Single Arm Study of WSD0922-FU for NSCLC Patients with C797S mutation

Prior treatment

• 1 Treatment with more than 2 prior lines of treatment for advanced NSCLC.Treatment with Osimertinib within 8 days of the first dose of study treatment.
• Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.
• Leptomeningeal metastasis.
  • 5.Any evidence of severe or uncontrolled systemic diseases.
  • 6.Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.

Other illness

• History of hypersensitivity of WSD0922-FU.
• Known intracranial hemorrhage which is unrelated to tumor.
• Seizures requiring a change.
• Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
  • 9.Inadequate bone marrow reserve or organ function as demonstrated.

Lab values

• Any of the following cardiac criteria: Mean resting corrected QT interval (QTc) > 480 msec, obtained from electrocardiograms (ECGs); Any clinically important abnormalities in rhythm; Any factors that increase the risk of QTc prolongation.

Other

• Males and females of reproductive potential who are not using an effective method of birth control.
• Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
• Patient must not take enzyme-inducing anticonvulsants treatment.
• Symptomatic brain complications that require urgent neurosurgical or medical intervention.

• Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
• Females should be using adequate contraceptive measures.
• Male patients should be willing to use barrier contraception i.e., condoms.
• Patient must be stable on no more than 2 mg of dexamethasone.
• 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.
• Documented EGFR mutation
• Patients must have confirmation of C797S mutation positive status.
  • 8.Eastern Cooperative Oncology Group (ECOG) 0-1.
• At least one lesion, not previously irradiated and not chosen for biopsy during the study.