This is a prospective, single-center, phase 2 clinical study to explore the efficacy and safety of Sac-TMT in combination with bevacizumab for patients with EGFR-mutated nonsquamous NSCLC with brain metastases. The study will enroll 50 EGFR-sensitive mutation(19del/21L858R) nonsquamous NSCLC patients who progressed on or after 3rd generation EGFR-TKI with brain metastases.
Age ≥ 18 and ≤80 when signing the informed consent form, regardless of gender;
Histologically or cytologically confirmed nonsquamous NSCLC with EGFR-sensitive mutation (exon 19 deletion or exon 21 L858R mutation).
Progression on or after 3rd-generation EGFR-TKI (change to the third-generation EGFR-TKIs after receiving 1st or 2nd generations of TKI, or to use the third-generation TKI in the first line are all allowed).
Brain parenchymal metastases confirmed by cranial MRI, including asymptomatic BM or those with symptoms controlled after local treatment and/or dehydration therapy, should maintain a clinically stable state (no longer requiring glucocorticoids or anticonvulsants) for at least 2 weeks before the first dose.
Histologically or cytologically confirmed tumor with components of small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or squamous cell carcinoma;
Patients with spinal cord compression or those assessed by the investigator as having extensive meningeal metastasis;
Previous whole-brain radiotherapy for brain metastases;
Subjects who have previously received chemotherapy, TROP2-targeted therapy, or any drug therapy containing topoisomerase I inhibitors, including antibody-drug conjugate (ADC) therapy (including in the context of adjuvant or neoadjuvant therapy);
Single group
Sacituzumab tirumotecan (Sac-TMT) plus bevacizumab
DrugEligible patients will receive Sacituzumab tirumotecan at a dose of 4 mg/kg in combination with bevacizumab 5mg/kg by intravenous infusion on day 1 and day 15 of each 28-day cycle.
intracranial objective response rate
proportion of patients with complete or partial response of intracranial lesions
intracranial progression-free survival
time from enrollment to intracranial disease progression or death.
systemic objective response rate
proportion of patients with complete or partial response of overall lesions
progression-free survival
time from enrollment to systemic disease progression \[intracranial or extracranial or both\] or death
overall survival
time from enrollment to death from any cause
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Li-kun Chen
Lead sponsor
Sun Yat-sen University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
