Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC Brain Metastases
A Clinical Study of Sac-TMT for Injection Combined With Third-Generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) ± Radiotherapy in Subjects With EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer and Brain Metastasis Who Have Failed Prior EGFR-TKI Treatment
Sponsor: Zhejiang Cancer Hospital + Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
6-month PFS rate
Time frame: 6 months post treatment initiation date (maximum follow-up of 36 months)
Secondary Endpoints
Overall ORR and DCR
DOR
OS
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF), regardless of gender; * Histologically or cytologically confirmed non-squamous NSCLC, and metastatic (Stage IV); * Confirmed EGFR sensitizing mutation including exon 19 deletion (19-Del) or exon 21 point mutation (L858R); * Subject has previously received EGFR-TKI therapy for locally advanced or metastatic disease and has experienced radiological PD; * Subjects with new or previously diagnosed brain metastasis confirmed by contrast-enhanced cranial MRI; * ECOG performance status scale of 0 or 1; * Life expectancy ≥ 12 weeks; * Adequate organ and bone marrow function; Exclusion Criteria: * Tumor histology or cytology confirms combined small cell lung cancer (SCLC), neuroendocrine carcinoma, carcinosarcoma components, or squamous cell carcinoma; * Known leptomeningeal metastases; * Other malignant tumors within 3 years prior to the first dose (except for tumors cured by local treatmen…
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