Non-small cell lung cancer
Conditions
Interventions
Sponsors
Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)patients with pathologically proven non-small cell lung cancer 2)patients with stage IIIB or IV who are not candidates for curative radiotherapy 3)patients with prior chemotherapy regimens three or less 4)patients having EGFR mutation (exon 18, exon 19 or Exon 21) 5)no prior treatment with EGFR tyrosine kinase inhibitor 6)possible cases with oral administration 7)performance status (ECOG)0-2 8)patient who has measurable lesions by RECIST 9)close and meticulous clinical observation with (or without) hospitalization during the first four weeks of treatment 10)patients aged 20 years or older 11)sufficient function of main organ and bone marrow 12)more than 4 weeks after the last chemotherapy 13)signed informed consent
Exclusion criteria
Exclusion criteria: 1)previous radiotherapy to primary lung cancer 2)superior vena caval syndrome 3)severe drug allergy 4)large peritoneal or pericardial effusion 5)active infection 6)continuous watery diarrhea 7)intestinal paralysis or ileus 8)interstitial pneumonia or lung fibrosis evident on CT 9)symptomatic ophthalmologic disease 10)current or previous (within the last 1 year) history of GI perforation 11)serious non-healing ulcer 12)Symptomatic or steroid-requiring brain metastases 13),14)active concomitant malignancy 15)uncontrolled diabetes 16)severe cardiac disease 17)severe psychological disease 18)pregnant or lactating women or those who declined contraception 19)those judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, response rate in patients who have stable disease after dose escalation , progression free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactHideo Kunitoh
Japanese Red Cross Medical Center Division of Chemotherapy Department of Internal Medicine
Outcome results
None listed