A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
Recruiting · NCT06868485 · Interventional (participants receive a specific treatment) · Lead sponsor: Wayshine Biopharm, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
WSD0922-FU Tablets, Dose level AWSD0922-FU Tablets, Dose level B
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
18 locations listed across 8 US states.
- FOMAT Oncology - Oxnard, California, United States
- Cleveland Clinic Weston Hospital - Weston, Florida, United States
- Karmanos Cancer Institute - Detroit, Michigan, United States
- Hackensack Meridian Health-Southern Ocean Medical Center - Manahawkin, New Jersey, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- TxO Central/South, Texas Oncology -Central/South Texas - Austin, Texas, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- Fujian Provincial Cancer Hospital - Fuzhou, Fujian, China
- Wuhan Union Hospital - Wuhan, Hubei, China
- Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou - Rennes, Ille-et-Vilaine, France
- Centre Hospitalier Universitaire CHU De Limoges - Limoges, New Aquitaine, France
- CHU Bordeaux - Centre Francois Magendie - Pessac, New Aquitaine, France
- Centre Francois Baclesse - Caen, Normandy, France
- Shanghai East hospital - Shanghai, Shanghai Municipality, China
- Shanghai Pulmonary Hospital - Shanghai, Shanghai Municipality, China
- Tianjin Medical University Cancer Institute and Hospital - Tianjin, Tianjin Municipality, China
- CHU Toulon - Hopital Sainte Musse - Toulon, Var, France