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

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Wayshine Biopharm, Inc. · Participants: 40 · Started: Aug 18, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06868485

Locations in the U.S.

CaliforniaFOMAT Oncology, Oxnard
FloridaCleveland Clinic Weston Hospital, Weston
MichiganKarmanos Cancer Institute, Detroit
New JerseyHackensack Meridian Health-Southern Ocean Medical Center, Manahawkin
OhioCleveland Clinic, Cleveland
PennsylvaniaUPMC Hillman Cancer Center, Pittsburgh
TexasTxO Central/South, Texas Oncology -Central/South Texas, Austin
VirginiaVirginia Cancer Specialists, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.