Description:
Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients
with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)
Title
- Brief Title: 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)
Clinical Trial IDs
- ORG STUDY ID:
NSCLC-TKD/IL-2
- SECONDARY ID:
2008-002130-30
- NCT ID:
NCT02118415
Conditions
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Interventional | Experimental | Interventional group: activated autologous NK cell treatment | |
Control group | No Intervention | 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
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progress free survival |
Time Frame: | follow up after randomization for at least 18 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | overall survival (OS) |
Time Frame: | follow up after randomization for at least 18 months |
Safety Issue: | |
Description: | |
Measure: | toxicity (AE and SAE) |
Time Frame: | follow up after randomization for at least 18 months |
Safety Issue: | |
Description: | |
Measure: | quality of life (QoLQ-30, LC-13) |
Time Frame: | follow up after randomization for at least 18 months |
Safety Issue: | |
Description: | |
Measure: | biological parameters (NK cell activation) |
Time Frame: | follow up after randomization for at least 18 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Suspended |
Lead Sponsor: | Technische Universität München |
Trial Keywords
- not eligible for surgery
- efficacy of immunotherapy following RCTx
Last Updated
January 15, 2019