Study of Biomarkers to Predict and Guide Immunotherapy Treatment in Advanced Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the use of biomarkers to predict how patients with stage IIIB-IV non-small cell lung cancer NSCLC will respond to initial PD1 or PD-L1-based immunotherapy and to guide second-line treatment choices. This phase II trial aims to improve understanding of immunotherapy effects on tumor cells and immune response, as well as to develop personalized treatment strategies. The study focuses on patients with advanced NSCLC who have no sensitizing EGFR mutation or ALKROS1 alteration and are starting or have recently started FDA-approved PD1PDL1 immunotherapy with or without chemotherapy. Participants receive PDL1-based immunotherapy every three weeks with or without chemotherapy for up to 12 to 24 months as part of their first-line treatment. Depending on treatment response and circulating tumor DNA ctDNA levels, patients may discontinue or continue therapy and undergo monitoring or surveillance. For those whose cancer progresses, second-line treatments include combinations of tremelimumab and durvalumab given intravenously or adagrasib taken orally with bevacizumab given intravenously, depending on specific genetic mutations. Treatment cycles and durations vary by arm, with careful monitoring for disease progression or toxicity. Throughout the study, patients undergo regular blood sample collections, imaging scans including CT, MRI, or PET, and may have cerebrospinal fluid, ascites, pleural fluid, and tumor biopsies collected during routine care. Safety and treatment response are assessed through these evaluations, along with progression-free survival and overall survival measures. After treatment completion, participants are followed up at 30 days, then every 3 months in the first year, and every 6 months up to two years to monitor long-term outcomes.

Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial