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Table 1 Key eligibility criteria

From: Rationale and protocol design of a phase II study of first-line osimertinib treatment for patients with poor performance status and EGFR mutation-positive non-small cell lung cancer (OPEN/TORG2040)

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

  1. NSCLC non-small cell lung cancer, EGFR epidermal growth factor receptor, ECOG Eastern Cooperative Oncology Group, PS performance status, RECIST Response Evaluation Criteria in Solid Tumors, QTc corrected QT