NSCLC, Stage I Clinical Trial
Official title:
Combining SBRT and Immunotherapy in Early Stage NSCLC Patients Planned for Surgery: Exploring Safety and Immunological Proof of Principle.
This study aims to evaluate the safety and mechanisms of action of the trimodality treatment (radiotherapy, immunotherapy and surgery) in early-stage non-small cell lung cancer. Half of the patients will receive stereotactic ablative radiotherapy followed by 2 cycles of immunotherapy (pembrolizumab); the other half will not receive the immunotherapy treatment. After treatment, both groups will continue treatment according to guidelines and will undergo surgery (lobectomy).
An open label randomized exploratory study of the safety and mechanisms of action of combined
treatment with SBRT and immunotherapy (pembrolizumab, anti-PD1) for early stage NSCLC.
Intervention:
Patients will be randomized between SBRT with or without 2 cycles of pembrolizumab treatment
(starting on the first day of radiotherapy). The patients will undergo a lobectomy with hilar
and mediastinal lymph node dissection after SBRT +/- pembrolizumab treatment. Translational
research to explore the immune mechanism of action will include biological imaging with
immuno-PET (positron emission tomography). Expression rates and activation states of immune
effector subsets will be assessed in tumor core biopsy specimens, peripheral blood and tumor
draining lymph nodes (TDLNs) by means of fine needle aspirates of TDLNs.
Main study parameters/endpoints:
To assess the safety of combined SBRT and pembrolizumab treatment in early stage NSCLC and to
identify the immunological mechanism of action.
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