A phase II study of WT1-W10 peptide vaccine monotherapy for patients with previously-treated advanced Non-Small Cell Lung Cancer

A phase II study of WT1-W10 peptide vaccine monotherapy for patients with previously-treated advanced Non-Small Cell Lung Cancer - A phase II study of WT1 vaccine for previously-treated NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013742

Enrollment

Registered

2014-05-01

Start date

2014-05-01

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

immunotherapy of WT1-W10 peptide vaccine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). 2) Patients whose cancer cells express WT1, or patients with undetermined WT1 status due to tissue unavailability. 3) Patients who have previously been treated with at least one chemotherapy regimen. Postoperative oral UFT therapy does not mean previous chemotherapy regimen. 4) Patients who have one of the following HLA types: A*24:02, A*02:01, A*02:06, A*02:07. 5) Performance status (ECOG) 0-2. 6) Patients who has at least one or more measurable lesion(s) by RECIST. 7) Sufficient function of main organ and bone marrow filling the following criteria: Neutrophil counts, 1,500/mm3 or over. Platelets, 100,000/mm3 or over. AST and ALT, x 2.5 of upper limit of normal (ULN) or less. Total bilirubin, 1.5 mg/dl or less. Serum creatinin, x 1.5 of ULN or less. SpO2 90% or above (while breathing ambient air). 8) Patients who are considered to survive for more than 6 months. 9) Patients providing written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with active concomitant malignancy. 2) Patients with active and severe infection, requiring intravenous antibiotics and/or anti fungal agents. 3) Patients with active lung disease such as idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, or drug-induced pneumonitis, and considered as inappropriate for the study by the physicians. 4) Patients with uncontrollable complications (e.g. uncontrollable heart disease, uncontrollable effusion and/or pericardial effusion, symptomatic brain metastasis, severe arrhythmia, and so on). 5) Pregnancy or lactation. 6) Patients with mental disorder, and considered as inappropriate for the study by the physicians. 7) Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
response rate (RR)	—

Secondary

Measure	Time frame
disease control rate (DCR), progression free survival (PFS), overall survival (OS), evaluation of safety and specific immune response	—

Countries

Japan

Contacts

Public ContactTetsuya Kubota

Kochi University, School of Medicine Department of Hematology and Respiratory Medicine

im25@kochi-u.ac.jp088-880-2345

Outcome results

None listed

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