NCT02410369UnknownPhase 2
Phase II Study of S-588410 as Maintenance Monotherapy After Adjuvant Chemotherapy in Patients With Completely Resected Non-small- Cell Lung Cancer
Tokyo University1 site in 1 country60 target enrollmentStarted: March 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Relapse-free Survival Time as a Measure of Efficacy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •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.
Exclusion Criteria
- •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-
- •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.
Arms & Interventions
S-588410
Active Comparator
Subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
Intervention: S-588410 (Drug)
Placebo
Placebo Comparator
Subjects with HLA-A*2402 in the placebo arm will receive the subcutaneous administration of placebo.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Relapse-free Survival Time as a Measure of Efficacy
Time Frame: 2 years
Secondary Outcomes
- 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)
Investigators
Yataro Daigo
Project Professor
Tokyo University
Study Sites (1)
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