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Table 1 Inclusion and exclusion criteria in the first 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  Patients with a diagnosis of non-small cell lung cancer (NSCLC) histologically or cytologically
2  Patients that are in stage IIIa, IIIb, or IIIc (UICC 8th version) and have indication for radical radiation therapy, but have no indication for surgical therapy.
3  No previous treatments.
4  Patients with measurable lesions that can be evaluated by RECIST (version1.1).
5  Patients without indication for concurrent chemoradiation using platinum doublet, namely, patients with ECOG PS 2 up to  74 years old, and patients with PS 0 or 1 from 75 years.
6  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%
7  Written informed consent must be given
Exclusion criteria
1  Past medical history of interstitial lung disease, drug-induced interstitial lung disease, or any evidence of clinically active interstitial lung disease
2  Contralateral hilar nodes, atelectasis of the entire lung, or malignant pleural or pericardial effusions
3  Patients with severe complications such as uncontrolled heart, lung, liver, or kidney disease or diabetes mellitus
4  Any of the following cardiac criteria: Patients must not enter the study if any of the following exclusion criteria are fulfilled: i) Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value, ii) Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block. iii) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.
5  Any evidence of active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
6  Patients with severe malabsorption syndrome or with disease affecting digestive function such as total gastrectomy or active inflammatory bowel disease
7  Patients that have received systemic administration of steroids at a dose of more than prednisolone10mg (or equivalent to this) for 4 weeks or longer
8  Besides the above-mentioned cases, those with contraindications for therapy with carboplatin
9  Patients with active double cancers other than intramucosal carcinoma
10  Mixed small cell and non-small cell lung cancer histology
11  Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. NOTE: Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable (eg, by local surgery or radiotherapy)
12  Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave ‘s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
13  Active or prior documented inflammatory bowel disease (eg, Crohn ‘s disease, ulcerative colitis)
14  History of primary immunodeficiency
15  History of organ transplant that requires therapeutic immunosuppression
16  History of another primary malignancy within 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study
17  Other cases that are determined to be inappropriate by attending physicians