A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302)
Phase 2
- Conditions
- Chemo-naive patients with squamous cell lung cancer
- Registration Number
- JPRN-UMIN000011897
- Lead Sponsor
- OSAKA-LCSG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1.Adjuvant chemotherapy of PTX 2.Active synchronous malignancy 3.Symptomatic brain metastasis 4.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 5.>= G2 peripheral neuropathy 6.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. 7.serious complication ischemic heart disease, cardiac arrhythmia, post-MI, hepatic cirrhosis, gastrointestinal ulcer, DM 8.History of severe drug allergy 9.Women with a possibility of pregnancy, pregnant or lactating 10.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS), PFS in cases given maintenance therapy, Overall survival (OS), Maintenance extraction rates, Frequency and grade of adverse event