Non-small cell lung cancer
Conditions
Interventions
Afatinib
Sponsors
Gunma University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically and/or cytologically proven NSCLC 2. Unresectable clinical stage IIIB/IV 3. Measurable or evaluable disease for RECIST 1.1 4. Patients who have sensitive EGFR mutation (exon19 deletion, exon21 L858R) 5. Patients who have never treated with EGFR-TKI TKI
Exclusion criteria
Exclusion criteria: 1) Patient with serious disease condition (severe heart disease, interstitial pneumonia, uncontrollable hypertension, diabetes mellitus, etc) 2) Age < 70 years old 3) Patients who have previously treated with EGFR-TKI 4) Patient with much ascetic fluid, pleural effusion, cardiac effusion. 5) Patient with active infection 6) Considered as unfit to study drug administration by attending doctor according to clinical symptomatic olthalmic disorder 7) Pregnancy 8) Symptomatic brain metastases 9) Patient with active double cancer (Exclude disease free interval over 5 years and carcinoma in situ) 10) Patients who have exon 20 T790M 11) Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities. 12) Current smoker 13) Considered to be interfere to the agreement or understanding the protocol by attening doctor. Other ineligible status judged by attending doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Overall Response Rate Safety | — |
Countries
Japan
Contacts
Public ContactKyouichi Kaira
Gunma University Graduate School of Medicine Oncology Clinical Development
Outcome results
None listed