Immune Boost In Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Preoperative radiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No radiation<br>Lobectomy for lung cancer without preoperative radiation | |
| Experimental: Preoperative radiation<br>Lobectomy for lung cancer with preoperative radiation | Radiation: Preoperative radiation<br>* Lobectomy for lung cancer following preoperative radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |