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

A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation

Phase 2 Interventional Wayshine Biopharm, Inc. · NCT06868485

This trial tests whether the oral drug WSD0922-FU can help adults with advanced non-small cell lung cancer whose tumors developed the C797S mutation after first-line osimertinib.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment40 (estimated)
Ages18 Years and up
SexAll
SponsorWayshine Biopharm, Inc. Industry-sponsored
Drugs / interventionsOsimertinib
Locations18 sites (Oxnard, California and 17 other locations)
Trial IDNCT06868485 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed locally advanced or metastatic NSCLC, documented EGFR mutation including C797S, radiographic progression on first-line osimertinib, ECOG 0–1, and at least one measurable lesion are appropriate candidates.

Not a fit: Patients who do not have the C797S resistance mutation, who have unresolved significant toxicities from prior therapy, recent other investigational treatments, or poor performance status are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, WSD0922-FU could provide a new targeted option to control tumor growth in patients who develop C797S-mediated resistance after osimertinib.

How similar studies have performed: Preclinical and early-phase work on next-generation EGFR inhibitors targeting C797S has shown promise, but clinical success in this specific resistance setting remains limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Oxnard, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non Small Cell Lung CancerC797SBMWSD0922-FUNSCLCEGFR
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.