Validation of the TheraSure CNI-Monitor Under Immuno-checkpoint-therapy (Hereinafter: "Immunotherapy") in NSCLC in Palliative Therapy

This is a prospective, non-interventional, national study planned at three centers for patients with non-curative NSCLC receiving immunotherapy. At present, PD-L1 expression or tumor mutation burden serve as surrogate parameters for response to immunotherapy. However, the problem for clinicians is that not all patients with positive findings respond to this form of therapy. Cell-free DNA (cf-DNA) can be detected in blood plasma. Tumor cells almost always have chromosomal instabilities (or "copy-number variations" (CNV)), which can be detected using next-generation sequencing (NGS), also in the cf-DNA. These CNV can be quantified and given as a cf-DNA copy number instability score (CNI value). TheraSure CNI-Monitor is a highly sensitive method that can detect as little as 0.5% tumor DNA in plasma. In preliminary work in a cohort of 56 patients with various types of cancer (including: b