RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-18
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06868485

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
  2. * Male or female aged ≥18 years old.
  3. * Histological or cytological confirmation diagnosis of NSCLC.
  4. * Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
  5. * Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.
  6. * Documented EGFR mutation .
  7. * Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks.
  8. * At least one lesion, not previously irradiated and not chosen for biopsy during the study.
  9. * Females should have evidence of non-childbearing potential.
  1. * 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.
  2. * Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.
  3. * Symptomatic brain complications that require urgent neurosurgical or medical intervention.
  4. * Any evidence of severe or uncontrolled systemic diseases.
  5. * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
  6. * Past medical history of ILD.
  7. * Inadequate bone marrow reserve or organ function as demonstrated.
  8. * Males and females of reproductive potential.
  9. * Known intracranial hemorrhage which is unrelated to tumor.
  10. * Seizures requiring a change in anti-epileptic medications.

Contacts and Locations

Study Contact

Carina Yu
CONTACT
951-547-4692
ling.yu@wayshinebiopharm.com
Wei Zhong
CONTACT
951-547-4692
wei.zhong@wayshinebiopharm.com

Principal Investigator

Adjei Alex A., PhD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

FOMAT Oncology
Oxnard, California, 93030
United States
Cleveland Clinic Weston Hospital
Weston, Florida, 33331
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Hackensack Meridian Health-Southern Ocean Medical Center
Manahawkin, New Jersey, 08050
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15235
United States
TxO Central/South, Texas Oncology -Central/South Texas
Austin, Texas, 78745
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Wayshine Biopharm, Inc.

  • Adjei Alex A., PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-08-18
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-08-18
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • C797S
  • BM
  • WSD0922-FU
  • NSCLC
  • EGFR

Additional Relevant MeSH Terms

  • Non Small Cell Lung Cancer