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NCT Number: NCT02319408

Immune Boost In 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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Thoracic Surgery, Thoraxklinik, University Hospital Heidelberg, Heidelberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative radiation

Radiation

Lobectomy for lung cancer following preoperative radiation

Primary outcomes

  1. 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

Secondary outcomes

  1. T cell subtypes in resected NSCLC

    Time frame: 7 days

    Frequencies of CD3+, CD4+, CD45RO and Foxp3+ T cells in resected NSCLC tumors determined by immunohistochemistry and flow cytometry

Other outcomes

  1. Tumor reactive T cells

    Time frame: 3 months

    Frequencies of tumor reactive T cells in blood and bone marrow before radiotherapy and after surgery

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • German Cancer Research Center
  • Heidelberg University

Registry information

Official study title

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

Acronym: RadImmune

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2014
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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