WSD0922-FU for Lung Cancer

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

Trial Summary

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.

What data supports the effectiveness of the drug WSD0922-FU for lung cancer?

The combination of 5-fluorouracil (5-FU) and low-dose cisplatin showed a 66.7% response rate in patients with advanced lung cancer, suggesting that similar treatments may be effective for lung cancer. ^{1 2 3 4 5}

What safety data exists for WSD0922-FU (5-FU) in humans?

5-FU, a component of WSD0922-FU, has been studied in various cancers, showing some side effects like low blood cell counts and digestive issues such as nausea and diarrhea. These side effects were generally mild to moderate in severity. ^{1 5 6 7 8}

How is the drug WSD0922-FU different from other lung cancer treatments?

The research does not provide specific information about WSD0922-FU, but it highlights the role of exosomal lncRNA FOXD3-AS1 in promoting resistance to 5-fluorouracil (5-FU) in lung cancer, suggesting that WSD0922-FU may involve novel strategies to overcome such resistance. ^{9 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

Adjei Alex A., PhD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[The efficacy and toxicity of the FUDR-based regimen in the treatment of advanced non-small cell lung cancer]. [2011]

2. Germany pubmed.ncbi.nlm.nih.gov

A phase II trial of FUdR in patients with advanced pancreatic cancer. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The Effect of ShenQi FuZheng Injection in Combination with Chemotherapy versus Chemotherapy Alone on the Improvement of Efficacy and Immune Function in Patients with Advanced Non-Small Cell Lung Cancer: A Meta-Analysis. [2021]

4. Japan pubmed.ncbi.nlm.nih.gov

[Combination chemotherapy of continuous infusion 5-fluorouracil and daily low-dose cisplatin in advanced gastrointestinal and lung adenocarcinoma]. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Impact of dihydropyrimidine dehydrogenase on 5-fluorouracil treatment in cancer patients. [2013]

6. England pubmed.ncbi.nlm.nih.gov

S-1 eliminates MDSCs and enhances the efficacy of PD-1 blockade via regulation of tumor-derived Bv8 and S100A8 in thoracic tumor. [2023]

7. China pubmed.ncbi.nlm.nih.gov

[Oxaliplatin in combination with LV5FU2 for advanced/metastatic gastric cancer-a multicenter study]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy of a new 5-fluorouracil derivative, BOF-A2, in advanced non-small cell lung cancer. A multi-center phase II study. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical and molecular responses in lung cancer patients receiving Romidepsin. [2014]

10. China pubmed.ncbi.nlm.nih.gov

Exosomal lncRNA FOXD3-AS1 upregulates ELAVL1 expression and activates PI3K/Akt pathway to enhance lung cancer cell proliferation, invasion, and 5-fluorouracil resistance. [2022]

11. China pubmed.ncbi.nlm.nih.gov

[Effect of recombinant human adenovirus p53 combined with cisplatin on the expression of human lung adenocarcinoma A549 cell gene]. [2013]

12. China pubmed.ncbi.nlm.nih.gov

Wenxia Changfu Formula () induces apoptosis of lung adenocarcinoma in a transplanted tumor model of drug-resistance nude mice. [2019]

13. China pubmed.ncbi.nlm.nih.gov

In vitro and in vivo inhibitory effect of the combination of Wenxia Changfu formula [see text] with cisplatin in non-small cell lung cancer. [2021]