Liquid Biopsy to Predict Responses to First-line Immunotherapy in Metastatic Non-small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating how liquid biopsy using circulating tumor DNA (ctDNA) can help predict responses to first-line immune checkpoint inhibitor therapy in patients with metastatic non-small cell lung cancer (NSCLC) who have not received prior treatment. Only patients whose tumor tissue shows at least one mutation on next-generation sequencing (NGS) will be enrolled to allow monitoring of these mutations in blood samples. The study is sponsored by Institut Curie and aims to assess treatment response based on ctDNA changes and CT-scan imaging. Patients will undergo NGS analysis on tumor tissue before starting treatment. Those with identified mutations will receive pembrolizumab, possibly combined with chemotherapy, as first-line treatment. Blood samples for ctDNA analysis will be collected at baseline, 3 weeks, 6 weeks, and then every 6 weeks. Blood immunomonitoring will occur before treatment, at 6 weeks, and at 18 weeks, with an extra sample if treatment stops early. CT-scans will be performed every 9 weeks as part of routine care. Optional blood samples may be taken to assess lymphocyte activity. During the study, participants will have regular blood draws and imaging assessments to monitor treatment impact. Researchers will measure changes in ctDNA mutant allele levels at 6 weeks to evaluate response using RECIST 1.1 criteria. Secondary outcomes include survival rates, progression-free survival, response to second-line treatments, and adverse events. Total study duration includes follow-up until the end of the study, with ongoing CT-scan and blood monitoring integrated into care.

LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer. LIBERTY LUNG