EGFR-mutated non-small-cell lung cancer
Conditions
Interventions
Afatinib 40mg is administered by internal use once a day. When a prescriptive adverse event appeared, reduce the affatinib dose in 30mg from 40mg.Still when admitting a presscriptive adverse event, re
Sponsors
North Japan Lung Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed non-small cell lung cancer 2. clinical stage IIIB or IV or postoperative recurrence 3. admitted EGFR gene mutation except for T790M or exon20 insertion 4. No prior EGFR-TKI therapy 5. Prior therapy of platinum-combined chemotherapy within one regimen is permitted (postoperative adjuvant chemotherapy is not included) 6. Prior therapy of immuno-checkpoint inhibitor within one regimen is permitted 7. with measurable lesion 8. ECOG PS 0-2 9. lifeexpectancy of at least 3 months 10. with ritten informed consent 11. with adequate organ function
Exclusion criteria
Exclusion criteria: 1. previously treated by EGFR-TKI 2. admitted EGFR gene mutation of T790M or exon20 insertion 3. symptomatic brain metastasis 4. with interstitial pneumonia or pulmonary fibrosis 5. with active other malignancies 6. with massive effusion required tube drainage 7. with active infection 8. with severe comorbidities 9. with other conditions that is considered inappropriate for the study by an attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progressive free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progresson free survival response rate incidence of adverse event incidence of adverse event of grade 3 or more | — |
Countries
Japan
Contacts
Public ContactAkira Inoue
North Japan Lung Cancer Study Group office
Outcome results
None listed