Actively Recruiting
A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
Led by Wayshine Biopharm, Inc. · Updated on 2025-09-08
40
Participants Needed
18
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent given before any study-specific procedures
- Male or female aged 18 years or older
- Diagnosis of non-small cell lung cancer confirmed by tissue or cell analysis
- Locally advanced or metastatic NSCLC not suitable for curative surgery or radiotherapy
- Disease progression while on continuous first-line Osimertinib treatment
- Documented EGFR mutation present
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- At least one measurable lesion that has not been previously irradiated or selected for biopsy during the study
- Females must have evidence of non-childbearing potential
You will not qualify if you...
- Use of investigational agents or other anticancer drugs within 14 days before starting study treatment
- Unresolved side effects from prior therapy worse than CTCAE Grade 1
- Symptomatic brain complications needing urgent medical or neurosurgical care
- Severe or uncontrolled systemic diseases
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow tablets, or significant past bowel surgery
- History of interstitial lung disease (ILD)
- Inadequate bone marrow reserve or organ function
- Males or females who can conceive children
- Known intracranial hemorrhage unrelated to tumor
- Seizures requiring changes in anti-epileptic medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
FOMAT Oncology
Oxnard, California, United States, 93030
Actively Recruiting
2
Cleveland Clinic Weston Hospital
Weston, Florida, United States, 33331
Actively Recruiting
3
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
4
Hackensack Meridian Health-Southern Ocean Medical Center
Manahawkin, New Jersey, United States, 08050
Actively Recruiting
5
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
6
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15235
Actively Recruiting
7
TxO Central/South, Texas Oncology -Central/South Texas
Austin, Texas, United States, 78745
Actively Recruiting
8
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
9
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
10
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
11
Shanghai East hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
12
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
13
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300202
Actively Recruiting
14
Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
Rennes, Ille-et-Vilaine, France, 35000
Actively Recruiting
15
Centre Hospitalier Universitaire CHU De Limoges
Limoges, New Aquitaine, France, 87042
Actively Recruiting
16
CHU Bordeaux - Centre Francois Magendie
Pessac, New Aquitaine, France, 33604
Actively Recruiting
17
Centre Francois Baclesse
Caen, Normandy, France, 14000
Actively Recruiting
18
CHU Toulon - Hopital Sainte Musse
Toulon, Var, France, 83100
Actively Recruiting
Research Team
C
Carina Yu
CONTACT
W
Wei Zhong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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