Non-small Cell Lung CancerRadImmuneNCT02319408
Immune Boost In Non-Small Cell Lung Cancer
A study testing Preoperative radiation in people with Non-small Cell Lung Cancer, run by University Hospital Heidelberg at 2 sites in Germany.
Trial summary
Insufficient migration and activation of tumour specific effector T cells seems to be the one important reason for inadequate host anti-tumour immune response. Ionizing radiation can induce a variety of immune responses. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Preoperative radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2016to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven clinical stage I to IIA pulmonary adenocarcinoma
- Lung tumor is felt to be curatively resectable by the treating physicians
- Sufficient pulmonary function for lobectomy according to current guidelines
- The patient is free of distant metastases as confirmed by contrast-enhanced chest and upper abdomen CT-scan and by contrast-enhanced CT or MRI of the brain
- Age over 50years at the time of consent due to federal radiation protection law
- In female patients of childbearing potential there must be a negative pregnancy test
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- Eastern Cooperative Oncology Group performance status of 0,1, 2 or 3 at the time of randomization
- Patients who the investigator believes can and will comply with the requirements of this protocol
- Written informed consent according to good clinical practise and national/regional regulations
Who cannot join
- The patient shows clinical signs of pneumonia
- The patient receives immunosuppressive drugs (alkylating agents, antimetabolites, methotrexate, azathioprine, mercaptopurine, cytotoxic antibodies, ciclosporin, tacrolimus, sirolimus, interferon, mycophenolate, small biological agents)
- The patient has been diagnosed with a potential immune mediated disease
- Elevated blood leukocyte count or erythrocyte sedimentation rate
- Pregnancy
- The patient has received any cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy or chemotherapy
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- The patient is diagnosed with a concomitant malignancy and/or has a history of malignancy within the past five years or has had a malignancy that has been in complete remission for less than 5 years
- The patient needs chronic long term oxygen therapy
- The patient has undergone splenectomy
- The patient is known to be HIV positive
- The patient has an uncontrolled bleeding disorder
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Thoracic Surgery, Thoraxklinik, University Hospital Heidelberg
Heidelberg, 69126
German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg
Heidelberg, 69126
About this study
Official title: A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer
Insufficient migration and activation of tumour specific effector T cells seems to be the one important reason for inadequate host anti-tumour immune response. Ionizing radiation can induce a variety of immune responses. The goal of this randomized trial is to assess if a preoperative single fraction low dose radiation is able to improve anti-tumour immune response in operable early stage lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Preoperative radiation
- 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.
Preoperative radiationRadiation
Lobectomy for lung cancer following preoperative radiation
| Study group | Role | What they receive |
|---|---|---|
| No radiation | No intervention | Lobectomy for lung cancer without preoperative radiation |
| Preoperative radiation | Experimental | Lobectomy for lung cancer with preoperative radiation Receives: Radiation: Preoperative radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cluster of differentiation (CD)8+ T cells in resected NSCLC
Frequencies of CD8+ T cells in resected NSCLC tumors determined by immunohistochemistry
Measured: 7 days
Secondary outcomes (1)
T cell subtypes in resected NSCLC
Frequencies of CD3+, CD4+, CD45RO and Foxp3+ T cells in resected NSCLC tumors determined by immunohistochemistry and flow cytometry
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startApr 2016
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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, University Hospital HeidelbergHans Hoffmann, MD, PhD, Principal investigator, University Hospital HeidelbergPeter Huber, MD, PhD, Principal investigator, German Cancer Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319408
- Sponsor's protocol ID
- S-576/ 2013
- Acronym
- RadImmune
- Status last verified
- May 2022
- First submitted
- 27 May 2014
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Klug F, Prakash H, Huber PE, Seibel T, Bender N, Halama N, Pfirschke C, Voss RH, Timke C, Umansky L, Klapproth K, Schakel K, Garbi N, Jager D, Weitz J, Schmitz-Winnenthal H, Hammerling GJ, Beckhove P. Low-dose irradiation programs macrophage differentiation to an iNOS(+)/M1 phenotype that orchestrates effective T cell immunotherapy. Cancer Cell. 2013 Nov 11;24(5):589-602. doi: 10.1016/j.ccr.2013.09.014. Epub 2013 Oct 24.
