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

NSCLC Stage IIIA/B Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT02118415
• Other study ID #: NSCLC-TKD/IL-2
• Secondary ID: 2008-002130-30
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: March 2019

Study information

• Verified date: November 2023
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2019
• Est. primary completion date: March 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC Stage IIIA/B

Intervention

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)

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar, Strahlentherapie und Radiologische Onkologie	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress free survival		follow up after randomization for at least 18 months
Secondary	overall survival (OS)		follow up after randomization for at least 18 months
Secondary	toxicity (AE and SAE)		follow up after randomization for at least 18 months
Secondary	quality of life (QoLQ-30, LC-13)		follow up after randomization for at least 18 months
Secondary	biological parameters (NK cell activation)		follow up after randomization for at least 18 months