A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
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.
Checked against the public recordLast updated Sep 8, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Wayshine Biopharm, Inc.
- Interventions being studied
- Drug: WSD0922-FU Tablets, Dose level A; Drug: WSD0922-FU Tablets, Dose level B
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- FOMAT OncologyOxnard, California
- Cleveland Clinic Weston HospitalWeston, Florida
- Karmanos Cancer InstituteDetroit, Michigan
- Hackensack Meridian Health-Southern Ocean Medical CenterManahawkin, New Jersey
- Cleveland ClinicCleveland, Ohio
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
- TxO Central/South, Texas Oncology -Central/South TexasAustin, Texas
- Virginia Cancer SpecialistsFairfax, Virginia
- Fujian Provincial Cancer HospitalFuzhou, Fujian
- Wuhan Union HospitalWuhan, Hubei
- Shanghai East hospitalShanghai, Shanghai Municipality
- Shanghai Pulmonary HospitalShanghai, Shanghai Municipality
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 8, 2025. Always confirm current availability with the study team.