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 Munich

Status and phase

Completed

Phase 2

Conditions

NSCLC Stage IIIA/B

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02118415

NSCLC-TKD/IL-2

2008-002130-30 (EudraCT Number)

Details and patient eligibility

About

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

Full 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).

Enrollment

13 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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