Cancer types
  • Lung
Title of study
Immune profiling of stage III non-small cell lung cancer patients treated with concurrent chemoradiation and adjuvant durvalumab: A prospective observational phase II trial
Version Number
Approval Date 
4, 2 December 2020
Short Title
IPON-1
Study site
Principle Investigator
Investigator Maastro
Prof. Dr. D. De Ruysscher
Sponsor
MAASTRO
Trial registry
Objectives 

The main objective of the trial is to test if the combination of (SAB)R and the immunocytokineL19-IL2 has clinical meaningfulactivity in patients with limited metastatic non-small cell lung cancer (NSCLC): (≤10 sites, WHO 0-1). The expected activity is a systemic immune response preventing disease progression and resulting in an improvement of progression-freesurvival (PFS)at 1.5 year.

Primary Endpoint 

•Profiling immune changes between baseline, one week of radiotherapy, end of radiotherapy and three months of durvalumab.
•Identification of differentially expressed proteins at all time points
•Identification of differentially expressed genes at all time points
•Investigate the functional immunological activity of serum samples at all time points
•Investigate the immune cell composition in blood samples from all time points

Secondary Endpoints 

•Progression-free survival
•Overall survival
•Toxicity during and after concurrent chemoradiation, also in relation to the irradiated bone marrow volume: o Lymphopenia and subtypes o Neutropenia o Anemia o Other toxicity o Dose and intensity of chemotherapy (i.e. dose delays/reductions)
•Toxicity of durvalumab and chemoradiation treatment: o Pneumonitis o Cardiac side effects o Cognitive side effects – Incidence and severity of adverse events (Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 and patient reported outcome (PRO)-CTCAE)
•Identify immune changes that are distinct for proton therapy compared with photon therapy
•Cardiac function: BNP, Troponins, ECG, blood pressure
•Neurocognitive function: HVALT-R, trail making test, controlled oral word association, and MOS – Obtaining tumor material from standard diagnostic material for translational purposes
•Genetic and phenotypic tumor heterogeneity of the tumor biopsy – Chest-CT, FDG-PET, brain imaging MRI/CT scans
•Circulating tumor DNA to determine minimal residual disease
•LC3/GABARAPL protein family in the blood

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