Non-squamous non-small-cell lung cancer
Conditions
Interventions
Nab-paclitaxel(100mg/m2) on day1,8,15 plus carboplatin (AUC 6) and bevacizumab(15 mg/kg) on day1 given every 4 weeks for 4 cycles(max 6cycles). For patients with response or stable disease, bevacizuma
Sponsors
Kyorin University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Eligibility criteria for induction 1) Histologically or cytologically comfirmed non-squamous, non-small cell lung cancer 2) Stage IIIB/IV or postoperative recurrence Non-Sq NSCLC 3) Chemo-naive patients (contain EGFR-TKI and ALK-TKI) * Recurrence more than 6 months ago after completion of postoperable adjuvant chemotherapy is acceptable. * OK432 pleurodesis for malignant pleural effusion is acceptable. 4) Palliative radiotherapy (thorax excluded) 5) At least one measureable lesion per RECIST 1.0 6) Patients aged 20 or older, 75 under 7) ECOG performance status of 0 or 1 8) Adequate organ function within 2 weeks * Leukocyte count > or = 3,000/mm3 * Neutrophil count > or = 1,500/mm3 * Platelet count > or = 100,000/mm3 * Hemoglobin concentration > or = 9.0 g/dl * AST and ALT levels < or = 100IU/L * Total bilirubin level < or = 1.5mg/dl * Serum creatinine levels < or = 1.2mg/dl * SpO2 > or = 92% (room air) * Urinary protein < or = 1+ * Acceptable cardiac function * Peripheral neuropathy < or = grade 1 9)Estimating Survival more than 3 months 10)Written informed consent (2)Eligibility Criteria for maintenance therapy 1)Recover within 43 days after start of last cycle of induction therapy. 2)More than 3 cycles of induction chemotherapy and response criteria of induction chemotherapy achieved more than and equal to SD. 3)ECOG performance status of 0 or 1 4) Adequate organ function within 2 weeks * Neutrophil count > or = 1500/mm3 * Hemoglobin concentration > or = 8.0 g/dl * Platelet count > or = 100000/mm3 * AST and ALT levels < or = 100IU/L * Total bilirubin level < or = 1.5mg/dl * Serum creatinine levels < or = 1.5mg/dl * SpO2 > or = 92% (room air) * Peripheral neuropathy < or = grade 2 * Hypertension < or = grade 2 * proteinuria < or = grade 2 * any bleeding < or = grade 1 * thromboembolic event absence
Exclusion criteria
Exclusion criteria: 1)SVC synd 2)Active concomitant malignancy except carcinoma in situ, intra-mucosal carcinoma or cancer with more than 5 year disease free 3)Severe active infection and sever complication (gastrointestinal hemorrhage,cardiac disease) 4)Pregnant status or lactation 5)Uncontrolled psychiatric disease 6)History of allergic reaction for agents of present treatment 7)Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage 8)A history of significant hemoptysis (> 2.5 mL red blood per episode) before enrolment 9)Evidence of tumor invading large vessel on imaging, cavity and thrombus 10)History of thromboembolic events.Any history of cerebral, myocardial, and pulmonary infarction 11)Symptomatic brain metastasis 12)History of operation and biopsy within 4 weeks 13)Need to antiplatelet therapy or anticoagulation therapy without Aspirin 324 mg/day within 10 days 14)Bleeding tendency, blood coagulation disorder 15)Bowel obstruction 16)Current or previous history of gastrointestinal perforation and diverticulitis 17)Pulmonary fibrosis and interstitial pneumonia on chest X-ray or symptomatic pulmonary fibrosis and interstitial pneumonia 18)Uncontrolled hypertension and diabetes 19)Other ineligible status judged by medical oncologist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival,progression free survival, safety,QOL | — |
Countries
Japan
Contacts
Public ContactTakuma Yokoyama
Kyorin University School of Medicine Department of Respiratory Medicine
Outcome results
None listed