WSD0922-FU for Lung Cancer

Recruiting at 17 trial locations

Overseen By Wei Zhong

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wayshine Biopharm, Inc.

Must be taking: Osimertinib

Must not be taking: Investigational agents

Disqualifiers: Brain complications, Severe diseases, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: up to 1 year

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called WSD0922-FU for individuals with non-small cell lung cancer (NSCLC). It targets those whose cancer has worsened after taking Osimertinib, a common first-line treatment, and who have a specific genetic change called the C797S mutation in the EGFR gene. The trial will test two different doses to evaluate their effectiveness and safety. Suitable candidates for this trial include those with advanced lung cancer who can no longer undergo surgery or radiation and have experienced disease progression despite previous treatments. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in lung cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken any investigational agents or other anticancer drugs from a previous treatment within 14 days before starting the study.

Is there any evidence suggesting that WSD0922-FU is likely to be safe for humans?

Research has shown that WSD0922-FU has been tested for safety in earlier studies. Ongoing research indicates that most people can take it without serious problems. These initial studies aimed to find the best dose that patients can handle without major side effects.

In these studies, patients took WSD0922-FU orally. Researchers tested different doses to identify the safest one. Some side effects were noted, but they were usually manageable. This suggests that the treatment is reasonably safe for patients with lung cancer.

This background helps build confidence in its safety, but joining the trial remains a personal choice. It's important to discuss any concerns with the trial team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Unlike the standard treatments for lung cancer, which often include chemotherapy, targeted therapies, or immunotherapy, WSD0922-FU offers a new approach by utilizing a novel active ingredient. Researchers are excited about WSD0922-FU because it targets specific molecular pathways that are not addressed by existing treatments, potentially offering a more effective and personalized option. Additionally, its twice-daily (BID) dosing could enhance its effectiveness while maintaining manageable side effects. This innovative mechanism and dosing schedule give hope for improved outcomes for lung cancer patients.

What evidence suggests that WSD0922-FU might be an effective treatment for non-small cell lung cancer?

Research has shown that WSD0922-FU may help treat non-small cell lung cancer (NSCLC) in patients whose cancer worsened after initial treatment with osimertinib. In this trial, participants will receive WSD0922-FU at either Dose level A or Dose level B, selected from a Phase I study. Earlier studies indicated that all patients who received the treatment at certain doses experienced benefits, with their cancer either stopping growth or shrinking. Specifically, one study found that every patient who received higher doses had positive results. These early findings suggest that WSD0922-FU could be effective for people with this type of lung cancer, particularly those with the C797S mutation in the EGFR gene. ^{1 4 5 6 7}

Who Is on the Research Team?

Adjei Alex A., PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced non-small cell lung cancer that worsened after first-line Osimertinib treatment and have a specific mutation (C797S) in their cancer. They must be relatively healthy, not planning to have children, and haven't had certain severe illnesses or unresolved side effects from previous treatments.

Inclusion Criteria

My cancer has a known EGFR mutation.

Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses

My lung cancer diagnosis was confirmed through lab tests.

Exclusion Criteria

I have no major side effects from previous treatments.

I have a history of interstitial lung disease.

My bone marrow or organs are not functioning well.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive WSD0922-FU for advanced NSCLC with C797S mutation

up to 1 year

Visits every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• WSD0922-FU

Trial Overview The study tests different doses of WSD0922-FU tablets on patients with a particular type of lung cancer. It's an open-label Phase II trial, meaning everyone knows what treatment they're getting, and there's no comparison group.

How Is the Trial Designed?

Group I: Dose level B selected from Phase I study Experimental Treatment 1 Intervention

BID

Group II: Dose level A selected from Phase I study Experimental Treatment 1 Intervention

BID

Who Is Running the Clinical Trial?

Wayshine Biopharm, Inc.

Lead Sponsor

Trials

3

Recruited

200+

Published Research Related to This Trial

The OXA-LV5FU2 chemotherapy regimen demonstrated a high overall response rate of 42.5% in patients with advanced gastric cancer, with a median overall survival of 8 months, indicating its efficacy in treating this condition.

The treatment was associated with mild toxicity, with only 16.3% of patients experiencing severe neutropenia and no severe peripheral neuropathy or treatment-related deaths, suggesting it can be safely administered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oxaliplatin in combination with LV5FU2 for advanced/metastatic gastric cancer-a multicenter study]. Jin, ML., Chen, Q., Cheng, FQ., et al.[2018]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS8661

A multicenter, open-label, single-arm phase I/II study to ... An ongoing phase 1/2, open-label, multicenter trial evaluating the efficacy and safety of WSD0922-FU in patients with EGFR C797Sm+ NSCLC in China.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06868485

A Study to Assess the Efficacy of WSD0922-FU in Patients ... 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

3. sciencedirect.com sciencedirect.com/science/article/pii/S1556086425019859

P3.12.73 Phase I/II Study on WSD0922-FU in EGFR ... Results. All 42 patients received treatment at the time of data cutoff (Jul 31, 2025). For all evaluable patients in efficacy set (n = 33) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10639976/

CTNI-03. EFFICACY OF WSD0922-FU IN OSIMERTINIB ... Among patients with NSCLC treated at MTD or higher dose levels and with available response data, 100% (5/5) of patients demonstrated clinical benefit (SD + PR) ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT421300

Initial report from dose escalation cohort. WSD0922-Fu was orally administered, and dose escalated in cohorts based on a standard 3+3 design to determine the maximum tolerated dose (MTD). Toxicities were ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07206498

A Study to Evaluate Safety and Efficacy of WSD0922-FU ... 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 ...

7. reporter.nih.gov reporter.nih.gov/project-details/10479857

kizilbash, sani haider The clinical trial proposed in this research study will determine the safety of WSD0922-FU in patients with brain cancers and will provide valuable data on how ...