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.
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.
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.
Parallel
WSD0922-FU Tablets, Dose level A
DrugOral, 21 days in each cycle
WSD0922-FU Tablets, Dose level B
DrugOral, 21 days in each cycle
ORR
proportion of patients with a best overall response of complete response or partial response
Duration of Response (DoR)
proportion of patients with the time from the date of first documented response until the date of documented progression or death in the absence of disease progression
PFS
proportion of patients with the time from randomization until the date of objective disease progression or death
Disease Control Rate (DCR)
the percentage of patients who have a best overall response of CR or PR or SD
Overall Survival (OS)
the time from the date of randomization until death due to any cause
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