Non-Small Cell Lung Cancer, Non-Squamous cell lung cancer
Conditions
Interventions
If four or more of the 6-12 patients who had been originally allocated to the level 0 experienced DLT, additional 6-12 patients were enrolled to the level -1. If four or more patients experienced DLT
Sponsors
National Hospital Organization Kyushu Medical Center,Department of Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histology/cytology-proven non-squamous non-small cell lung cancer 2)Stage IIIB, IV and unsuitable for radiotherapy and postoperative recurrence 3)EGFR mutant patients(exclude T790M mutation) 4)With one or more measurable disease based on RECIST 5)Performance status(ECOG): 0-1 6)Age 20<80 7)Adequate organ function 8)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Interstitial pneumonia/lung fibrosis on chest X-ray 2) History of chest radiation therapy 3) History or complication of hemoptysis with 2.5ml per time or more and Continuous bloody phlegm more than 1 week or complication of bloody phlegm treated with continuous oral hemostatic agent. History or complication of bloody phlegm treated with infusional hemostatic agent. 4) Evidence of tumor invading a perihilar blood vessel, heart and major blood vessel on imaging 5) Evidence of tumor invading segmental bronchus 6) Symptomatic brain metastasis 7) Active hepatic disease 8) Having serious complications 9) Uncontrolled ascites, pleural effusion or cardiac effusion 10) History of multiple malignancies within 3 years 11) Planning of surgery during the trial 12) A pregnant woman, a nursing girl and woman with the possibility (intention) of the pregnancy, and 13) Having serious mental disorder 14) Previous drug allergy 15) Those judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of Pemetrexed/Bevacizumab/Erlotinib | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-tumor efficacy | — |
Countries
Japan
Contacts
Public ContactMasao Ichiki
National Hospital Organization Kyushu Medical Center Department of Respiratory Medicine
Outcome results
None listed