Phase I study of Wilms' tumor gene WT1 peptide vaccination combined with gemcitabine for patients with advanced non-small-cell lung cancer

Phase I study of Wilms' tumor gene WT1 peptide vaccination combined with gemcitabine for patients with advanced non-small-cell lung cancer - Phase I study of Wilms' tumor gene WT1 peptide vaccination combined with gemcitabine for patients with advanced non-small-cell lung cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005226

Enrollment

Registered

2011-03-10

Start date

2011-04-01

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

advanced or recurrent non-small-cell lung cancer

Interventions

Gemcitabine 1,000 mg/m2/day day1,8,15 WT1 peptide days1,15 q4w , 2 cycle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histological diagnosis of lung cancer 2)informed of lung cancer 3)failure of standard treatments 4)WT1 expressing cancer 5)HLA type HLA-A-2402 6)PS 0-1 7)age over 20 under 80 8)four weeks or more must pass from the prior treatment 9)Patients expected of 3 months or more survival 10)brain metastases controlled if present 11)lesion that can be evaluated by RECIST 12) Adequate organ function AST and ALT <=4 times the standard values Total bilirubin <2.0mg/dL Creatinine <2.0mg/dL ECG normal SpO2>92% 13)Written consent

Exclusion criteria

Exclusion criteria: 1)other active disease 2)pregnancy 3)previous administration of GEM 4)active bleeding or hematological disorders 5)HBV,HCV,HIV carriers 6)active infection 7)progressive brain, meningeal or bone metastasis 8)autoimmnune disorders 9)drug allergies 10)During treatment with immunosuppressive agents 11)interstitial pneumonia 12)Severe psychiatric disease 13)Patients whom doctors judged inadequate to the enrollment of this study by other reasons

Design outcomes

Primary

Measure	Time frame
safety	—

Secondary

Measure	Time frame
Response rate Progression free survival Overall survival Immune induction	—

Countries

Japan

Contacts

Public ContactYotaro Izumi

School of Medicine, Keio University Division of General Thoracic Surgery

03-3353-1211ext62333

Outcome results

None listed

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

Phase I study of Wilms&#39; tumor gene WT1 peptide vaccination combined with gemcitabine for patients with advanced non-small-cell lung cancer