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

Technical University of Munich13 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NSCLC Stage IIIA/B

Interventions

Hsp70-peptide TKD/IL-2 activated, autologous NK cellsOTHER

Adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinikum rechts der Isar, Strahlentherapie und Radiologische Onkologie

Munich, Germany