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RECRUITING
NCT07206498
PHASE1/PHASE2

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

Sponsor: Wayshine Biopharm, Inc.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-10-17

Completion Date

2029-10-14

Last Updated

2025-11-28

Healthy Volunteers

No

Interventions

DRUG

Osimertinib (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

DRUG

WSD0922-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