RecruitingNon Small Cell Lung Cancer
A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Wayshine Biopharm, Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
California
Oxnard
Florida
Weston
Michigan
Detroit
New Jersey
Manahawkin
Ohio
Cleveland
Pennsylvania
Pittsburgh
Texas
Austin
Virginia
Fairfax
Source: ClinicalTrials.gov · NCT06868485 · last updated 2025-09-08