Various preliminary clinical trials have begun because of the growing awareness of uncommon genetic variants in the preclinical setting. Due to the rarity of these variants, it is necessary to screen a sizable population of patients, even if trial sample sizes tend to be modest. Next-generation sequencing (NGS) has made it possible to screen for numerous genetic variants at once. Umbrella clinical trials efficiently and rapidly screen and enroll patients for concurrent sub-studies utilizing NGS, allowing for the evaluation of several biomarkers and medicines at once.
Researchers planned a phase II clinical trial with an open-label, multi-center design (CTONG1702). Patients with non-small-cell lung cancer (NSCLC) at stages IIIB to IV (eighth AJCC) will be enrolled in an adaptive umbrella trial to assess the efficacy and safety of multiple biomarker-driven treatments, such as tyrosine kinase inhibitors (TKIs) and a programmed death-1 (PD-1) inhibitor. Patients will be enrolled in separate sub-studies depending on the outcomes of NGS and PD-L1 IHC analyses. Patients who do not meet the criteria for CTONG1702 will be enrolled in the real-world observational trial CTONG1705. The overarching goal of this study is to establish a comprehensive genomic database and investigate the link between genetic variants and clinical outcomes in patients with non-small cell lung cancer.
Patients with advanced NSCLC will participate in an adaptive umbrella trial to assess many targets and treatments (CTONG1702). The real-world study launched at the same time will also contribute to the knowledge used in therapeutic settings (CTONG1705).