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

NCT02118415•Technical University of Munich

Summary

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

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

March 1, 2014

Primary Completion Date

March 28, 2018

Completion Date

March 1, 2019

Last Updated

April 17, 2024

Enrollment

ACTUAL participants

Conditions

NSCLC Stage IIIA/B

Interventions

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

OTHER