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

August 30, 2025 updated by: Wayshine Biopharm, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Provincial Cancer Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital
        • Contact:
          • Principal Investigator
          • Phone Number: 86-27-85726300
          • Email: xhzzdxr@126.com
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
          • Principal Investigator
          • Phone Number: 86-21-65115006
          • Email: fywu@163.com
      • Shanghai, Shanghai Municipality, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300202
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
  • France
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35000
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
        • Contact:
    • Normandy
      • Caen, Normandy, France, 14000
    • Nouvelle-Aquitaine
      • Limoges, Nouvelle-Aquitaine, France, 87042
        • Recruiting
        • Centre Hospitalier Universitaire CHU De Limoges
        • Contact:
      • Pessac, Nouvelle-Aquitaine, France, 33604
        • Recruiting
        • CHU Bordeaux - Centre Francois Magendie
        • Contact:
    • Var
  • United States
    • California
      • Oxnard, California, United States, 93030
        • Recruiting
        • FOMAT Oncology
        • Contact:
    • Florida
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Weston Hospital
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
    • New Jersey
      • Manahawkin, New Jersey, United States, 08050
        • Recruiting
        • Hackensack Meridian Health-Southern Ocean Medical Center
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15235
        • Recruiting
        • UPMC Hillman Cancer Center
        • Contact:
    • Texas
      • Austin, Texas, United States, 78745
        • Recruiting
        • TxO Central/South, Texas Oncology -Central/South Texas
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
  • Male or female aged ≥18 years old.
  • Histological or cytological confirmation diagnosis of NSCLC.
  • Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
  • Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.
  • Documented EGFR mutation .
  • Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks.
  • At least one lesion, not previously irradiated and not chosen for biopsy during the study.
  • Females should have evidence of non-childbearing potential.

Exclusion criteria:

  • Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
  • Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.
  • Symptomatic brain complications that require urgent neurosurgical or medical intervention.
  • Any evidence of severe or uncontrolled systemic diseases.
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
  • Past medical history of ILD.
  • Inadequate bone marrow reserve or organ function as demonstrated.
  • Males and females of reproductive potential.
  • Known intracranial hemorrhage which is unrelated to tumor.
  • Seizures requiring a change in anti-epileptic medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose level A selected from Phase I study
BID
Drug: WSD0922-FU Tablets, Dose level A
Oral, 21 days in each cycle
Other Names:
  • WSD0922
Experimental: Dose level B selected from Phase I study
BID
Drug: WSD0922-FU Tablets, Dose level B
Oral, 21 days in each cycle
Other Names:
  • WSD0922

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: every 8 weeks, up to 1 year
proportion of patients with a best overall response of complete response or partial response
every 8 weeks, up to 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayshine Biopharm, Inc.

Investigators

  • Principal Investigator: Adjei Alex A., PhD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 22, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

August 30, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS2202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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