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

Phase 2

Not yet recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: WSD0922-FU Tablets, Dose level A; Drug: WSD0922-FU Tablets, Dose level B

• Registration Number: NCT06868485
• Lead Sponsor: Wayshine Biopharm, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2025-02-22
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Study Start: 2025-05-31
• Primary Completion: 2027-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose level A selected from Phase I study	WSD0922-FU Tablets, Dose level A	BID
Dose level B selected from Phase I study	WSD0922-FU Tablets, Dose level B	BID

Primary Outcome Measures

Name	Time	Method
ORR	every 8 weeks, up to 1 year	proportion of patients with a best overall response of complete response or partial response

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DoR)	every 8 weeks, up to 1 year	proportion of patients with the time from the date of first documented response until the date of documented progression or death in the absence of disease progression
PFS	every 8 weeks, up to 1 year	proportion of patients with the time from randomization until the date of objective disease progression or death
Disease Control Rate (DCR)	every 8 weeks, up to 1 year	the percentage of patients who have a best overall response of CR or PR or SD
Overall Survival (OS)	24 months	the time from the date of randomization until death due to any cause
EORTC QLQ-C30 (HRQoL)	up to 24 months	PROs will be assessed using the EORTC QLQ-C30,changes in score compared to baseline will be evaluated.
EORTC QLQ-LC13 (HRQoL)	up to 24 months	PROs will be assessed using the EORTC QLQ-LC13, changes in score compared to baseline will be evaluated.
PRO CTCAE (HRQoL)	up to 24 months	To be assessed using the PRO CTCAE ,changes in symptoms compared to baseline will be evaluated.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States