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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (16)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

16 locations

Study team and timeline

Lead sponsor

Wayshine Biopharm, Inc.

Study start

Aug 18, 2025 Actual

Primary completion

Sep 30, 2027 Estimated

Study completion

Dec 31, 2027 Estimated

First posted

Mar 11, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts