advanced NSCLC who have EGFR mutations combined with HER2 gene variations or protein expression
Conditions
Interventions
EGFR-TKI combined with trastuzumab rezetecan:EGFR-TKI combined with trastuzumab rezetecan
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old, gender not restricted; 2. ECOG score: 0 - 1; 3. Expected survival period: >= 3 months; 4. Histologically or cytologically confirmed locally advanced, inoperable or metastatic NSCLC; 5. According to the RECIST 1.1 standard, there must be at least one measurable lesion; 6. Before enrollment, no systemic anti-tumor treatment has been received (oral EGFR-TKI treatment within 2 weeks before enrollment is allowed); 7. Genetic testing clearly indicates EGFR mutations (including 19 deletion or L858R mutation); 8. HER2 variations exist, including any of the following types: (1) Genetically tested HER2 mutations or amplifications; (2) Immunohistochemistry shows low expression or overexpression of HER2 (HER2 1+/2+/3+); 9. Main laboratory tests are normal; 10. For pregnant women of childbearing age, a serum pregnancy test must be conducted 3 days before starting the study medication, and the result must be negative. They are willing to use an approved medical method of effective contraception (such as intrauterine device, contraceptive pills, or condoms) during the study period and within 180 days after the last administration of the study medication; for male participants whose partners are of childbearing age, surgical sterilization should be performed, or they should agree to use an effective method of contraception during the study period and within 180 days after the last administration of the study medication; 11. Participants voluntarily join this study and sign the informed consent form. They have good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Histological examination confirmed the presence of small cell lung cancer components; 2. During the screening period and before the radiological imaging assessment, symptomatic or actively progressing central nervous system (CNS) metastases or meningeal metastases were confirmed through CT or MRI. However, patients with stable CNS lesions and no symptoms, who have undergone local treatment, can also be enrolled as long as all of the following conditions are met: (1) The number of brain metastases is less than 5; (2) Measurable lesions determined according to RECIST v1.1 must be outside the CNS; (3) The patient has no history of intracranial hemorrhage or spinal cord hemorrhage; (4) Within 28 days before starting the study treatment, no neurosurgical resection has been performed, no whole brain radiotherapy has been performed within 14 days, or no stereotactic radiotherapy has been performed within 7 days; (5) The imaging confirmed that the lesion has been stable for at least 4 weeks, and systemic hormone therapy (dose = 2 weeks of intravenous antibiotic treatment, bacteremia, severe pneumonia, etc.) or any active infection within 4 weeks before the first administration; 10. Subjects with active pulmonary tuberculosis infection within 1 year before the first administration; 11. Subjects with any active, known or suspected autoimmune disease or autoimmune disease history, allowed to be enrolled in a stable state and not requiring systemic immunosuppressive therapy; 12. HBsAg positive and HBV DNA test value exceeds the upper limit of normal (1000 copy number/mL or 500 IU/mL), HCV positive (HCV RNA or HCV Ab test indicates acute or chronic infection), or active hepatitis B or hepatitis C patients, with known HIV positive h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);12-month PFS rate;adverse event; | — |
Countries
China
Contacts
Public ContactYongsheng Wang
West China Hospital of Sichuan University
Outcome results
None listed