Non-small-cell lung cancer
Conditions
Interventions
Sponsors
Shizuoka cancer center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmation of non-small-cell lung cancer 2) Stage IIIB/IV and chemo-naive non-small-cell lung cancer 3) ECOG PS 2 4) Evaluable lesions 5) Aged 20 or more 6) Adequate organ functions 7) Expected survival over 90 days 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Symptomatic brain metastasis 2) Interstitial pneumonia with usual interstitial pneumonia pattern on chest CT 3) Grade 2 or more peripheral sense neuropathy 4) With uncontrolled pleural effusion, ascites or pericardial effusion 5) Treated with palliative radiotherapy within the past two weeks 6) Active concomitant malignancy 7) Severe complication 8) HBs antigen positive 9) Previous severe drug allergy 10) Continuous systemic administration of steroid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Dose limiting toxicity Phase II: Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: Adverse event, Response rate Phase II: Adverse event, Response rate, Overall survival | — |
Countries
Japan
Contacts
Public ContactKazuhisa Nakashima
Shizuoka cancer center Division of Thoracic Oncology
Outcome results
None listed