Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)
NCT ID: NCT02118415
Last Updated: 2024-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2014-03-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional
Interventional group: activated autologous NK cells as a drug
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)
Control group
Control group: BSC
No interventions assigned to this group
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Locations
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Klinikum rechts der Isar, Strahlentherapie und Radiologische Onkologie
Munich, , Germany
Countries
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Other Identifiers
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2008-002130-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NSCLC-TKD/IL-2
Identifier Type: -
Identifier Source: org_study_id
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