Clinical trial NCT02118415: Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)
Official title: Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSCLC Stage IIIA/B
Keywords: not eligible for surgery
efficacy of immunotherapy following RCTx
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Progress free survival
timeFrame: follow up after randomization for at least 18 months
Secondary outcomes:
measure: overall survival (OS)
timeFrame: follow up after randomization for at least 18 months
measure: toxicity (AE and SAE)
timeFrame: follow up after randomization for at least 18 months
measure: quality of life (QoLQ-30, LC-13)
timeFrame: follow up after randomization for at least 18 months
measure: biological parameters (NK cell activation)
timeFrame: follow up after randomization for at least 18 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Strahlentherapie und Radiologische Onkologie
Study officials:
References: