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A Study of WSD0922-FU for Advanced Non-Small Cell Lung Cancer with C797S Mutation

This study is testing a new oral medication called WSD0922-FU for people with advanced non-small cell lung cancer (NSCLC). This medication is for those whose cancer has grown worse after taking a first-line treatment like Osimertinib, and whose tumors have a specific change in the EGFR gene called a C797S mutation. WSD0922-FU works by targeting this specific mutation. The study aims to see how well WSD0922-FU shrinks tumors (called Objective Response Rate or ORR) over about a year. We are looking for about 40 participants aged 18 or older who have NSCLC that has spread or cannot be removed by surgery or radiation. The current status of this study is unclear.

Study design
This is a Phase II, open-label study, meaning both you and your doctors will know which treatment you are receiving. It is a single-arm study, so all participants will receive WSD0922-FU. The study plans to enroll about 40 participants.
What's involved
You would take WSD0922-FU tablets by mouth for 21 days in each cycle. Tumor response will be measured every 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Objective Response Rate, will be measured for up to 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06868485

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Wayshine Biopharm, Inc.
~40 participants
Updated 2025-09-08 on ClinicalTrials.gov
What's tested:WSD0922-FU Tablets, Dose level AWSD0922-FU Tablets, Dose level B

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ORR
Measured over every 8 weeks, up to 1 year

Conditions

Non Small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaC797SSoluble Epidermal Growth Factor Receptor

Where it's being run

18 sites across 16 states
Shanghai Municipality2
New Aquitaine2
California1
Florida1
Michigan1
New Jersey1
Ohio1
Pennsylvania1

Study leadership

  • Adjei Alex A., PhD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Carina Yu
[email protected]
951-547-4692
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • ORRevery 8 weeks, up to 1 year

    proportion of patients with a best overall response of complete response or partial response