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.

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. - Randomized Phase II study of peptide vaccination in non-small cell lung cance patients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003521

Enrollment

Registered

2010-04-22

Start date

2010-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Arm 1: personalized peptide vaccine plus docetaxel (1st treatment: total 8 times, every 1 weeks) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must be satisfactory the following conditions. 1) patients had chemotheraphy of 1 or 2 regimen. 2) patients must be at a score level 0-1 of ECOG performance status. 3) patients must have IgGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types. 4) Patients in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33). 5) Patients must satisfy the followings. WBC is less than 12000 per mm3 Lymphocyte is more than 1000 per mm3 Hb is more than 8.0 g per dL Platelet is more than 100,000 per mm3 Serum creatinine is less than 1.5 mg/dl Total bilirubin is less than 1.5 mg/dl 6) patients must be more than 20 years old. 7) Patients must be expected to survive more than 3 months. 8) Written informed consent must be obtained from patients. 9) Prior treatment are allowed and mustcomplete 4 weeks before random assignment with full recovery of related toxicity.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Evaluation of antitumor activity (progression free survival) of peptide vaccination.	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division

akiymd@med.kurume-u.ac.jp0942-31-7572

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026