A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer
NCT ID: NCT06631989
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2024-09-04
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose escalation (WSD0922-FU)
Patients receive WSD0922-FU PO QD on C0D1 to C0D3, then BID on C1D1 to C1D21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study.
WSD0922-FU
Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples
Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI
Drug: WSD0922-FU Given PO
Dose expansion (WSD0922-FU)
Patients receive WSD0922-FU PO BID on C1D1 to C1D21 using dosage selected from Dose escalation. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study.
WSD0922-FU
Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples
Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI
Drug: WSD0922-FU Given PO
Dose extension (WSD0922-FU)
Patients receive WSD0922-FU PO BID on C1D1 to C1D21 using RP2D. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study.
WSD0922-FU
Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples
Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI
Drug: WSD0922-FU Given PO
Interventions
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WSD0922-FU
Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples
Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI
Drug: WSD0922-FU Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Locally advanced or metastatic NSCLC confirmed by pathology;
* Patients who have been genetically tested to carry EGFR sensitive mutations;
* Blood samples must be provided for testing and must be taken during or after disease progression following the last EGFR TKI inhibitor treatment;
* Must have a minimum life expectancy of \>= 3 months;
* At least one measurable tumor lesion according to RECIST version 1.1; Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions.
* Physical Status (ECOG PS) score was 0-1;
* Have full organ function;
* Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ;
* Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily.
Exclusion Criteria
* Have previously received more than one EGFR-TKI inhibitor;
* Received other unlisted clinical study drugs or treatments within 4 weeks before the first administration.
* Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.
* Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drug.
* Known active brain metastasis or progression evidence.
* Other primary malignant tumors within 2 years before the first administration of the study drug.
* Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher to have no safety risks, such as hair loss, grade 2 peripheral neurotoxicity, and stable thyroid function after hormone replacement therapy).
* Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds.
* History of severe allergies, or allergies to any active or inactive ingredients of the study drug;
* Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration;
* Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema);
* Human immunodeficiency virus (HIV) (HIV1/2 antibody) positive, syphilis spirochete antibody positive .
* Patients with interstitial lung disease.
* History of severe cardiovascular diseases.
* Unable to orally swallow medication, or there is a condition that significantly affects gastrointestinal absorption as judged by the researcher;
* Clinical intervention is required for pleural effusion, ascites (excluding subjects who do not need drainage and have been stable for more than 2 weeks after drainage).
* Known alcohol or drug dependence.
* Mental disorders or poor compliance;
* Pregnant or lactating women;
* The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study.
18 Years
75 Years
ALL
No
Sponsors
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Wayshine Biopharm, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Caicun Zhou, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
He'nan Cancer Hospital
Zhengzhou, Henan, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Sichuan Provincial Cancer Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Anwen Xiong, MD
Role: primary
Other Identifiers
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WSD0922-102
Identifier Type: -
Identifier Source: org_study_id
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