Recruiting NCT06631989
A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WSD0922-FU.
- Who it may be relevant to
- Registry conditions: EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I/II Multicenter, Open Label, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of WSD0922-FU in the Treatment of Advanced Non-small Cell Lung Cancer
Overview
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 .
Detailed description
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ and dual EGFRm+/C797S+ receptor forms of EGFR with selectivity margin over wild-type EGFR. This study aims to explore the safety, tolerability, pharmacokinetic characteristics and efficacy of WSD0922-FU in patients with non-small cell lung cancer (NSCLC) with C797S mutation after first-line third-generation EGFR-TKI resistance.
Interventions
- Drug 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
Primary outcome measures
- ORR by IRC [Time frame: every 6 weeks, up to 1 year]
- PartA: To evaluate the safety of WSD0922-FU in patients with NSCLC [Time frame: 8 months]
- PartA: To evaluate the tolerability of WSD0922-FU in patients with NSCLC [Time frame: 8 months]
- PartA: To evaluate the Maximum Tolerated Dose (MTD) of WSD0922-FU in patients with NSCLC [Time frame: 8 months]
- PartA: Recommended Phase II Dose (RP2D) of WSD0922-FU in patients with NSCLC [Time frame: 8 months]
Secondary outcome measures (12)
- PK exposure parameter: Maximum Plasma Concentration (Cmax) [Time frame: 12 months]
- PK exposure parameter: Time To Maximum Plasma Concentration (Tmax) [Time frame: 12 months]
- PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Time With Last Measurable Concentration (AUC0-t) [Time frame: 12 months]
- PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Infinity (AUC0-∞) [Time frame: 12 months]
- PK exposure parameter: Terminal Elimination Half-Life (t½) [Time frame: 12 months]
- PK exposure parameter: Apparent Terminal Elimination Rate Constant (λz) [Time frame: 12 months]
- PK exposure parameter: Apparent Clearance (CL) [Time frame: 12 months]
- PK exposure parameter: Apparent volume of distribution (Vd) [Time frame: 12 months]
- PK exposure parameter: Mean Residence Time (MRT) [Time frame: 12 months]
- Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve（AUCss） [Time frame: 12 months]
- Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve from 0 to Infinity（AUC0-∞,ss） [Time frame: 12 months]
- Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve from 0 to Time t （AUC0-t,ss） [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Age 18-75 years old (including the threshold value), gender is not limited;
- 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
- Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 12 centers
- Anhui Provincial Hospital — Hefei
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
- He'nan Cancer Hospital — Zhengzhou
- Shandong Cancer Hospital — Jinan
- Shanghai Chest Hospital — Shanghai
- Shanghai East Hospital — Shanghai
- Shanghai Pulmonary Hospital — Shanghai
- … and 4 more centers
Identifiers
NCT: NCT06631989 · WSD0922-102