Immune Boost In Non-Small Cell Lung Cancer (RadImmune)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02319408 |
Recruitment Status :
Completed
First Posted : December 18, 2014
Last Update Posted : May 23, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Radiation: Preoperative radiation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer |
Study Start Date : | April 2016 |
Actual Primary Completion Date : | February 2020 |
Actual Study Completion Date : | February 2020 |

Arm | Intervention/treatment |
---|---|
No Intervention: No radiation
Lobectomy for lung cancer without preoperative radiation
|
|
Experimental: Preoperative radiation
Lobectomy for lung cancer with preoperative radiation
|
Radiation: Preoperative radiation
Lobectomy for lung cancer following preoperative radiation |
- 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
- 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
- Tumor reactive T cells [ Time Frame: 3 months ]Frequencies of tumor reactive T cells in blood and bone marrow before radiotherapy and after surgery

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319408
Germany | |
Department of Thoracic Surgery, Thoraxklinik, University Hospital Heidelberg | |
Heidelberg, Germany, 69126 | |
German Cancer Research Centre and Clinic for Radiation Oncology of the University of Heidelberg | |
Heidelberg, Germany, 69126 |
Principal Investigator: | 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 |
Other Publications:
Responsible Party: | Dr. med. Seyer Safi, University Hospital Heidelberg |
ClinicalTrials.gov Identifier: | NCT02319408 |
Other Study ID Numbers: |
S-576/ 2013 |
First Posted: | December 18, 2014 Key Record Dates |
Last Update Posted: | May 23, 2022 |
Last Verified: | May 2022 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |