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Adjuvant treatment of novel multiple cancer vaccine restricted with HLA-A24 for patients with completely resected non-small cell lung cancer. randomized phase II trial

Adjuvant treatment of novel multiple cancer vaccine restricted with HLA-A24 for patients with completely resected non-small cell lung cancer. randomized phase II trial - Adjuvant treatment of multiple cancer vaccine for patients with completely resected non-small cell lung cancer. randomized phase II trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009380
Enrollment
60
Registered
2012-12-01
Start date
2009-01-01
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

multiple vaccine with Montanide ISA51 VG matched with HLA-A24 1. URLC10 (up regulated lung cancer 10,LY6K) 2. CDCA1 (cell division cycle associated 1) 3. VEGFR1 4. VEGFR2 multiple vaccine with Mo

Sponsors

Fukushima Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Pathologically confirmed stage IB-IV NSCLC 2)Completely resected NSCLC by lobectomy or more with lymph node dissection 3)Age of 20 years or older 4)ECOG performance status 0-1 5)With adequate major organ functions as defined below: *White blood cell count 1,500-15000/mm3 *Platelet count >= 75,000/mm3 *AST <= 3 times institutional normal range *ALT <= 3 times institutional normal range *Creatinine <= 2 times institutional normal range 6) Be able to start within 4 week after surgery in patients without adjuvant chemotherapy treatment and within 6 week after adjuvant chemotherapy 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1. With uncontrollable ischemic heart disease and/or arhythmia 2. With acute myocardial infarction 6 months before treatment 3. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 4. With double cancer, multiple cancer 5. With active inflammatory disease 6. With steroidal or immunosuppressive agent dependency 7. Physician concludes that the patient's participation in this trial is inappropriate

Design outcomes

Primary

MeasureTime frame
Recurrence free survival

Secondary

MeasureTime frame
Overall survival Antigen specific T cell responses

Countries

Japan

Contacts

Public ContactSUZUKI Hiroyuki

Fukushima Medical University Chest Surgery

hiro@fmu.ac.jp024-547-1111

Outcome results

None listed

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