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).

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