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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
sac-TMT plus EGFR-TKI
DrugEligible subjects will receive sac-TMT (4 mg/kg, twice weekly (Q2W)) + third-generation EGFR-TKI ± intracranial radiotherapy. The decision to initiate intracranial radiotherapy will be determined by the investigator based on the patient's clinical condition.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: sac-TMT plus EGFR-TKIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
6-month PFS rate
6-month PFS rate as assessed by the investigators according to RECIST v1.1.
Time frame
6 months post treatment initiation date (maximum follow-up of 36 months)Secondary outcomes
1
Overall ORR and DCR
Overall ORR and DCR as assessed by the investigators according to RECIST v1.1
Time frame
From initiation of treatment to disease progression or death from any cause, whichever occurs first (maximum follow-up of 36 months)2
DOR
DOR as assessed by the investigators according to RECIST v1.1
Time frame
From first disease response until tumor progression (maximum follow-up of 36 months).3
OS
Time from treatment initiation to date of death due to any cause or last day of contact.
Time frame
From treatment initiation to death due to any cause or last day of contact, whichever occurred first (maximum follow-up of 36 months)4
Safety endpoints
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) \[based on the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI)\]
Time frame
From first dose of study treatment until 30 days after the last dose, assessed up to 36 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhejiang Cancer Hospital
Lead sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov
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