Clinical trial NCT02319408: Immune Boost In Non-Small Cell Lung Cancer
Official title: A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
name: Heidelberg University
First posted: 2014-12-18
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Cluster of differentiation (CD)8+ T cells in resected NSCLC
timeFrame: 7 days
Secondary outcomes:
measure: T cell subtypes in resected NSCLC
timeFrame: 7 days
Other outcomes:
measure: Tumor reactive T cells
timeFrame: 3 months
Locations:
city: Heidelberg
country: Germany
facility: Department of Thoracic Surgery, Thoraxklinik, University Hospital Heidelberg
city: Heidelberg
country: Germany
facility: German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Seyer Safi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg
name: Hans Hoffmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: German Cancer Research Centre
name: Peter Huber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Safi 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.