A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWayshine Biopharm, Inc.

About this trial

This is a Phase I/II, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation

Eligibility criteria

Qualifiers

≥Age 18, gender is not limited;

Locally advanced or metastatic NSCLC confirmed by pathology;

Patients who have been genetically tested to carry EGFR sensitive mutations;

Blood/Tissue samples must be provided for testing;

Disqualifiers

Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.

Have previously received more than two EGFR-TKI inhibitors for part A;

Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.

Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drugs.

Trial design

Treatments tested in this trial

  • Osimertinib (Tagrisso®)
  • WSD0922-FU

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators