Study on the Effectiveness of WSD0922-FU in Patients with Advanced Non-Small Cell Lung Cancer with C797S Mutation

Sponsor: Wayshine Biopharm, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06868485

Provider View

This clinical trial is testing a new drug, WSD0922-FU, to see if it can help patients with advanced non-small cell lung cancer (NSCLC) whose cancer has worsened after treatment with Osimertinib and have a specific genetic mutation called C797S.

Patient Parameters

Program Overview

The study is a Phase II trial, meaning it focuses on the effectiveness and safety of WSD0922-FU in patients with advanced non-small cell lung cancer (NSCLC) that has progressed after initial treatment with Osimertinib. The trial is open to patients whose tumors have a specific mutation in the EGFR gene, known as C797S, which can make the cancer resistant to first-line treatments.

Description

WSD0922-FU is a new drug designed to target specific mutations in the EGFR gene found in some lung cancers. These mutations can make the cancer resistant to standard treatments like Osimertinib. This study aims to see if WSD0922-FU can effectively treat patients with advanced non-small cell lung cancer (NSCLC) who have these mutations and whose cancer has progressed despite previous treatment. The trial will evaluate how safe and effective WSD0922-FU is for these patients, including those with or without brain metastases.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate in the study.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of non-small cell lung cancer (NSCLC).
  • Cancer must be advanced or has spread and cannot be treated with surgery or radiotherapy.
  • Cancer must have worsened while on previous treatment with Osimertinib.
  • Must have a specific EGFR mutation.
  • Must be in good general health with an ECOG score of 0 or 1 and expected to live at least 12 more weeks.
  • Must have at least one tumor that can be measured and has not been treated with radiation or chosen for biopsy during the study.
  • Women must not be able to become pregnant.

Exclusion Criteria

  • Have taken any experimental drugs or other cancer treatments within 14 days before starting the study treatment.
  • Have any side effects from previous treatments that are not resolved to a mild level.
  • Have brain issues that need urgent medical treatment.
  • Have any severe or uncontrolled diseases.
  • Have severe nausea, vomiting, digestive issues, or cannot swallow pills.
  • Have a history of lung diseases like interstitial lung disease (ILD).
  • Have poor bone marrow or organ function.
  • Are able to have children.
  • Have had bleeding in the brain not related to the tumor.
  • Have seizures that require changes in medication.

Locations

FACILITYZIPCITYSTATE
Cleveland Clinic44195ClevelandOhio

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