RecruitingPhase 1Phase 2NCT07206498

A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC

A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU in Combination With Osimertinib for Patients With Locally Advanced or Metastatic Non- Small Cell Lung Cancer


Sponsor

Wayshine Biopharm, Inc.

Enrollment

48 participants

Start Date

Oct 17, 2025

Study Type

INTERVENTIONAL

Summary

This is a Phase I/II, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination — WSD0922-FU plus osimertinib — for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that carries an EGFR mutation. Osimertinib is a standard EGFR-targeted therapy, and the study investigates whether WSD0922-FU can enhance or overcome resistance to it. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic NSCLC - Your cancer has been tested and found to carry an EGFR-sensitizing mutation - You have at least one measurable tumor on imaging - Your overall health is rated good (ECOG 0 or 1) - Your organs are functioning adequately - You are willing to use effective contraception if applicable - You have provided a blood or tissue sample for genetic testing **You may NOT be eligible if...** - You have received chemotherapy, radiation, or targeted therapy within 4 weeks before starting the study - You have previously received more than two EGFR-targeted therapies (for Part A of the study) - You have had recent major surgery or plan to have surgery during the trial - You are taking strong CYP3A4 inhibitors or inducers - Your prior treatment side effects have not recovered adequately Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOsimertinib (Tagrisso®)

Drug: Osimertinib Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI Drug: Osimertinib Given PO, 80mg, once daily

DRUGWSD0922-FU

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


Locations(1)

Shanghai East Hospital

Shanghai, China

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NCT07206498