EGFR mutated non-small cell lung cancer patients with postoperative recurrence
Conditions
Interventions
Patients treated with afatinib 40mg per day until disease progression and/or intolerable toxic effect.
Sponsors
Gunma university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Eligible patients had pathologically confirmed NSCLC and non-squamous carcinoma according to American Joint Committee on Cancer criteria. 2)Postoperative recurrent patient and no adaptation of surgery or radiotherapy for recurrent site. 3)Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST) 4)Tumour tissue had to be EGFR mutation-positive at the screening,including common (Leu858Arg, exon 19 deletions) 5)Chemotherapy native patients 6)An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7)Patient have adequate organ function
Exclusion criteria
Exclusion criteria: Patients were excluded 1)if they had interstitial pneumonia, pneumoconiosis, Radiation pneumonitis, drug-induced pneumonia. 2)Patient had already received EGFR-TKI 3)Patient had uncontrollable pleural effusion, ascites, pericardial effusion 4)Patient had uncontrolled concomitant diseases, baseline organ function. 5)Patients suspected of being pregnant or lactating women 6)Patients had brain tumors and/or brain metastases (symptomatic or requiring treatment) 7)Patients had additional significant malignancies diagnosed within the past 5 years 8)Tumour tissue had to T790M EGFR mutation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Over all survival Response rate Safety | — |
Countries
Japan
Contacts
Public ContactKai Obayashi
Gunma University Graduate School of Medicine General surgical science
Outcome results
None listed