Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC… (NCT07343479) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC Brain Metastases
China45 participantsStarted 2026-05-01
Plain-language summary
This is a prospective, open-label, multi-center, single-arm clinical trial
Who can participate
Age range18 Years – 75 Years
SexALL
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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 treatment, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, etc.);
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>470 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention;
* Unc…
What they're measuring
1
6-month PFS rate
Timeframe: 6 months post treatment initiation date (maximum follow-up of 36 months)