Actively Recruiting
A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer
Led by Wayshine Biopharm, Inc. · Updated on 2025-08-29
100
Participants Needed
12
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, open label, single-arm phase I/II clinical trial of WSD0922-FU for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with thrid-generation EGFR-TKI .
CONDITIONS
Official Title
A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old, any gender
- Diagnosis of locally advanced or metastatic non-small cell lung cancer confirmed by pathology
- Genetically tested and confirmed to carry EGFR sensitive mutations
- Blood samples provided during or after disease progression following the last EGFR TKI treatment
- Minimum life expectancy of 3 months or more
- At least one measurable tumor lesion according to RECIST version 1.1; prior radiotherapy-treated lesions cannot be used unless progression is clear
- Physical status (ECOG PS) score of 0 to 1
- Full organ function
- Fertile patients agree to use reliable contraception
- Voluntary signed informed consent provided before participation
You will not qualify if you...
- Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before starting study drug
- Previously received more than one EGFR-TKI inhibitor
- Received other unlisted clinical study drugs or treatments within 4 weeks before study drug administration
- Major organ surgery or significant trauma within 4 weeks before study drug administration, or require elective surgery during the trial
- Used strong CYP3A4 inhibitors or inducers within 7 days before first study drug use
- Known active brain metastasis or evidence of progression
- Other primary malignant tumors within 2 years before study drug administration
- Unrecovered adverse reactions from previous anti-tumor treatments to NCI-CTCAE v5.0 grade 1 or higher (except certain low-risk toxicities)
- Active skin/pressure ulcers, chronic leg ulcers, active gastric ulcers, or non-healing wounds
- History of severe allergies or allergies to study drug ingredients
- Severe infections requiring hospitalization or intravenous antibiotics at screening, or uncontrolled active infections within 4 weeks before administration
- Known active or suspected autoimmune diseases
- Known active ocular diseases such as wet age-related macular degeneration or diabetic retinopathy with macular edema
- HIV (HIV1/2 antibody) positive or syphilis antibody positive
- Interstitial lung disease
- History of severe cardiovascular diseases
- Unable to swallow medication or conditions affecting gastrointestinal absorption
- Need clinical intervention for pleural effusion or ascites unless stable for more than 2 weeks after drainage
- Known alcohol or drug dependence
- Mental disorders or poor compliance
- Pregnant or lactating women
- Other reasons deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230031
Actively Recruiting
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
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3
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510062
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4
He'nan Cancer Hospital
Zhengzhou, Henan, China, 450000
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5
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
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6
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
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7
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123
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8
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
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9
Sichuan Provincial Cancer Hospital
Chengdu, Sichuan, China, 610041
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10
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300202
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11
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006
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12
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China, 317000
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Research Team
L
lily liu, MD
CONTACT
W
Wei Zhong, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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