WSD0922-FU for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAdjei Alex A., PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Wayshine Biopharm, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

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.

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

I am 18 years old or older.

+6 more

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.

+7 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Dose level B selected from Phase I studyExperimental Treatment1 Intervention

BID

Group II: Dose level A selected from Phase I studyExperimental Treatment1 Intervention

BID