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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02118415
Recruitment Status : Suspended
First Posted : April 21, 2014
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

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

Condition or disease Intervention/treatment Phase
NSCLC Stage IIIA/B Other: Hsp70-peptide TKD/IL-2 activated, autologous NK cells Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : March 2014
Actual Primary Completion Date : March 28, 2018
Estimated Study Completion Date : March 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Interventional
Interventional group: activated autologous NK cell treatment
 Other: Hsp70-peptide TKD/IL-2 activated, autologous NK cells
Adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine)
No Intervention: Control group
Control group: BSC


Outcome Measures
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Primary Outcome Measures :
  1. Progress free survival [ Time Frame: follow up after randomization for at least 18 months ]

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: follow up after randomization for at least 18 months ]
  2. toxicity (AE and SAE) [ Time Frame: follow up after randomization for at least 18 months ]
  3. quality of life (QoLQ-30, LC-13) [ Time Frame: follow up after randomization for at least 18 months ]
  4. biological parameters (NK cell activation) [ Time Frame: follow up after randomization for at least 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118415


Locations
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Germany
Klinikum rechts der Isar, Strahlentherapie und Radiologische Onkologie
Munich, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Hanno Specht, Dr. Klinikum rechts der Isar, TU München
More Information
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02118415    
Other Study ID Numbers: NSCLC-TKD/IL-2
2008-002130-30 ( EudraCT Number )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Keywords provided by Technische Universität München:
not eligible for surgery
efficacy of immunotherapy following RCTx
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases