Non-small cell lung cancer
Conditions
Interventions
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) Previous treated with platinum combination chemotherapy 6) Patients who have never treated with EGFR-TKI 7) PS (ECOG): 0-2 8) Age: over 20, under 75 9) Adequate organ functions judged by laboratory tests 10) Interval of operation: 4 weeks after operation 11) Life expectancy: over 3 months 12) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patient with serious disease condition (severe heart disease, interstitial pneumonia, uncontrollable hypertension, diabetes mellitus, etc) 2) Age 20-74 years old 3) Patients who have previously treated with EGFR-TKI 4) Platinum combination chemotherapy naive 5) Patient with much ascetic fluid, pleural effusion, cardiac effusion. 6) Patient with active infection 7) Considered as unfit to study drug administration by attending doctor according to clinical symptomatic olthalmic disorder 8) Pregnancy 9) Symptomatic brain metastases 10) Patient with active double cancer (Exclude disease free interval over 5 years and carcinoma in situ) 11) Patients who have exon 20 T790M 12) Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities. 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 |
|---|---|
| Response rate Overall survival Safety | — |
Countries
Japan
Contacts
Public ContactKyoichi Kaira
Gunma University Graduate School of Medicine Oncology Clinical Development
Outcome results
None listed