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

Inclusion criteria:

• Provision of signed and dated, written informed consent prior to any study-specificprocedures, 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 orradiotherapy.

• Evidence of radiological disease progression while on a previous continuoustreatment with first-line Osimertinib treatment.

• Documented EGFR mutation .

• Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12weeks.

• At least one lesion, not previously irradiated and not chosen for biopsy during thestudy.

• Females should have evidence of non-childbearing potential.

Exclusion criteria:

• Any investigational agents or other anticancer drugs from a previous treatmentregimen 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 medicalintervention.

• Any evidence of severe or uncontrolled systemic diseases.

• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability toswallow 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.