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.
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+/C797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and efficacy of WSD0922-FU in patients with advanced NSCLC whose cancers have progressed with or without brain metastasis following a first-line Osimertinib treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Oral, 21 days in each cycle
Oral, 21 days in each cycle
FOMAT Oncology
Oxnard, California, United States
RECRUITINGORR
proportion of patients with a best overall response of complete response or partial response
Time frame: every 8 weeks, up to 1 year
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 8 weeks, up to 1 year
PFS
proportion of patients with the time from randomization until the date of objective disease progression or death
Time frame: every 8 weeks, up to 1 year
Disease Control Rate (DCR)
the percentage of patients who have a best overall response of CR or PR or SD
Time frame: every 8 weeks, up to 1 year
Overall Survival (OS)
the time from the date of randomization until death due to any cause
Time frame: 24 months
EORTC QLQ-C30 (HRQoL)
PROs will be assessed using the EORTC QLQ-C30,changes in score compared to baseline will be evaluated.
Time frame: up to 24 months
EORTC QLQ-LC13 (HRQoL)
PROs will be assessed using the EORTC QLQ-LC13, changes in score compared to baseline will be evaluated.
Time frame: up to 24 months
PRO CTCAE (HRQoL)
To be assessed using the PRO CTCAE ,changes in symptoms compared to baseline will be evaluated.
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RECRUITING...and 8 more locations
Time frame: up to 24 months