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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWayshine Biopharm, Inc.

About this trial

This study is a multicenter, open label, single-arm phase I/II clinical trial of WSD0922-FU for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with thrid-generation EGFR-TKI .

Eligibility criteria

Qualifiers

Age 18-75 years old (including the threshold value), gender is not limited;

Locally advanced or metastatic NSCLC confirmed by pathology;

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

Blood samples must be provided for testing and must be taken during or after disease progression following the last EGFR TKI inhibitor treatment;

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 one EGFR-TKI inhibitor;

Received other unlisted clinical study drugs or treatments within 4 weeks before the first administration.

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.

Trial design

Treatments tested in this trial

  • WSD0922-FU

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators