Phase II Study of WSD0922-FU for Adults With Advanced or Metastatic Non-Small Cell Lung Cancer Having EGFR C797S Mutation After Osimertinib Treatment

What this Trial Is About

Researchers are evaluating WSD0922-FU in a Phase II, open-label, multicenter study for patients with locally advanced or metastatic non-small cell lung cancer NSCLC whose disease has progressed after first-line treatment with Osimertinib and whose tumors have a C797S mutation in the EGFR gene. This mutation causes resistance to prior treatments, and the study aims to assess safety and effectiveness of this new drug in this specific patient group. WSD0922-FU is an oral drug taken in 21-day cycles, administered twice daily BID at one of two dose levels selected from earlier studies. The drug targets specific EGFR mutations including the resistant C797S mutation. This single-arm study will treat all participants with WSD0922-FU and monitor responses over time. Participants will be closely monitored with assessments every 8 weeks for up to one year to measure tumor response, disease control, progression-free survival, and quality of life using standardized questionnaires. Survival outcomes will be followed for up to 24 months. Safety and side effects will also be recorded throughout the study. The study duration and follow-up are designed to thoroughly evaluate the drugs effects in this advanced NSCLC population.

A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer