Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)

Phase 2

Completed

• Conditions: NSCLC Stage IIIA/B
• Interventions: Other: Hsp70-peptide TKD/IL-2 activated, autologous NK cells

• Registration Number: NCT02118415
• Lead Sponsor: Technical University of Munich

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).

Study Timeline

• Study First Submitted: 2014-02-25
• Study Start: 2014-03
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Primary Completion: 2018-03-28
• Study Completion: 2019-03
• Status Verified: 2023-11
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	Hsp70-peptide TKD/IL-2 activated, autologous NK cells	Interventional group: activated autologous NK cells as a drug

Primary Outcome Measures

Name	Time	Method
Progress free survival	follow up after randomization for at least 18 months

Secondary Outcome Measures

Name	Time	Method
toxicity (AE and SAE)	follow up after randomization for at least 18 months
overall survival (OS)	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

Trial Locations

Locations (1)

Klinikum rechts der Isar, Strahlentherapie und Radiologische Onkologie; 🇩🇪 Munich, Germany