EGFR-mutant non-small cell lung carcinoma with recurrent/advanced stage
Conditions
Interventions
Group A: Afatinib 40mg/day
Group B: Osimertinib 80mg/day
Group A: T790M positive by re-biopsy, the next treatment drug must be osimertinib 80mg/day
Sponsors
Seki Nobuhiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-small, non-squamous cell lung carcinoma. 2) Stage IIIB, IIIC or IV non-squamous, non-small cell lung cancer including post operation recurrence. 3) Harboring sensitizing EGFR mutations with histological or cytological specimen except for de novo T790M. 4) Measurable disease, as defined by RECIST ver 1.1. 5) No prior cytotoxic chemotherapy or immunotherapy and appropriate for administration of 1st line afatinib or osimertinib. 6) 20 years or older. 7) ECOG PS 0 or 1. 8) Adequate hematologic and end organ function. 9) Predicted at least 3 months prognosis. 10) Permitted re-biopsy before 2nd line treatment by any procedure. 11) Written informed consent form.
Exclusion criteria
Exclusion criteria: 1) History of interstitial lung disease or radiation pneumonitis. 2) Malignancies other than NSCLC within 2 years. 3) Adjuvant chemotherapy within a year. 4) Uncontrolled infectious disease. 5) Women who are pregnant, lactating, or intending to become pregnant during the study 6) Uncontrolled heart, lung, liver, renal diseases. 7) Other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate at 3 years Exploratory analysis of immunological biomarker | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival 1 Progression-free survival 2 Overall survival Time to discontinuation of treatment or death1 Time to discontinuation of treatment or death2 Time to first subsequent therapy or death Objective response rate | — |
Contacts
Public ContactShigeru Tanzawa
Teikyo University Hospital
Outcome results
None listed