Clinical Trials /

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

NCT02410369

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of S-588410 After Adjuvant Chemotherapy for Completely Resected Non-small- Cell Lung Cancer
  • Official Title: Phase II Study of S-588410 as Maintenance Monotherapy After Adjuvant Chemotherapy in Patients With Completely Resected Non-small- Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: IMS2643
  • SECONDARY ID: UMIN000016979
  • NCT ID: NCT02410369

Conditions

  • Non-small- Cell Lung Cancer

Interventions

DrugSynonymsArms
S-588410S-588410
PlaceboPlacebo

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
S-588410Active ComparatorSubjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
  • S-588410
PlaceboPlacebo ComparatorSubjects with HLA-A*2402 in the placebo arm will receive the subcutaneous administration of placebo.
  • Placebo

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Relapse-free Survival Time as a Measure of Efficacy
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Relapse-free Survival Rate after Randomization as a Measure of Efficacy
Time Frame:1 and 2 years
Safety Issue:
Description:
Measure:Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides
Time Frame:2 years
Safety Issue:
Description:
Measure:Overall Survival Time as a Measure of Efficacy
Time Frame:4 years
Safety Issue:
Description:
Measure:Overall Survival Rate after Randomization as a Measure of Efficacy
Time Frame:1 and 2 years
Safety Issue:
Description:
Measure:Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability
Time Frame:4 years
Safety Issue:
Description:
Measure:Association between Overall Survival Time as a Measure of Efficacy and Gene Variation detected by Genomics Methods in Lymphocytes as a Predictive Biomarker
Time Frame:4 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Tokyo University

Last Updated

December 20, 2017