Immune Boost In Non-Small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

— RadImmune  

Official title:

A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319408
• Other study ID #: S-576/ 2013
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: February 2020

Study information

• Verified date: May 2022
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Radiation:
• Preoperative radiation
Lobectomy for lung cancer following preoperative radiation

Locations

Country	Name	City	State
Germany	Department of Thoracic Surgery, Thoraxklinik, University Hospital Heidelberg	Heidelberg
Germany	German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg	Heidelberg

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Heidelberg	German Cancer Research Center, Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Klug F, Prakash H, Huber PE, Seibel T, Bender N, Halama N, Pfirschke C, Voss RH, Timke C, Umansky L, Klapproth K, Schäkel K, Garbi N, Jäger D, Weitz J, Schmitz-Winnenthal H, Hämmerling 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tumor reactive T cells	Frequencies of tumor reactive T cells in blood and bone marrow before radiotherapy and after surgery	3 months
Primary	Cluster of differentiation (CD)8+ T cells in resected NSCLC	Frequencies of CD8+ T cells in resected NSCLC tumors determined by immunohistochemistry	7 days
Secondary	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	7 days