Screening Study to Determine Biomarker Status in Patients with Advanced Non-Small-Cell Lung Cancer

Lung cancer is a malignant disease in which cells in the lungs multiply uncontrollably and can destroy healthy tissue. Non-small cell lung cancer (NSCLC) is the most common form of lung cancer and generally grows more slowly than small cell lung cancer. In advanced stages of the disease (Stage II and beyond), surgical removal of the tumor alone is often no longer sufficient. In such cases, additional treatment must be considered in conjunction with surgery, or an alternative therapy that does not involve tumor removal must be planned. Immunotherapy represents one such treatment option. This treatment is based on activating the immune system, thereby helping it to recognize and fight cancer cells. Determining so-called biomarkers is of great importance for selecting the appropriate immunotherapy. These include genetic information (gene mutations) and surface characteristics of the cancer cells (e.g., PD-L1 status). However, this testing has not yet been made widely available in clinical practice for all surface characteristics. The goal of this Phase 2 study is to screen patients for the presence of specific biomarkers and to assess their suitability for further studies and personalized immunotherapy. As part of the study, patients will be screened for the presence of various biomarkers as potential targets using a tissue sample taken from the tumor. Based on this information, their eligibility for a further treatment study conducted by Roche can then be assessed. This assessment will continue for up to 10 years. No standalone therapy is being tested as part of this screening study. Patients 18 years of age or older with non-small cell lung cancer (NSCLC) at stage II or higher are eligible to participate in this screening study.