Application of the RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for Advanced Non-small Cell Lung Cancer With Positive Driving Genes

What this Trial Is About

Researchers are studying how well the RecistTM criteria evaluate the effectiveness of targeted therapy in patients with advanced non-small cell lung cancer (NSCLC) who have positive driving genes like EGFR, ALK, and others. This study aims to improve and broaden the use of the RecistTM criteria to make tumor marker evaluations more objective and reliable compared to existing RECIST criteria. The research focuses on confirming the consistency and reliability of these criteria for better clinical efficacy assessment in this patient group. The study observes the application of RecistTM criteria alongside RECIST criteria to evaluate targeted therapies for NSCLC patients with positive driving genes. Researchers use statistical analysis to compare the efficacy evaluations between the two criteria, assess correlations with progression-free survival (PFS), and examine links with ctDNA levels. This is an observational study without intervention groups, focusing on the diagnostic use of the RecistTM criteria. Participants will have their treatment efficacy evaluated at the first, third, and sixth months after treatment begins, then every three months for up to one year. The study also tracks progression-free survival for up to 60 months. Evaluations include tumor marker levels, measurable lesions, and laboratory tests for blood, liver, and kidney function. Researchers monitor patients’ health status and tumor responses to better understand the criteria's applicability. The study began in November 2023 and will continue through December 2028.

RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC