Lorlatinib in ROS1+ NSCLC With Brain Metastasis
ConditionLung Cancer (NSCLC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Cancer Hospital
About this trial
The goal of this Phase II, multicenter, open-label, single-arm clinical trial is to evaluate the intracranial efficacy and safety of lorlatinib in adults with TKI-naïve, advanced ROS1-positive non-small cell lung cancer (NSCLC) and untreated brain metastases. The main questions it aims to answer are:
What is the intracranial efficacy (eg., objective response rate/PFS) assessed by revised RECIST v1.1?
How do exploratory biomarkers (e.g., ctDNA dynamics in plasma/CSF) correlate with lorlatinib resistance?
Participants will:
Receive lorlatinib 100 mg orally once daily until disease progression or unacceptable toxicity.
Undergo brain MRI/CT scans every 8 weeks (first 12 cycles) and every 16 weeks thereafter.
Provide blood samples for safety/biomarker analysis and optional CSF samples via lumbar puncture during scheduled visits.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years old.
Histologically or cytologically confirmed diagnosis of ROS1+ NSCLC with brain metastases before the use of lorlatinib.
ROS1 rearrangement positive confirmed by IHC FISH, PCR, or next generation sequencing (NGS). Patients with other treatable gene mutations besides ROS1 need to submit for discussion with the study experts to determine eligibility.
Treatment naïve or one prior systemic treatment with platinum-based chemotherapy.
Disqualifiers
Have received treatment with the investigational drug or known allergy to the ingredients or excipients of the investigational drug.
Concurrent participation in another clinical study, except for observational (non-interventional) clinical studies or subsequent stages of interventional studies.
Brain metastasis combined with leptomeningeal metastases.
Brain metastasis with bleeding, or the presence of central nervous system complications requiring urgent local intervention (such as surgery, radiotherapy, etc.).
Trial design
Design model
Single group
Treatments tested in this trial
Lorlatinib 100 mg
DrugAfter enrollment, patients will receive 100 mg of lorlatinib orally once daily until disease progression, unacceptable toxicity, or withdraw study .
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: 100mg lorlatinib QD OrallyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Intracranial Objective Response Rate (iORR), based on the modified version 1.1 of the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame
up to 26 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: