Completely resected NSCLC, stage IA with vascular invasion and stage IB/II with WT1 antigen positive.
Conditions
Interventions
<
Phase I portion>
WT4869 3 mg will be administered 5 times every week, followed by 4 times every 2 weeks, and 10 times every 4 weeks.
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WT4869 6 mg will be administered 5 times every week, followed by 4 times every 2 weeks, and 10 times every 4 weeks.
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Phase II portion>
Recommended dose of WT4869 will be administered 5 times every week, followed by 4 times every 2 weeks, and 10 times every 4 weeks.
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Placebo will be administered 5 times every week, followed by 4 times every 2 weeks, and 10 times every 4 weeks.
Sponsors
Osaka University Graduate School of Medicine, Department of Functional Diagnosis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients confirmed non-small cell lung cancer with pathologically. 2. The pathological stage is IA with vascular invasion, IB or II.(UICC ver.7) Patients who are intolerant to standard therapy or refuse standard therapy. 3. Tumor cells are judged WT1 antigen positive by immunohistochemistry. 4. Patients with HLA-A*24:02 positive. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status is 0 or 1. 6. The level of surgical resection is higher than lobectomy. 7. ND2a or higher level lymph node dissection or selective lymph node dissection has been conducted. 8. Patients who is pathologically confirmed complete resection. 9. Trial treatment can be started within 56 days after resection. 10.No other treatments except surgery have been carried out for lung cancer. 11.Patients should be 20 years or older at informed consent. 12.Functions of major organs are maintained, satisfying the following conditions. 1) Neutrophil count >= 1,500/uL 2) Platelet count >= 75,000 /uL 3) Hemoglobin concentration >= 10.0 g/dL 4) Serum creatinine <= 1.5xULN 5) Total bilirubin <= 2.0 mg/dL 6) AST/ALT <= 3.0xULN 7) SpO2 >= 95% 13.Agree to prevent pregnancy from the time of obtaining the first consent to 6 months after the final administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Patients with residual tumor after surgery. 2. Patients with active double cancer. 3. Patients requiring systemic-immunosuppressive agents or moderate or higher dose of steroid within 28 days before enrollment. 4. Patients had a blood transfusion or administered hematopoietic factor formulation within 14 days before enrollment. 5. Patients administered the other study drug or investigational product within 28 days before enrollment. 6. Patients with history of WT1 peptide administration. 7. Patients with HIV antibody, HBs antigen, HCV antibody positive. 8. Patients with MDS, MDS/MPD, MPD. 9. Patients with pulmonary fibrosis or interstitial pneumonitis. 10.Patients with severe complication. 11.Patients with history of allergy for oil formulation and severe drug hypersensitivity. 12.Pregnant or lactating women or women for childbearing potential, and men who want to get partner pregnant. 13.Patients with psychosis. 14.Inadequate physical condition, as diagnosed by the primary physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Phase I portion> Ratio of dose-limiting toxicity Estimate of the maximum tolerated dose Ratio of adverse events <Phase II portion> Ratio of 2-years relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| <Phase I portion> Relapse-free survival (RFS) Overall survival (OS) Ratio of the patients who completed study treatment Type of recurrence WT1-antigen specific immune responses Non-immunological monitoring <Phase II portion> Overall survival (OS) Ratio of the patients who completed study treatment Type of recurrence WT1-antigen specific immune responses Non-immunological monitoring Ratio of adverse events | — |
Countries
Japan
Contacts
Public ContactHiroshi Miyamoto
Secretariat of clinical trial coordinating committee (none)
Outcome results
None listed