Non-squamous Non-small Cell Lung Cancer
Conditions
Interventions
Bevacizumab (15mg/kg, day 1) with cisplatin (75mg/m2, day 1) plus pemetrexed (500mg/m2, day 1) is administered every three weeks until four cycles. After the completion of four cycles, bevacizumab (15
Sponsors
Hanshin Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)Stage IIIB, stage IV or recurrent disease after surgery 3)Asymptomatic brain metastases less than 2 cm diameter without urgent local therapy. Extra brain lesion: With measurable or inmeasurable lesion 4)If the patient underwent radiotherapy, there should be the following interval between the radiotherapy and the registration i)Radiotherapy including pulmonary field: not permissible ii)Radiotherapy other than thoracic radiation ->1 week 5)Over 20 years old 6)ECOG PS 0-1 7)Adequate organ function 8)Life expectancy more than 3 months 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2)History of severe drug allergy 3)History of active infection or other serious disease condition (GI bleeding,etc.) 4)History of poorly controlled pleural effusion,pericardial effusion and ascites 5)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc.) 6)Uncontrollable hypertension 7)Uncontrollable diabetes mellitus 8)Hystory of active double cancer 9)Invasion to main blood vessels 10)History of active psychological disease 11)Severe hemoptysis or blood sputum 12)History of gastrointestinal perforation 13)Symptomatic or more than 2 cm diameter brain metastases 14)Uncured bone fracture (excluding compression fracture due to osteoporosis) 15)Planned surgery 16)Obvious cavity on pulmonary lesions. 17)Bleeding tendency 18)Uncontrolled thromboembolizm 19)Pregnancy 20)Participation in the trial is judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival 2. Response rate 3. Disease control rate 4. Progression free survival, response rate, and disease control rate of brain metastases 5. Safety | — |
Countries
Japan
Contacts
Public ContactAkito Hata
Institute of Biomedical Research and Innovation Division of Integrated Oncology
Outcome results
None listed