NCT06631989 A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer
| NCT ID | NCT06631989 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Wayshine Biopharm, Inc. |
| Condition | EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-04 |
| Primary Completion | 2027-06-30 |
Trial Parameters
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Brief Summary
This study is a multicenter, open label, single-arm phase I/II clinical trial of WSD0922-FU for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with thrid-generation EGFR-TKI .
Eligibility Criteria
Inclusion Criteria: * Age 18-75 years old (including the threshold value), gender is not limited; * Locally advanced or metastatic NSCLC confirmed by pathology; * Patients who have been genetically tested to carry EGFR sensitive mutations; * Blood samples must be provided for testing and must be taken during or after disease progression following the last EGFR TKI inhibitor treatment; * Must have a minimum life expectancy of \>= 3 months; * At least one measurable tumor lesion according to RECIST version 1.1; Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions. * Physical Status (ECOG PS) score was 0-1; * Have full organ function; * Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ; * Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily. Exclusion Criteria: * Received chemothera
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