previously untreated advanced non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Cytologically or histologically documented non-small cell carcinoma of the lung. 2)previously untreated recurrence with distant metastasis after surgery, or previously untreated clinical stage IV or IIIB (including only patients with no indications for curative radiotherapy) 3) age older thean 20years at the time of registration 4) Have Eastern Cooperative Oncology Group performance status (PS) of 0 or 1 5) Have measurable lesions (RECIST version1.1) 6) Have adequate organ function within 14 days before study entry leucocytes >3000/mm3 neutrophils>1,500/mm3 platelets >100,000/mm3 hemoglobin > 9g/dl], adequate hepatic function adequate renal function partial pressure of arterial oxygen>60Torr or Peripheral capillary oxygen saturation>90% 8) Have signed an informed consent document
Exclusion criteria
Exclusion criteria: 1)History of radiotherapy for a primary lesion 2)Superior vena cava syndrome 3)Hisstory of severe drug allergy 4)With massive or uncontrolled pleural effusion 5)With massive or uncontrolled pericardial effusionor ascites 6)With active infection 7)interstitial pneumoia/active lung fibrosis on chest x-ray 8)With symptomatic brain metastasis 9)active concomitant malignancy 10)Uncontrolled psychiatric disease 11)Peripheral sensory or motor neuropathy severe than Grade 2(by CTCAE ver4.0) 12)Others judged by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| determine the recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Efficacy | — |
Countries
Japan
Contacts
Hyogo Prefectural Amagasaki Hospital Department of Respiratory Medicine