Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00010746

Trial Description

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Title

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

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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).

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Organizational Data

  •   DRKS00010746
  •   2016/06/29
  •   2014/02/25
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2008-002130-30 
  •   NCT02118415  (ClinicalTrials.gov)
  •   NSCLC-TKD/IL-2  (Technische Universität München)
  •   2008-002130-30 
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Health Condition or Problem studied

  •   NSCLC Stage IIIA/B
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Other: Hsp70-peptide TKD/IL-2 activated, autologous NK cells
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Progress free survival; time frame: follow up after randomization for at least 18 months

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Secondary Outcome

- overall survival (OS); time frame: follow up after randomization for at least 18 months
- toxicity (AE and SAE); time frame: follow up after randomization for at least 18 months
- quality of life (QoLQ-30, LC-13); time frame: follow up after randomization for at least 18 months
- biological parameters (NK cell activation); time frame: follow up after randomization for at least 18 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2014/03/31
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional 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

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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

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Addresses

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    • Technische Universität München
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    • Klinikum rechts der Isar, TU München
    • Michael Molls, Prof. 
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    •   [---]*
    •   [---]*
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    • Hanno Specht, Dr. 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2016/06/22
* This entry means the parameter is not applicable or has not been set.