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

Study Overview
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Brief Summary
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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)

Detailed Description
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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).

Official Title
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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)

Conditions
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NSCLC Stage IIIA/B

Intervention / Treatment
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* Other: Hsp70-peptide TKD/IL-2 activated, autologous NK cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Interventional group: activated autologous NK cell treatment | Other: Hsp70-peptide TKD/IL-2 activated, autologous NK cells<br>* Adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine)<br>|
| No Intervention: Control group<br>Control group: BSC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival |  | follow up after randomization for at least 18 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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not eligible for surgery, efficacy of immunotherapy following RCTx