainage • Patients with coexisting autoimmune diseases (myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, Sjogren’s syndrome, multiple sclerosis, etc.) • Patients with serious complications (active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, fatal arrhythmia, respiratory, hepatic or renal disease, etc.) • Patients with concurrent multiple cancers or heterogeneous multiple cancers with a disease-free interval of 5 years or less • Other patients who are judged by the principal investigator or subinvestigator to be inappropriate for participation in this study |