WSD0922-FU for advanced non-small cell lung cancer with the C797S mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, open-label, multicenter, single-arm trial enrolling patients with locally advanced or metastatic NSCLC that progressed on first-line osimertinib and whose tumors harbor the C797S EGFR mutation. Participants receive WSD0922-FU tablets at one of two dose levels with regular imaging and safety monitoring. The drug is a reversible EGFR inhibitor designed to target both sensitizing EGFR mutations and the C797S resistance mutation while sparing wild-type EGFR. The study includes patients with or without brain metastases and tracks response, disease control, and tolerability.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cleveland Clinic Weston Hospital
  Weston, Florida, United States Recruiting
• Hackensack Meridian Health-Southern Ocean Medical Center
  Manahawkin, New Jersey, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• UPMC Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting
• TxO Central/South, Texas Oncology -Central/South Texas
  Austin, Texas, United States Recruiting
• Virginia Cancer Specialists
  Fairfax, Virginia, United States Recruiting

Study contacts

• Principal investigator: Adjei Alex A., PhD — The Cleveland Clinic
• Study coordinator: Lily Liu
• Email: lily.liu@wayshinebiopharm.com
• Phone: 951-547-4692

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.