Non-small cell lung cancer
Conditions
Interventions
Afatinib is prescribed at 20mg/day daily. If tolerated, this dose can be increased after 21 days of treatment.
Sponsors
Kyoto Thoracic Oncology Research Group (KTORG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histological or cytological proven NSCLC 2)With sensitive EGFR mutation: Exon 19 deletion or Exon 21 L858R mutation 3)No indication for operation or radiation therapy 4)Chemotherapy-naive advanced or relapsed NSCLC 5)If after adjuvant or neoadjuvant chemotherapy: No molecular target drug 4 weeks after treatment without platinum agent 6)interval of radiation therapy: 1 weeks after thoracic RT 7)age: over 20 8)ECOG PS: 0-2 9)Adequate organ functions judged by laboratory tests 10)Life expectanancy: over 3 months 11)Written informed consent
Exclusion criteria
Exclusion criteria: 1)obvious interstitial pneumonia or pulmonary fibrosis by chest CT 2)uncontrolled pleural or pericardial effusion 3)symptomatic brain metastasis 4)active multiple tumor 5)cannot take orally 6)obvious liver cirrhosis 7)clinically significant heart disease 8)infection which requires treatment 9)pregnancy 10)history of severe allergic reaction 11)anticontraceptive 12)inadequate patients whom physicians considered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Safety Response rate | — |
Countries
Japan
Contacts
Public ContactToshihide Yokoyama
Kurashiki Central Hospital Department of Respiratory Medicine
Outcome results
None listed