Study of S-588410 After Adjuvant Chemotherapy for Completely Resected Non-small- Cell Lung Cancer
- Registration Number
- NCT02410369
- Lead Sponsor
- Tokyo University
- Brief Summary
In this clinical study, the investigators evaluate the efficacy and safety of S-588410 in patients who underwent an adjuvant chemotherapy after the complete resection of non-small-cell lung cancer.
- Detailed Description
In this phase II trial, the investigators evaluate the efficacy and safety of S-588410 containing oncoantigens-derived HLA-A\*2402-restricted epitope peptides in patients with HLA-A\*2402 who underwent an adjuvant chemotherapy after the complete resection of non-small-cell lung cancer.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Patients who received platinum-based adjuvant chemotherapy after the complete resection of lung cancer.
- Pathologically determined non-small-cell lung cancer excepting the large cell neuroendocrine carcinoma and mixed type.
- Patients with HLA-A*24:02.
- Neither recurrence nor metastasis of non-small-cell lung cancer demonstrated by imaging tests within 6 weeks prior to the registration.
- Possible to receive S-588410 within 12 weeks after the last adjuvant chemotherapy.
- ECOG performance status 0 or 1 within 2 weeks prior to the registration.
- Age over 20 years at time of consent acquisition.
- The written informed consent provided by the patient.
- Other malignant diseases requiring treatment, excepting the cured cancer in-situ.
- Concurrent treatment with anticancer drug, steroids, immunosuppressive agent, radiotherapy, immunotherapy, hyperthermia, or surgery.
- Active and uncontrolled infectious disease.
- Severe hepatic dysfunction, kidney dysfunction, cardiac disease, pulmonary disease, hematological disorder, or metabolic disease.
- Coronary artery stenting within 6 months prior to registration.
- Autoimmune disease.
- HIV infection.
- Registration within 4 weeks after the last adjuvant chemotherapy.
- Laboratory values defined in the protocol within 2 weeks prior to registration.
- Residual uncontrolled adverse events by adjuvant chemotherapy.
- Eosinophilia within 28 days prior to registration. Past or active eosinophilic pneumonia or interstitial pneumonitis.
- Past history of severe allergic reaction against drug, vaccine and biological agents.
- Female patient in nursing or pregnancy.
- Refusal of pregnancy conception.
- Treated with the same peptide vaccines as S-588410.
- Treated with another investigational drug within 28 days prior to registration or the period of 5 times of the drug half-life.
- Decision of non-enrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S-588410 S-588410 Subjects with HLA-A\*2402 in the investigational arm will receive the subcutaneous administration of S-588410. Placebo Placebo Subjects with HLA-A\*2402 in the placebo arm will receive the subcutaneous administration of placebo.
- Primary Outcome Measures
Name Time Method Relapse-free Survival Time as a Measure of Efficacy 2 years
- Secondary Outcome Measures
Name Time Method Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability 4 years Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides 2 years Overall Survival Time as a Measure of Efficacy 4 years Relapse-free Survival Rate after Randomization as a Measure of Efficacy 1 and 2 years Association between Overall Survival Time as a Measure of Efficacy and Gene Variation detected by Genomics Methods in Lymphocytes as a Predictive Biomarker 4 years Overall Survival Rate after Randomization as a Measure of Efficacy 1 and 2 years
Trial Locations
- Locations (1)
Institute of Medical Science, The University of Tokyo
🇯🇵Tokyo, Japan