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Clinical Trials in China / NCT06868485
Recruiting Phase 2

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

NCT06868485 · tracked via the Priya Life Science China tracker
Sponsor
Wayshine Biopharm, Inc.
Phase
Phase 2
Started
2025-08-18
Last updated
2025-09-08

Condition(s) studied

Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

WSD0922-FU Tablets, Dose level AWSD0922-FU Tablets, Dose level B

WSD0922-FU Tablets, Dose level A: Oral, 21 days in each cycle

WSD0922-FU Tablets, Dose level B: Oral, 21 days in each cycle

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion criteria: * Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses. * Male or female aged ≥18 years old. * Histological or cytological confirmation diagnosis of NSCLC. * Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy. * Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment. * Documented EGFR mutation . * Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks. * At least one lesion, not previously irradiated and not chosen for biopsy during the study. * Females should have evidence of non-childbearing potential. Exclusion criteria: * Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment. * Any unresolved toxicities from prior therapy greater than CTCAE Grade 1. * Symptomatic brain complications that require urgent neurosurgical or medical intervention. * Any evidence of severe or uncontrolled systemic diseases. * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection. * Past medical history of ILD. * Inadequate bone marrow reserve or organ function as demonstrated. * Males and females of reproductive potential. * Known intracranial hemorrhage which is unrelated to tumor. * Seizures requiring a change in anti-epileptic medications.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
FOMAT Oncology Oxnard California Recruiting
Cleveland Clinic Weston Hospital Weston Florida Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Hackensack Meridian Health-Southern Ocean Medical Center Manahawkin New Jersey Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
TxO Central/South, Texas Oncology -Central/South Texas Austin Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Fujian Provincial Cancer Hospital Fuzhou Fujian Recruiting
Wuhan Union Hospital Wuhan Hubei Recruiting
Shanghai East hospital Shanghai Shanghai Municipality Recruiting
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality Recruiting
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality Recruiting
Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou Rennes Ille-et-Vilaine Recruiting
Centre Hospitalier Universitaire CHU De Limoges Limoges New Aquitaine Recruiting
CHU Bordeaux - Centre Francois Magendie Pessac New Aquitaine Recruiting
Centre Francois Baclesse Caen Normandy Recruiting
CHU Toulon - Hopital Sainte Musse Toulon Var Recruiting

More Wayshine Biopharm, Inc. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06868485 on ClinicalTrials.gov ↗ ← All trials in China