Clinical Trials /

Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)

NCT02118415

Description:

Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)

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

Suspended

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)
  • Official Title: Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)

Clinical Trial IDs

  • ORG STUDY ID: NSCLC-TKD/IL-2
  • SECONDARY ID: 2008-002130-30
  • NCT ID: NCT02118415

Conditions

  • NSCLC Stage IIIA/B

Purpose

Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)

Detailed Description

      Patients with non-small cell lung carcinoma (NSCLC) in stage III A and III B showing at least
      stable disease after RCTx will be enrolled into the clinical trial. The aim of the study is
      to show the efficacy of an adjuvant treatment with Hsp70-peptide TKD/IL-2 activated,
      autologous NK cells following completion of standard radiochemotherapy
      (Cisplatin/Vinorelbine). Patients will be randomized 1:1 either to the interventional study
      group to receive 4 cycles of autologous immunotherapy with activated NK cells or to the
      control group (BSC).
    

Trial Arms

NameTypeDescriptionInterventions
InterventionalExperimentalInterventional group: activated autologous NK cell treatment
    Control groupNo InterventionControl group: BSC

      Eligibility Criteria

              Inclusion Criteria:
      
                -  First diagnosis of histologically and/or cytologically proven and unresectable NSCLC
                   with clinically stage III A and III B
      
                -  Completion of radiochemotherapy no longer than 8 weeks ago
      
                -  Progression free according to RECIST criteria at the first assessment after completion
                   of RCTx
      
                -  Confirmed presence of Hsp70 on patient´s tumors
      
                -  ECOG Status(Appendices) ≤ 2
      
              Exclusion Criteria:
      
                -  Any severe heart disease or any severe concomitant disease (ECOG stage > 2)
      
                -  NSCLC patients (stage IIIA/B) eligible for initial surgery with a confirmed consent of
                   an interdisciplinary tumorboard
      
                -  Patients that show ALK positivity or an activating mutation of the EGFR-TK domain
      
                -  Patients with locally advanced or metastatic non-small cell lung cancer other than
                   predominantly squamous cell histology
      
                -  Receipt of immunosuppressive drugs including high dose systemic corticosteroids within
                   3 weeks before study entry. Low dose corticosteroids as they are a common treatment
                   option for patients suffering from COPD are not an exclusion criterium
            
      Maximum Eligible Age:75 Years
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Progress free survival
      Time Frame:follow up after randomization for at least 18 months
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:overall survival (OS)
      Time Frame:follow up after randomization for at least 18 months
      Safety Issue:
      Description:
      Measure:toxicity (AE and SAE)
      Time Frame:follow up after randomization for at least 18 months
      Safety Issue:
      Description:
      Measure:quality of life (QoLQ-30, LC-13)
      Time Frame:follow up after randomization for at least 18 months
      Safety Issue:
      Description:
      Measure:biological parameters (NK cell activation)
      Time Frame:follow up after randomization for at least 18 months
      Safety Issue:
      Description:

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Technische Universität München

      Trial Keywords

      • not eligible for surgery
      • efficacy of immunotherapy following RCTx

      Last Updated

      September 19, 2016