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

Sponsor
Wayshine Biopharm, Inc.
Study ID
NCT07206498
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib (Tagrisso®) — DRUG
    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
  • WSD0922-FU — DRUG
    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

Study Details

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

Key Dates

Start date
Oct 17, 2025
Status verified
Sep 2025
Primary completion
Oct 14, 2028
Completion
Oct 14, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation (WSD0922-FU and Osimertinib)
    Patients receive 80mg Osimertinib PO QD and WSD0922-FU PO QD. 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.
  • Experimental: Dose expansion (WSD0922-FU and Osimertinib)
    Patients receive 80mg Osimertinib PO QD and WSD0922-FU PO QD 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.

Primary Outcome Measure

PartA: To evaluate the safety of WSD0922-FU combined with Osimertinib in patients with NSCLC [ Time Frame: 12 months ]

Central Contacts

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