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Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids
Published on: November 22, 2021
Yifeixiaoji decoction as an adjunct to osimertinib therapy in advanced EGFR-mutated NSCLC: protocol for a randomized,
Qiuting Feng1,2,3, Changchang Sun2, Jiangyang He2
1Department of Oncology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Background:
Although EGFR-TKIs have substantially improved outcomes in EGFR-mutated advanced NSCLC, acquired resistance ultimately leads to treatment failure in most patients. Yifeixiaoji Decoction (YFXJD), a traditional Chinese herbal formulation, has shown promise as an adjunctive strategy; however, evidence from prospective clinical studies for this specific formula remains limited. We therefore designed this trial to assess whether YFXJD could prolong progression-free survival when added to standard osimertinib therapy in advanced NSCLC.
Methods:
A total of 200 patients with stage IV EGFR-mutant NSCLC will be enrolled in a randomized, double-blind, placebo-controlled trial and allocated 1:1 to receive standard osimertinib therapy combined with either YFXJD granules or matched placebo. The primary endpoints is progression-free survival. Key secondary endpoints include change in TCM syndrome score, objective response rate, quality of life (EORTC QLQ-C30/LC13), safety (NCI CTCAE v5.0), and exploratory peripheral blood biomarker analyses.
Expected Results:
This trial will provide prospective evidence regarding the efficacy and safety of YFXJD as an adjunct to osimertinib therapy in patients with advanced EGFR-mutant NSCLC and will determine whether this approach influences clinical outcomes.
Clinical Trial Registration:
https://itmctr.ccebtcm.org.cn, ITMCTR2025002306.