A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWayshine Biopharm, Inc.

About 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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • WSD0922-FU Tablets, Dose level A
  • WSD0922-FU Tablets, Dose level B

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators