CBDCA+nab-PTX vs DOC for elderly Sq NSCLC Phase III study
- Conditions
- Elderly patients with advanced squamous non-small-cell lung cancer
- Registration Number
- JPRN-jRCTs041180110
- Lead Sponsor
- Gemma Akihiko
- Brief Summary
The combination of carboplatin plus nab-paclitaxel in advanced squamous cell lung cancer in elderly patients significantly prolongs overall survival and is a more useful treatment than docetaxel.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 196
1) Histologically or cytologically confirmed advanced squamous non-small-cell lung cancer
2) Clinical stage IIIB (not amenable to curative radiation), IV or recurrent disease
3) Regardless of the presence of measurable lesions
4) 70 years of age or older
5) Performance status of 0 or 1
6) Adequate organ function
7) life expectancy 12 weeks or more at day1
8) Written informed consent
1) symptomatic central nervous system metastases
2) A past hypersensitive for polysorbate or albumin
3) peripheral neuropathy CTCAE Grade 2 or more
4) uncontrolled pericardial or pleural effusion or ascites
5) prior palliative radiotherapy for metastatic lesion within 14 days before registration
6) Synchronous or metachronous active double malignancies
7) Infectious disease requiring systemic treatment or severe complications
8) do not consent to contraception
9) Positive for HBs antigen
10) positive for HBs antibody or HBc antibody, and positive for HBV-DNA
11) patients who have been judged by the investigator to be inappropriate in this clinical trial for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Progression-free survival, response rate, toxicity, quality of life