Testing WSD0922-FU Tablets in Lung Cancer With the C797S Mutation
Tests WSD0922-FU tablets in adults with lung cancer that grew after osimertinib.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
Key facts
- Where
- Austin, Cleveland, Fairfax, Manahawkin, Pittsburgh, and Weston, United StatesSee the 6 sites
- Phase
- Phase 2
Where in United States
- TxO Central/South, Texas Oncology -Central/South TexasAustin, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- Virginia Cancer SpecialistsFairfax, United StatesTaking people
- Hackensack Meridian Health-Southern Ocean Medical CenterManahawkin, United StatesTaking people
- UPMC Hillman Cancer CenterPittsburgh, United StatesTaking people
- Cleveland Clinic Weston HospitalWeston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Wayshine Biopharm, Inc.
- Trial code
- NCT06868485
- Record updated
- 10 November 2026
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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: 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; Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection; Any evidence of severe or uncontrolled systemic diseases; Past medical history of ILD; Known intracranial hemorrhage which is unrelated to tumor; Seizures requiring a change in anti-epileptic medications; Symptomatic brain complications that require urgent neurosurgical or medical intervention; Inadequate bone marrow reserve or organ function as demonstrated; Males and females of reproductive potential.