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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 8, 2025 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.