Phase I/II clinical study of WT4869 peptide-based immunotherapy in patients with completely resected stage IA with vascular invasion, stage IB and stage II non-small cell lung cancer with WT1 antigen positive.
- Conditions
- Completely resected NSCLC, stage IA with vascular invasion and stage IB/II with WT1 antigen positive.
- Registration Number
- JPRN-UMIN000010027
- Lead Sponsor
- Osaka University Graduate School of Medicine, Department of Functional Diagnosis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 237
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method