WSD0922-FU Tablets, Dose level AWSD0922-FU Tablets, Dose level B
WSD0922-FU Tablets, Dose level A: Oral, 21 days in each cycle
WSD0922-FU Tablets, Dose level B: Oral, 21 days in each cycle
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
ORR — every 8 weeks, up to 1 year proportion of patients with a best overall response of complete response or partial response
Trial sites (18)
Facility
City
Region
Status
FOMAT Oncology
Oxnard
California
Recruiting
Cleveland Clinic Weston Hospital
Weston
Florida
Recruiting
Karmanos Cancer Institute
Detroit
Michigan
Recruiting
Hackensack Meridian Health-Southern Ocean Medical Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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