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
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ and dual EGFRm+/C797S+ receptor forms of EGFR with selectivity margin over wild-type EGFR. This study aims to explore the safety, tolerability, pharmacokinetic characteristics and efficacy of WSD0922-FU combined with Osimertinib in patients with non-small cell lung cancer (NSCLC) with C797S mutation after first-line third-generation EGFR-TKI resistance, and then further confirm the safety and efficacy for newly diagnosed NSCLC BM patients with classical EGFR Del19 or L858R mutation
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Drug: Osimertinib Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI Drug: Osimertinib Given PO, 80mg, once daily
Drug: WSD0922-FU Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI Drug: WSD0922-FU Given PO
Shanghai East Hospital
Shanghai, China
RECRUITINGPartA: To evaluate the safety of WSD0922-FU combined with Osimertinib in patients with NSCLC
Safety (incidence and severity of adverse events \[AE\])
Time frame: 12 months
PartB: To evaluate the efficacy of WSD0922-FU combined with Osimertinib in patients with NSCLC
ORR
Time frame: every 6 weeks, up to 2 years
To evaluate the safety of WSD0922-FU in patients with advanced non-small cell lung cancer
Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs)
Time frame: 12 months
Disease Control Rate (DCR)
the percentage of patients who have a best overall response of CR or PR or SD
Time frame: every 6 weeks, up to 24 months
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
Time frame: every 6 weeks, up to 24 months
PFS
proportion of patients with the time from randomization until the date of objective disease progression or death
Time frame: every 6 weeks, up to 24 months
Intracranial Disease Control Rate (iDCR)
the percentage of patients who have a best overall response of CR or PR or SD per RANO BM
Time frame: every 6 weeks, up to24 months
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Intracranial Duration of Response (iDoR)
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 per RANO BM
Time frame: every 6 weeks, up to 24 months
iPFS
proportion of patients with the time from randomization until the date of objective disease progression or death per RANO BM
Time frame: every 6 weeks, up to 24 months