Inclusion criteria | |
---|---|
1 | Histologically or cytologically proven NSCLC |
2 | NSCLC with sensitizing EGFR mutations (exon 18 G719X, exon 19 deletions, exon 21 L858R, and exon 21 L861Q) |
3 | Unresectable NSCLC with stage III/IV cancer or postoperative recurrence |
4 | Age 20 years or older |
5 | ECOG PS 2–4 owing to NSCLC and life expectancy of more than 12 weeks |
6 | At least one measurable lesion according to RECIST version 1.1 |
7 | No prior cytotoxic chemotherapy, immune-checkpoint inhibitor, or targeted agent, including EGFR-tyrosine kinase inhibitor |
8 | Adequate laboratory data within 14 days before registration |
a) Neutrophil count ≥1500/mm3 | |
b) Hemoglobin ≥9.0 g/dL | |
c) Platelet count ≥100,000/mm3 | |
d) Aspartate aminotransferase ≤2.5 times the normal value upper limit | |
e) Alanine aminotransferase ≤2.5 times the normal value upper limit | |
f) Total bilirubin ≤1.5 times the normal value upper limit | |
g) Creatinine ≤1.5 times the normal value upper limit or creatinine clearance < 50 mL/min (Cockcroft–Gault formula) | |
h) SpO2 ≥ 90% (with or without oxygen therapy) | |
9 | Written informed consent |
Exclusion criteria | |
1 | EGFR exon 20 insertions |
2 | Synchronous or metachronous active double malignancies |
3 | History of interstitial lung disease, drug-induced pneumonitis, radiation pneumonitis requiring systemic steroid therapy, or active interstitial pneumonitis |
4 | Ingestion not possible or refractory nausea and vomiting |
5 | Presence of active infections requiring antibiotics |
6 | Severe psychological disorder |
7 | Active brain metastasis |
8 | Serious uncontrolled medical conditions |
9 | Systemic administration of steroids for 4 weeks or longer (prednisolone-equivalent doses within 20 mg/day are allowed) |
10 | ECOG PS reduction due to comorbidities |
11 | Major surgery or radiation therapy with more than 30% of bone marrow or widespread radiation within 4 weeks prior to enrollment |
12 | QT prolongation on resting electrocardiogram (QTc ≥ 470 ms) |
13 | History of hypersensitivity to osimertinib |
14 | Pregnant, currently breastfeeding, positive pregnancy test results, or unwilling to practice contraception during this study |
15 | Other conditions not suitable for this study |