A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer

A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation

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.

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.