RecruitingPhase 2NCT06868485

A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer

A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation

Sponsor

Wayshine Biopharm, Inc.

Enrollment

40 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new targeted drug (WSD0922-FU) for patients with non-small cell lung cancer (NSCLC) that has developed a specific resistance mutation called C797S after treatment with third-generation EGFR inhibitors like osimertinib. **You may be eligible if...** - You are 18 or older - You have confirmed NSCLC that is locally advanced or metastatic - Your tumor has an EGFR mutation and has developed the C797S resistance mutation (confirmed by a tissue or blood test) - Your cancer progressed on a previous EGFR-targeted therapy (such as osimertinib) **You may NOT be eligible if...** - You have active brain metastases that are unstable or untreated - You have had prior treatment with a drug specifically targeting the C797S mutation - You have serious heart problems (e.g., prolonged QT interval) - You are pregnant or breastfeeding 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGWSD0922-FU Tablets, Dose level A

Oral, 21 days in each cycle

DRUGWSD0922-FU Tablets, Dose level B

Oral, 21 days in each cycle

Locations(18)

FOMAT Oncology

Oxnard, California, United States

Cleveland Clinic Weston Hospital

Weston, Florida, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Hackensack Meridian Health-Southern Ocean Medical Center

Manahawkin, New Jersey, United States

Cleveland Clinic

Cleveland, Ohio, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

TxO Central/South, Texas Oncology -Central/South Texas

Austin, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Wuhan Union Hospital

Wuhan, Hubei, China

Shanghai East hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou

Rennes, Ille-et-Vilaine, France

Centre Hospitalier Universitaire CHU De Limoges

Limoges, New Aquitaine, France

CHU Bordeaux - Centre Francois Magendie

Pessac, New Aquitaine, France

Centre Francois Baclesse

Caen, Normandy, France

CHU Toulon - Hopital Sainte Musse

Toulon, Var, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06868485

Related Trials

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer

NCT034128771 location

Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)

NCT066944541 location

A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)

NCT056578739 locations

A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

NCT06312137260 locations

Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

NCT06422143207 locations