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

April 15, 2024 updated by: Technical University of Munich
Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81675
        • Klinikum rechts der Isar, Strahlentherapie und Radiologische Onkologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
Interventional group: activated autologous NK cells as a drug
Other: Hsp70-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)
No Intervention: Control group
Control group: BSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progress free survival
Time Frame: follow up after randomization for at least 18 months
follow up after randomization for at least 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival (OS)
Time Frame: follow up after randomization for at least 18 months
follow up after randomization for at least 18 months
toxicity (AE and SAE)
Time Frame: follow up after randomization for at least 18 months
follow up after randomization for at least 18 months
quality of life (QoLQ-30, LC-13)
Time Frame: follow up after randomization for at least 18 months
follow up after randomization for at least 18 months
biological parameters (NK cell activation)
Time Frame: follow up after randomization for at least 18 months
follow up after randomization for at least 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Hanno Specht, Dr., Klinikum rechts der Isar, TU München

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

March 28, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimated)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSCLC-TKD/IL-2
  • 2008-002130-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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