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Lorlatinib in ROS1+ NSCLC With Brain Metastasis

NCT07083687 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-07-24

No results posted yet for this study

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.

Conditions

  • Lung Cancer (NSCLC)

Interventions

DRUG

Lorlatinib 100 mg

After enrollment, patients will receive 100 mg of lorlatinib orally once daily until disease progression, unacceptable toxicity, or withdraw study .

Sponsors & Collaborators

  • Hunan Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2027-01-01
Completion
2028-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07083687 on ClinicalTrials.gov