non-small-cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. pathologically proven non-squamous non-small cell lung cancer 2. harboring active EGFR mutation other than exon 20 T790M 3. stage IV or ineligibility as candidates for curative treatment 4. measurable tumor sites 5. no prior chemotherapy no prior systemic anticancer therapy 6. ECOG PS of 0 to 1 7. appropriate organ function 8. expected to live for more than 3 months 9. acquisition of written informed consent
Exclusion criteria
Exclusion criteria: 1. symptomatic brain metastasis 2. pts with hemoptysis with 2.5mL or more 3. pts with radiological findings of tumor invasion to major vessels (i.e. aorta) and cavity lesion 4. pts with bleeding tendency pts who need continuous use of antithrombotic agents 5. candidate for curative radiation therapy 6. have a history of severe drug allergy 7. woman who is pregnant or wishing to become pregnant 8. pts with massive pleural and cardiac effusion and ascites that need to be immediately treated 9. pts with active co-morbidities including severe conditions of heart diseases, infections, uncontrollable diabetes, uncontollable hypertension, interstitial pneumonia, active hepatitis and thrombotic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | — |
Countries
Japan