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A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer
Trial Status: active
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.
Inclusion Criteria
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.
Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.
Documented EGFR mutation .
Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks.
At least one lesion, not previously irradiated and not chosen for biopsy during the study.
Females should have evidence of non-childbearing potential.
Exclusion Criteria
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.
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
Past medical history of ILD.
Inadequate bone marrow reserve or organ function as demonstrated.
Males and females of reproductive potential.
Known intracranial hemorrhage which is unrelated to tumor.
Seizures requiring a change in anti-epileptic medications.
Additional locations may be listed on ClinicalTrials.gov for NCT06868485.
Locations matching your search criteria
United States
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Approved
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
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.
