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Study of S-588410 After Adjuvant Chemotherapy for Completely Resected Non-small- Cell Lung Cancer

Phase 2
Conditions
Non-small- Cell Lung Cancer
Interventions
Drug: Placebo
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
Inclusion Criteria
  1. Patients who received platinum-based adjuvant chemotherapy after the complete resection of lung cancer.
  2. Pathologically determined non-small-cell lung cancer excepting the large cell neuroendocrine carcinoma and mixed type.
  3. Patients with HLA-A*24:02.
  4. Neither recurrence nor metastasis of non-small-cell lung cancer demonstrated by imaging tests within 6 weeks prior to the registration.
  5. Possible to receive S-588410 within 12 weeks after the last adjuvant chemotherapy.
  6. ECOG performance status 0 or 1 within 2 weeks prior to the registration.
  7. Age over 20 years at time of consent acquisition.
  8. The written informed consent provided by the patient.
Exclusion Criteria
  1. Other malignant diseases requiring treatment, excepting the cured cancer in-situ.
  2. Concurrent treatment with anticancer drug, steroids, immunosuppressive agent, radiotherapy, immunotherapy, hyperthermia, or surgery.
  3. Active and uncontrolled infectious disease.
  4. Severe hepatic dysfunction, kidney dysfunction, cardiac disease, pulmonary disease, hematological disorder, or metabolic disease.
  5. Coronary artery stenting within 6 months prior to registration.
  6. Autoimmune disease.
  7. HIV infection.
  8. Registration within 4 weeks after the last adjuvant chemotherapy.
  9. Laboratory values defined in the protocol within 2 weeks prior to registration.
  10. Residual uncontrolled adverse events by adjuvant chemotherapy.
  11. Eosinophilia within 28 days prior to registration. Past or active eosinophilic pneumonia or interstitial pneumonitis.
  12. Past history of severe allergic reaction against drug, vaccine and biological agents.
  13. Female patient in nursing or pregnancy.
  14. Refusal of pregnancy conception.
  15. Treated with the same peptide vaccines as S-588410.
  16. Treated with another investigational drug within 28 days prior to registration or the period of 5 times of the drug half-life.
  17. 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
GroupInterventionDescription
S-588410S-588410Subjects with HLA-A\*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
PlaceboPlaceboSubjects with HLA-A\*2402 in the placebo arm will receive the subcutaneous administration of placebo.
Primary Outcome Measures
NameTimeMethod
Relapse-free Survival Time as a Measure of Efficacy2 years
Secondary Outcome Measures
NameTimeMethod
Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability4 years
Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides2 years
Overall Survival Time as a Measure of Efficacy4 years
Relapse-free Survival Rate after Randomization as a Measure of Efficacy1 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 Biomarker4 years
Overall Survival Rate after Randomization as a Measure of Efficacy1 and 2 years

Trial Locations

Locations (1)

Institute of Medical Science, The University of Tokyo

🇯🇵

Tokyo, Japan

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