Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC Brain Metastases
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital
About this trial
This is a prospective, open-label, multi-center, single-arm clinical trial
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- sac-TMT plus EGFR-TKI
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Zhejiang Cancer Hospital
Lead sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov