Lorlatinib in ROS1+ NSCLC With Brain Metastasis (NCT07083687) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Lorlatinib in ROS1+ NSCLC With Brain Metastasis
21 participantsStarted 2025-08-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Imaging (MR/CT) confirmed untreated brain metastases before lorlatinib initiation;
. Participants with asymptomatic brain metastases or currently unrequiring corticosteroid treatment, or on a stable or decreasing dose of ≤10 mg QD prednisone or equivalent can be enrolled.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intracranial Objective Response Rate (iORR), based on the modified version 1.1 of the Response Evaluation Criteria in Solid Tumors (RECIST)
. According to RECIST 1.1, patients must have at least one at least one measurable intracranial target lesion with the long axis greater or equal to 5 mm at baseline.
. Eastern Cooperative Oncology Group Performance (ECOG) score of 0-1.
Exclusion criteria
. 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.).
. Presence of spinal cord compression unless pain symptoms and neurological function have remained stable or improved 2 weeks prior to enrollment.
. Received open surgery (except surgery for biopsy purposes) within ≤14 days prior to enrollment.
. Received intracranial radiotherapy before enrollment.
. Fever with a temperature above 38℃ within the past week; or clinically significant bacterial, fungal, or viral infection, including but not limited to HIV infection, active HCV infection, active tuberculosis, active hepatitis B (active hepatitis B is defined as HBsAg positive and HBV-DNA copy number exceeds the upper limit of normal in the laboratory of the study center); or infections requiring hospitalization, septicemia, severe pneumonia, etc.