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Table 1 Key patient eligibility criteria

From: A phase II study of carboplatin and etoposide plus durvalumab for previously untreated extensive-stage small-cell lung cancer (ES-SCLC) patients with a poor performance status (PS): NEJ045A study protocol

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

  1. Abbreviations: ES-SCLC Extensive-stage small-cell lung cancer, ECOG Eastern Cooperative Oncology Group, PS Performance status, RECIST Response Evaluation Criteria in Solid Tumors, AST Aspartate aminotransferase, ALT Alanine aminotransferase, SpO2 Percutaneous oxygen saturation, PaO2 Partial pressure of arterial oxygen, CT Computed tomography