Abstract
BackgroundWith rare genetic variations having been increasingly recognized at a preclinical stage, a variety of early-phase clinical trials have been launched. Due to the low incidence rate of these variations, although the sample size of trials are small, it still needs a large number of patients for screening. With the advent of next-generation sequencing (NGS), multiple genetic variations can be detected simultaneously. Multiple biomarkers and agents can be evaluated using umbrella clinical trials, which rapidly and effectively screen and enroll patients for parallel sub-studies using NGS. Patients and MethodsWe designed an open-label, multi-center, phase II clinical trial CTONG1702. This is an adaptive umbrella trial that will evaluate the efficacy and safety of several biomarker-driven agents, including tyrosine kinase inhibitors (TKIs) and a PD-1 inhibitor, in stage IIIB to IV patients (eighth AJCC) with non-small-cell lung cancer (NSCLC) patients. Patients will be enrolled in parallel sub-studies based on the results of NGS and PD-L1 IHC analysis. Patients who are not eligible for CTONG1702 will be enrolled in the observational real-world study CTONG1705. This study aims to develop a large-scale genomic database and explore the relationship between genetic variations in NSCLC patients and clinical outcomes. ConclusionsThe adaptive umbrella trial will evaluate multi-targets and multi-drugs in advanced NSCLC patients (CTONG1702). In addition, the simultaneously initiated real-world study will provide additional data for clinical practice (CTONG1705).
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.