Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)
2 other identifiers
interventional
13
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2014
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedApril 17, 2024
November 1, 2023
4.1 years
February 25, 2014
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progress free survival
follow up after randomization for at least 18 months
Secondary Outcomes (4)
overall survival (OS)
follow up after randomization for at least 18 months
toxicity (AE and SAE)
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
Study Arms (2)
Interventional
EXPERIMENTALInterventional group: activated autologous NK cells as a drug
Control group
NO INTERVENTIONControl group: BSC
Interventions
Adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum rechts der Isar, Strahlentherapie und Radiologische Onkologie
Munich, 81675, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2014
First Posted
April 21, 2014
Study Start
March 1, 2014
Primary Completion
March 28, 2018
Study Completion
March 1, 2019
Last Updated
April 17, 2024
Record last verified: 2023-11