NCT02515760

Brief Summary

Non-small cell lung cancer is characterized by aggressive growth and treatment resistance. New approaches include immunotherapeutic strategies but spontaneous immune responses against tumor antigens remain unclear. The aim of this study is to characterize localization and frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

February 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

4.3 years

First QC Date

July 30, 2015

Last Update Submit

December 8, 2024

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Frequencies of tumor-specific T cells

    % of all T cells

    2 weeks postoperative

Secondary Outcomes (2)

  • Tumor-specific T cells location determined by Enzyme Linked Immuno Spot Assay (ELISPOT) analysis of peripheral blood and bone marrow samples from the same patient

    2 weeks postoperative

  • Long-term survival

    5 years postoperative

Study Arms (2)

Lung cancer group

EXPERIMENTAL

Bone marrow puncture in patients with non-small cell lung cancer

Procedure: Bone marrow aspiration from the iliac crestDevice: Illinois bone marrow aspiration neddle

Control group (healthy donors)

EXPERIMENTAL

Bone marrow puncture in healthy donors

Procedure: Bone marrow aspiration from the iliac crestDevice: Illinois bone marrow aspiration neddle

Interventions

Bone marrow aspiration from the iliac crestPROCEDURE
Control group (healthy donors)Lung cancer group
Illinois bone marrow aspiration neddleDEVICE
Control group (healthy donors)Lung cancer group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histology proven non-small cell lung cancer or a lesion suspicious of non-small cell lung cancer (lung cancer group)
  • Healthy donors (control group)
  • written informed consent

You may not qualify if:

  • Autoimmune disease
  • Patients receiving immunomodulatory drugs, e.g. tacrolimus
  • Prior malignancy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Thoracic Surgery, Technical University of Munich, Munich, Germany

Munich, 81675, Germany

Location

Related Publications (4)

  • Yamauchi Y, Safi S, Blattner C, Rathinasamy A, Umansky L, Juenger S, Warth A, Eichhorn M, Muley T, Herth FJF, Dienemann H, Platten M, Beckhove P, Utikal J, Hoffmann H, Umansky V. Circulating and Tumor Myeloid-derived Suppressor Cells in Resectable Non-Small Cell Lung Cancer. Am J Respir Crit Care Med. 2018 Sep 15;198(6):777-787. doi: 10.1164/rccm.201708-1707OC.

    PMID: 29617574BACKGROUND

  • Safi S, Yamauchi Y, Hoffmann H, Weichert W, Jost PJ, Winter H, Muley T, Beckhove P. Circulating Interleukin-4 Is Associated with a Systemic T Cell Response against Tumor-Associated Antigens in Treatment-Naive Patients with Resectable Non-Small-Cell Lung Cancer. Cancers (Basel). 2020 Nov 24;12(12):3496. doi: 10.3390/cancers12123496.

    PMID: 33255425RESULT

  • Safi S, Yamauchi Y, Stamova S, Rathinasamy A, Op den Winkel J, Junger S, Bucur M, Umansky L, Warth A, Herpel E, Eichhorn M, Winter H, Hoffmann H, Beckhove P. Bone marrow expands the repertoire of functional T cells targeting tumor-associated antigens in patients with resectable non-small-cell lung cancer. Oncoimmunology. 2019 Oct 23;8(12):e1671762. doi: 10.1080/2162402X.2019.1671762. eCollection 2019.

    PMID: 31741774RESULT

  • Safi S, Yamauchi Y, Rathinasamy A, Stamova S, Eichhorn M, Warth A, Rauch G, Dienemann H, Hoffmann H, Beckhove P. Functional T cells targeting tumor-associated antigens are predictive for recurrence-free survival of patients with radically operated non-small cell lung cancer. Oncoimmunology. 2017 Sep 8;6(11):e1360458. doi: 10.1080/2162402X.2017.1360458. eCollection 2017.

    PMID: 29147626RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Seyer Safi, MD, PhD

    Division Thoracic Surgery, Technical University of Munich, Munich, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. Seyer Safi

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 5, 2015

Study Start

February 1, 2014

Primary Completion

June 1, 2018

Study Completion

September 1, 2025

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)