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Table 2 Additional inclusion and exclusion criteria in the second registration

From: A phase II study of daily carboplatin plus irradiation followed by durvalumab for stage III non-small cell lung cancer patients with PS 2 up to 74 years old and patients with PS 0 or 1 from 75 years: NEJ039A (trial in progress)

Inclusion criteria
 1 Completion of thoracic irradiation with more than total 40 Gy
 2 Daily carboplatin with more than 10 day
 3 Non-PD and PS 0, 1 or 2 after chemoradiotherapy
 4 Normal main organ functions in the following values; Absolute neutrophil count > 1500/mm3, Platelet count ≥100,000/mm3, Hemoglobin ≥9.0 g/dl, AST, ALT ≤2.5 times ULN if no demonstrable liver metastases or ≤ 5 times ULN in the presence of liver metastases, Total bilirubin ≤1.5 times ULN if no liver metastases or ≤ 3 times ULN in the presence of documented Gilbert’s Syndrome [unconjugated hyperbilirubinaemia] or liver metastases, Creatinine within the normal value in each institution, PaO2 or SpO2 ≥ 70 Torr or ≥ 95%
Exclusion criteria
 1 Patients with locally advanced NSCLC who have progressed whilst radiotherapy concurrent with daily carboplatin
 2 Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy
 3 Patients with any grade pneumonitis from prior chemoradiation therapy
 4 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
 5 Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving Durvalumab
 6 Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of Durvalumab.
  1. Abbreviation: PD progressive disease; PS performance status; AST,; ALT,; NSCLC, non-small cell lung cancer; CTCAE,