Immune Boost In Non-Small Cell Lung Cancer

NCT02319408 | Completed

• 1 other identifier: S-576/ 2013
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• T cell subtypes in resected NSCLC

  7 days

Other Outcomes (1)

• Tumor reactive T cells

  3 months

Study Arms (2)

No radiation

NO INTERVENTION

Lobectomy for lung cancer without preoperative radiation

Preoperative radiation

EXPERIMENTAL

Lobectomy for lung cancer with preoperative radiation

Radiation: Preoperative radiation

Interventions

Preoperative radiation RADIATION

Lobectomy for lung cancer following preoperative radiation

Preoperative radiation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• German Cancer Research Center: collaborator
• Heidelberg University: collaborator

Study Sites (2)

Department of Thoracic Surgery, Thoraxklinik, University Hospital Heidelberg

Heidelberg, 69126, Germany

Location

German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg

Heidelberg, 69126, Germany

Location

Related Publications (2)

• 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.

  PMID: 24209604 BACKGROUND

• 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.

  PMID: 26686362 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Seyer Safi, MD, PhD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

• Hans Hoffmann, MD, PhD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

• Peter Huber, MD, PhD

  German Cancer Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: December 18, 2014
• Study Start: April 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

DE (2)