WSD0922-FU plus osimertinib for EGFR-mutant advanced NSCLC with C797S or new brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 1/2 trial combines WSD0922-FU, a reversible inhibitor active against EGFR with C797S, with the third-generation EGFR inhibitor osimertinib to characterize safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Phase 1 will determine dose and safety while Phase 2 will further explore efficacy, including in patients with newly diagnosed CNS metastases carrying classical EGFR Del19 or L858R mutations. Eligible participants must have measurable disease per RECIST 1.1, ECOG performance status 0–1, and adequate organ function, with mandatory blood/tissue sampling. Outcomes will include adverse events, PK measures, and objective response in target lesions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥Age 18, gender is not limited;
* Locally advanced or metastatic NSCLC confirmed by pathology;
* Patients who have been genetically tested to carry EGFR sensitive mutations;
* Blood/Tissue samples must be provided for testing;
* 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 two EGFR-TKI inhibitors for part A;
* 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 drugs.
* 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.

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• Shanghai East Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: lily Liu, MD
• Email: lily.liu@wayshinebiopharm.com
• Phone: +8613818880308

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

  This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.

  Recruiting Phase 2 Cho Ray Hospital · Ho Chi Minh City · NCT07911449

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• NSCLC biomarker study using tumor and blood samples to link genetics with prognosis and immunotherapy response

  Researchers will test tumor tissue and blood from about 300 NSCLC patients to find genomic and immune markers that predict prognosis and response to immunotherapy.

  Recruiting at 20 sites Hellenic Cooperative Oncology Group · Limassol and 19 other locations · NCT07900581

• Osimertinib with Cyclosporine A for EGFR-mutant NSCLC

  This phase II study tests whether adding cyclosporine A to osimertinib helps people with EGFR-mutant metastatic NSCLC who still have detectable tumor DNA in blood.

  Recruiting Phase 2 NYU Langone Health · New York, New York · NCT07874490

• Wireless home prehabilitation for older adults with NSCLC awaiting lung surgery

  This study tests whether a personalized home exercise program guided by wearable devices can improve lung function for older NSCLC patients preparing for curative lung surgery.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT07809763

• First-line treatment with pembrolizumab, pemetrexed, and platinum with or without zoldonrasib for metastatic non-squamous NSCLC

  This trial tests whether adding zoldonrasib to standard pembrolizumab and platinum chemotherapy helps people with untreated metastatic non-squamous NSCLC that has a RAS G12D mutation.

  Recruiting at 4 sites Phase 3 Revolution Medicines, Inc. · Anchorage, Alaska and 3 other locations · NCT07777822

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.