Non-small Cell Lung CancerNCT02515760
Tumor-specific T Cells in Lung Cancer
A study testing Bone marrow aspiration from the iliac crest and Illinois bone marrow aspiration neddle in people with Non-small Cell Lung Cancer, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Bone marrow aspiration from the iliac crest and Illinois bone marrow aspiration neddle
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Autoimmune disease
- Patients receiving immunomodulatory drugs, e.g. tacrolimus
- Prior malignancy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Thoracic Surgery, Technical University of Munich, Munich, Germany
Munich, 81675
About this study
Official title: Tumor-specific Effector T Cells in Non-small Cell Lung Cancer
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Bone marrow aspiration from the iliac crest, Illinois bone marrow aspiration neddle
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow aspiration from the iliac crestProcedure or surgery
Illinois bone marrow aspiration neddleDevice
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer group | Experimental | Bone marrow puncture in patients with non-small cell lung cancer Receives: Procedure: Bone marrow aspiration from the iliac crest; Device: Illinois bone marrow aspiration neddle |
| Control group (healthy donors) | Experimental | Bone marrow puncture in healthy donors Receives: Procedure: Bone marrow aspiration from the iliac crest; Device: Illinois bone marrow aspiration neddle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of tumor-specific T cells
% of all T cells
Measured: 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
location: peripheral versus bone marrow
Measured: 2 weeks postoperative
Long-term survival
OS
Measured: 5 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startFeb 2014
- Primary completionJun 2018
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center, Heidelberg University
- Responsible party
- Principal investigator, Dr. med. Seyer Safi, University Hospital Heidelberg
- Investigators
- Seyer Safi, MD, PhD, Principal investigator, Division Thoracic Surgery, Technical University of Munich, Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515760
- Sponsor's protocol ID
- S-515/2013
- Status last verified
- Dec 2024
- First submitted
- 30 Jul 2015
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29617574Safi 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.
PubMed 33255425Safi 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.
PubMed 31741774Safi 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.
PubMed 29147626
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor-specific Effector T Cells in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02515760
- Acronym / sponsor ID
- S-515/2013
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- German Cancer Research Center, Heidelberg University
- Study start
- Feb 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung cancer group | Experimental | Procedure: Bone marrow aspiration from the iliac crest, Device: Illinois bone marrow aspiration neddleBone marrow puncture in patients with non-small cell lung cancer |
| Control group (healthy donors) | Experimental | Procedure: Bone marrow aspiration from the iliac crest, Device: Illinois bone marrow aspiration neddleBone marrow puncture in healthy donors |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Autoimmune disease
- Patients receiving immunomodulatory drugs, e.g. tacrolimus
- Prior malignancy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow aspiration from the iliac crest | Procedure or surgery | Control group (healthy donors), Lung cancer group |
| Illinois bone marrow aspiration neddle | Device | Control group (healthy donors), Lung cancer group |
Primary outcome
Frequencies of tumor-specific T cells
Time frame: 2 weeks postoperative
% of all T cells
2 secondary outcomes
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
Time frame: 2 weeks postoperative
Long-term survival
Time frame: 5 years postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 29617574Yamauchi 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.
- Results publication: PubMed 33255425Safi 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.
- Results publication: PubMed 31741774Safi 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.
- Results publication: PubMed 29147626Safi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyer Safi, MD, PhD principal investigator
Division Thoracic Surgery, Technical University of Munich, Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone marrow aspiration from the iliac crest and Illinois bone marrow aspiration neddle in people with Non-small Cell Lung Cancer, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of tumor-specific T cells (time frame: 2 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515760, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.