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

NCT06868485 · Wayshine Biopharm, Inc.
In plain English

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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
About this study
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.
Eligibility criteria
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 design
Enrollment target: 40 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-18
Estimated completion: 2027-12-31
Last updated: 2025-09-08
Interventions
Drug: WSD0922-FU Tablets, Dose level ADrug: WSD0922-FU Tablets, Dose level B
Primary outcomes
  • ORR (every 8 weeks, up to 1 year)
Sponsor
Wayshine Biopharm, Inc. · industry
Contacts & investigators
ContactCarina Yu · contact · ling.yu@wayshinebiopharm.com · 951-547-4692
ContactWei Zhong · contact · wei.zhong@wayshinebiopharm.com · 951-547-4692
InvestigatorAdjei Alex A., PhD · principal_investigator, The Cleveland Clinic
All locations (18)
FOMAT OncologyRecruiting
Oxnard, California, United States
Cleveland Clinic Weston HospitalRecruiting
Weston, Florida, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Hackensack Meridian Health-Southern Ocean Medical CenterRecruiting
Manahawkin, New Jersey, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
TxO Central/South, Texas Oncology -Central/South TexasRecruiting
Austin, Texas, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Fujian Provincial Cancer HospitalRecruiting
Fuzhou, Fujian, China
Wuhan Union HospitalRecruiting
Wuhan, Hubei, China
Shanghai East hospitalRecruiting
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary HospitalRecruiting
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and HospitalRecruiting
Tianjin, Tianjin Municipality, China
Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de PontchaillouRecruiting
Rennes, Ille-et-Vilaine, France
Centre Hospitalier Universitaire CHU De LimogesRecruiting
Limoges, New Aquitaine, France
CHU Bordeaux - Centre Francois MagendieRecruiting
Pessac, New Aquitaine, France
Centre Francois BaclesseRecruiting
Caen, Normandy, France
CHU Toulon - Hopital Sainte MusseRecruiting
Toulon, Var, France