NCT06868485

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

A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Wayshine Biopharm, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.

Detailed description

WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+/C797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and efficacy of WSD0922-FU in patients with advanced NSCLC whose cancers have progressed with or without brain metastasis following a first-line Osimertinib treatment.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	WSD0922-FU Tablets, Dose level A	Oral, 21 days in each cycle
DRUG	WSD0922-FU Tablets, Dose level B	Oral, 21 days in each cycle

Timeline

• Start date: 2025-08-18
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2025-03-11
• Last updated: 2025-09-08

Locations

18 sites across 3 countries: United States, China, France

Regulatory

• FDA-regulated drug study