Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)
Conditions
NSCLC Stage IIIA/B
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
not eligible for surgery, efficacy of immunotherapy following RCTx
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Hsp70-peptide TKD/IL-2 activated, autologous NK cells
Type: Other
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Klinikum rechts der Isar, Strahlentherapie und Radiologische Onkologie
Munich, Germany
Status: Recruiting
Contact: Hanno Specht, Dr. - +49 (0)89 4140 - Hanno.Specht@lrz.tu-muenchen.de
Start Date
March 2014
Completion Date
February 2018
Sponsors
Technische Universität München
Source
Technische Universität München
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page