Patients with non-squamous non-small cell lung cancer previously untreated
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1)Histological or cytological diagnosis of non-squamous NSCLC (2)Provided written consent in person for participation in this study (3)Age 20 years or older (4)ECOG Performance Status (PS) 0 to 2 (5)Life expectancy of more than three months (6)Have measurable lesions according to the Response Evaluation Criteria in Solid Tumors ver1.1 (7)Have adequate function of major organs (bone marrow, liver, kidneys) defined as follows: Neutrophils>=1,500 /mm3 Platelets>=100,000 /mm3 Hemoglobin>8.0 g/dl AST and ALT<=100IU/l Serum creatinine<=1.5 mg/dl (8)one prior chemotherapy excluded adjuvant chemotherapy, EGFR-TKI and ALK inhibitor (9)no administration of Paclitaxel previously
Exclusion criteria
Exclusion criteria: (1)Received transfusion or G-CSF within 14 days prior to enrollment (2)Urine protein>=2+ (3)History of drug allergy (4)Active multiple cancers (5)Severe infection (6)High fever (7)Abnormal cardiac function (8)Severe pulmonary disease; Interstitial pneumonia, severe COPD, pulmonary thromboembolism (9)History of hematoemesis, ileus and gastroduodenal ulcer (10)Need for drainage of pleural effusion, acsites or pericardial effusion (11)Medically uncontrolled thromboembolism (12)Symptomatic CNS metastases previously untreated (13)CNS or Psychological disorders (14)Medically uncontrolled hypertension or diabetes mellitus (15)Nonhealing wound and surgery within 4 weeks before treatment (16)History of hemoptysis; one-half teaspoon of bright red blood per event (17)Recent use of aspirin (>=325 mg/day) (18)Severe bone marrow suppression (19)Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Disease control rate, Overall response rate, Time to treatment failure, Overall survival | — |
Countries
Japan
Contacts
Faculty of Medicine, Tottori University Division of Medical Oncology and Molecular Respirology