NSCLC Stage IIIA/B
Conditions
Keywords
not eligible for surgery, efficacy of immunotherapy following RCTx
Brief 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).
Interventions
OTHERHsp70-peptide TKD/IL-2 activated, autologous NK cells
Adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine)
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants of the intervention group receive biological product (ex vivo activated, autologous NK cells), participants of the control group receive no biological product
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival | follow up after randomization for at least 18 months |
Secondary
| Measure | Time frame |
|---|---|
| toxicity (AE and SAE) | follow up after randomization for at least 18 months |
| quality of life (QoLQ-30, LC-13) | follow up after randomization for at least 18 months |
| biological parameters (NK cell activation) | follow up after randomization for at least 18 months |
| overall survival (OS) | follow up after randomization for at least 18 months |
Countries
Germany
Outcome results
None listed