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NCT07197008PHASE2NOT_YET_RECRUITING

Sacituzumab Tirumotecan (Sac-TMT) Plus Bevacizumab in 3rd Generation EGFR-TKI Treated Advanced EGFR-mutant Nonsquamous NSCLC With Brain Metastasis

Sacituzumab Tirumotecan (Sac-TMT) Plus Bevacizumab in 3rd Generation EGFR-TKI Treated Advanced EGFR-mutant Nonsquamous NSCLC With Brain Metastasis: a Single-arm, Phase II Study(TOP BRAIN)

Sponsor: Li-kun Chen

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Key Facts

Study type
INTERVENTIONAL
Conditions
Lung Cancer
Interventions
Sacituzumab tirumotecan (Sac-TMT) plus bevacizumab
Enrollment
50 participants
Primary completion
Dec 2027
Study completion
Dec 2028
First posted
Sep 2025
Last updated
Sep 2025

Primary Endpoints (CT.gov)

intracranial objective response rate

Time frame: 6-months

Secondary Endpoints

intracranial progression-free survival

systemic objective response rate

progression-free survival

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 and ≤80 when signing the informed consent form, regardless of gender; 2. Histologically or cytologically confirmed nonsquamous NSCLC with EGFR-sensitive mutation (exon 19 deletion or exon 21 L858R mutation). 3. 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). 4. 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. 5. According to mRECIST 1.1, the subject must have at least one accurately measurable intracranial target lesion that has not been previously treated with local therapies such as radiation therapy or surgery. Brain metastatic lesions wit

Read full criteria on CT.gov →

✦ Analyst Commentary

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Source

Open on ClinicalTrials.gov