RecruitingPhase 1Phase 2NCT06631989

A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer

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


Sponsor

Wayshine Biopharm, Inc.

Enrollment

100 participants

Start Date

Sep 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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 .


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called WSD0922-FU in people with advanced non-small cell lung cancer (NSCLC) that has a specific type of mutation in the EGFR gene, and whose cancer has progressed after treatment with an EGFR-targeting drug (called a TKI). **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced or metastatic non-small cell lung cancer confirmed by biopsy - Your tumor has a known EGFR-sensitizing mutation - You have progressed on one prior EGFR TKI treatment (not more than one) - You have at least one measurable tumor on scans - Your overall health score (ECOG) is 0 or 1 **You may NOT be eligible if...** - You have had more than one prior EGFR TKI treatment - You have active brain metastases - You have significant heart disease, interstitial lung disease, or active infections - You are pregnant or breastfeeding - You are HIV positive or have a positive syphilis test 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

DRUGWSD0922-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(12)

Anhui Provincial Hospital

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

He'nan Cancer Hospital

Zhengzhou, Henan, China

Shandong Cancer Hospital

Jinan, Shandong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Sichuan Provincial Cancer Hospital

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06631989