PubMed 24209604Safi S, Beckhove P, Warth A, Benner A, Roeder F, Rieken S, Debus J, Dienemann H, Hoffmann H, Huber PE. A randomized phase II study of radiation induced immune boost in operable non-small cell lung cancer (RadImmune trial). BMC Cancer. 2015 Dec 19;15:988. doi: 10.1186/s12885-015-2006-2.
PubMed 26686362
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02319408
- Acronym / sponsor ID
- RadImmune / S-576/ 2013
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- German Cancer Research Center, Heidelberg University
- Study start
- Apr 2016
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 18 Dec 2014 (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.
Insufficient migration and activation of tumour specific effector T cells seems to be the one important reason for inadequate host anti-tumour immune response. Ionizing radiation can induce a variety of immune responses. The goal of this randomized trial is to assess if a preoperative single fraction low dose radiation is able to improve anti-tumour immune response in operable early stage lung cancer.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No radiation | No intervention | –Lobectomy for lung cancer without preoperative radiation |
| Preoperative radiation | Experimental | Radiation: Preoperative radiationLobectomy for lung cancer with preoperative radiation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven clinical stage I to IIA pulmonary adenocarcinoma
- Lung tumor is felt to be curatively resectable by the treating physicians
- Sufficient pulmonary function for lobectomy according to current guidelines
- The patient is free of distant metastases as confirmed by contrast-enhanced chest and upper abdomen CT-scan and by contrast-enhanced CT or MRI of the brain
- Age over 50years at the time of consent due to federal radiation protection law
Key exclusion criteria (11 listed)
- The patient shows clinical signs of pneumonia
- The patient receives immunosuppressive drugs (alkylating agents, antimetabolites, methotrexate, azathioprine, mercaptopurine, cytotoxic antibodies, ciclosporin, tacrolimus, sirolimus, interferon, mycophenolate, small biological agents)
- The patient has been diagnosed with a potential immune mediated disease
- Elevated blood leukocyte count or erythrocyte sedimentation rate
- 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 |
|---|---|---|
| Preoperative radiationLobectomy for lung cancer following preoperative radiation | Radiation | Preoperative radiation |
Primary outcome
Cluster of differentiation (CD)8+ T cells in resected NSCLC
Time frame: 7 days
Frequencies of CD8+ T cells in resected NSCLC tumors determined by immunohistochemistry
1 secondary outcome
T cell subtypes in resected NSCLC
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Background: PubMed 24209604Klug F, Prakash H, Huber PE, Seibel T, Bender N, Halama N, Pfirschke C, Voss RH, Timke C, Umansky L, Klapproth K, Schakel K, Garbi N, Jager D, Weitz J, Schmitz-Winnenthal H, Hammerling GJ, Beckhove P. Low-dose irradiation programs macrophage differentiation to an iNOS(+)/M1 phenotype that orchestrates effective T cell immunotherapy. Cancer Cell. 2013 Nov 11;24(5):589-602. doi: 10.1016/j.ccr.2013.09.014. Epub 2013 Oct 24.
- Results publication: PubMed 26686362Safi S, Beckhove P, Warth A, Benner A, Roeder F, Rieken S, Debus J, Dienemann H, Hoffmann H, Huber PE. A randomized phase II study of radiation induced immune boost in operable non-small cell lung cancer (RadImmune trial). BMC Cancer. 2015 Dec 19;15:988. doi: 10.1186/s12885-015-2006-2.
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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
University Hospital Heidelberg
Hans Hoffmann, MD, PhD principal investigator
University Hospital Heidelberg
Peter Huber, MD, PhD principal investigator
German Cancer Research Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative radiation in people with Non-small Cell Lung Cancer, run by University Hospital Heidelberg at 2 sites 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cluster of differentiation (CD)8+ T cells in resected NSCLC (time frame: 7 days). 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 NCT02319408, which also lists 2 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 23 May 2022.