Non-small cell lung cancer
Conditions
Interventions
Afatinib 40mg orally once daily
Sponsors
Shinshu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically diagnosed non-squamous non-small cell lung cancer harboring drug sensitive EGFR mutation (exon19 deletion, L858R) 2) ECOG PS 0 or 1 3) Confirming disease progression after first line osimertinib monotherapy 4) Received at least one regimen of anticancer chemotherapy (cytotoxic agents, immune checkpoint inhibitor, anti-angiogenic inhibitors) as a second-line therapy after osimertinib resistance 5) Undergoing next generation sequencing-based gene panel tests after osimertinib resistance 6) Having at least one target legion for RECIST ver.1.1 7) Adequate organ functions judged by laboratory tests within 14 days prior to registration AST<=100 U/L ALT<=100 U/L creatinine<=2.0 mg/dL SpO2>=92%
Exclusion criteria
Exclusion criteria: 1) Having active multiple malignancies 2) Having active infectious disease (hepatitis B, hepatitis C, tuberculosis, HIV infection) 3) Pregnancy, breastfeeding or suspected of being pregnant 4) Undergoing concurrent anticancer therapy (chemotherapy, radiotherapy, immunotherapy, biological therapy, hormonal therapy) 5) Undergoing surgical treatment with organ removal within 28 days prior to registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety (incidence rate and severity of adverse events) Progression-free survival (PFS) Overall survival (OS) | — |
Countries
Japan
Contacts
Public ContactTaisuke Araki
Shinshu University School of Medicine First Department of Internal Medicine
Outcome results
None listed