Randomized Phase II clinical trial of personalized peptide vaccination for patients with advanced (stage IIIB/IV) or recurrence non-small cell lung cancer who had chemotheraphy of 1 or 2 regimen, to evaluate the progression free survial of docetaxel plus placebo versus docetaxel plus pesonalized pepitide vaccine.
Phase 2
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000003521
- Lead Sponsor
- Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Not provided
Exclusion Criteria
The following patients must be excluded. 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. 3) Patients who are during pregnancy, lactation expectant, and desiring future fertility. 4) Patients who are judged inappropriate for the clinical trial by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of antitumor activity (progression free survival) of peptide vaccination.
- Secondary Outcome Measures
Name Time Method 1.Evaluation of response rate and long-term prognosis (overall survival). 2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTCAE (v 4.0). 3.Evaluation of immunological responses (anti-peptide IgG) before