Wednesday, October 30, 2019 The CCTG BR36 trial: A Biomarker-Directed, Open Label, Multi-Centre Phase II Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients with Non-Small Cell Lung Cancer, has been centrally activated. The standard or usual treatment for this disease is pembrolizumab given by needle every three weeks. This study will be done in two stages. The purpose of stage one of the study is to find out if we can use blood tests to see how the cancer is responding to treatment with pembrolizumab. A second stage of the study will take place once stage one is completed. In stage two, blood tests will be used to help determine if patients whose cancer does not seem to be getting better on treatment with pembrolizumab, would do better on a different treatment. Eligibility: Histologically or cytologically confirmed stage IV EGFR and ALK negative NSCLC or T4NX (Stage IIIB) with nodule in ipsilateral lobe if patient not a candidate for chemotherapy + radiation. PD-L1 expression TPS 50% or more. Eligible to receive treatment with pembrolizumab. ECOG 0 or 1. Measurable disease per RECIST 1.1. Available tissue block from primary or metastatic tumor. Mandatory blood collection for ctDNA analysis. MAIN EXCLUSION CRITERIA: Active or prior autoimmune disorders. Active brain or leptomeningeal metastases. Untreated or uncontrolled cardiovascular conditions. Objectives: Primary: Identify optimal time points for molecular response as assessed by ctDNA assay and validate concordance of molecular response with radiologic response. Secondary: evaluate time to molecular response, correlate molecular response to RECIST response, PFS and OS,to explore degree of ctDNA reduction with clinical outcomes. Tertiary: collect archival tumour tissue for translational research studies. For more information please visit the trial page: BR36
