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Carcinoma, Non-Small-Cell LungPhase 4NCT06282874

Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases

A Phase 4 study testing Lorlatinib in people with Carcinoma, Non-Small-Cell Lung and Brain Metastases, run by Guangdong Association of Clinical Trials at 3 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is an investigator-initiated, prospective, open-label, single-arm, multicenter clinical trial aimed at exploring the antitumor activity of Lorlatinib in ALK-positive NSCLC patients with brain/ leptomeningeal metastases. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lorlatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
3 sitesChina
Study dates
1 Aug 2024to 1 Mar 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years, regardless of sex.
  • Histologically or cytologically confirmed ALK-positive NSCLC.
  • ALK rearrangement positive confirmed by FISH, RT-PCR, IHC Ventana D5F3, or NGS. Patients with other actionable genomic alterations in addition to ALK must be reviewed by the study expert panel to determine eligibility.
  • Patients who have not received prior systemic treatment for advanced NSCLC, or who have experienced disease progression on or intolerance to at least one prior systemic treatment regimen, including an ALK inhibitor, are eligible for enrollment. If the treatment immediately prior to study drug administration was an ALK inhibitor, the washout period may be determined after discussion by the study expert panel.
  • Toxicities related to prior systemic treatment must have recovered to ≤ Grade 1 (CTCAE version 5.0) or to baseline levels, except for adverse events that, in the investigator's judgment, do not pose a safety risk to the subject.
  • At least one CNS lesion meeting one of the following criteria must be present: 1.leptomeningeal metastasis suggested by imaging and/or cerebrospinal fluid findings; cerebrospinal fluid confirmation is not required for imaging-suspected leptomeningeal metastasis; or 2.brain parenchymal metastasis confirmed by magnetic resonance imaging (MRI), with ≥3 brain lesions, or 1-2 lesions that are not suitable for surgery or for which the patient refuses surgery. In patients without leptomeningeal metastasis, at least one measurable brain lesion with a diameter of ≥5 mm is required.
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  • Patients with or without symptoms related to brain and/or leptomeningeal metastases are eligible.
  • Life expectancy must be at least 12 weeks.
  • ECOG performance status of 0-2 for patients without leptomeningeal metastasis, and 0-3 for patients with leptomeningeal metastasis.
  • The investigator considers the subject to have generally adequate major organ function, including hematologic, coagulation, hepatic, renal, and pancreatic function.
  • For women of childbearing potential (defined as women who are not postmenopausal for at least 1 year and have not undergone surgical sterilization or hysterectomy), a serum or urine pregnancy test must be performed within 7 days before the first administration of study drug, and the result must be negative. All subjects, male or female, must agree to use adequate contraception throughout the treatment period and for at least 90 days after the last dose of study drug.
  • Subjects must understand and voluntarily sign the written informed consent form, have good compliance, be willing to follow the study treatment plan and visit schedule, and be able to cooperate with safety and efficacy assessments.

Who cannot join

  • 1. Prior treatment with the investigational drug, or known hypersensitivity to the active substance or any excipients of the investigational drug.
  • 2. Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study. Subjects who have received any other investigational drug within 28 days before initiation of study treatment are excluded.
  • In the investigator's judgment, the subject requires urgent local intervention, such as surgery or radiotherapy.
  • Presence of spinal cord compression, unless pain symptoms and neurological function have remained stable or improved for at least 2 weeks prior to enrollment.
  • Open surgery within 14 days prior to enrollment, except for procedures performed for biopsy purposes.
  • Fever >38°C within 1 week prior to enrollment; or clinically significant bacterial, fungal, or viral infection, including but not limited to HIV infection, active HCV infection, or active pulmonary tuberculosis; or infectious complications requiring hospitalization, bacteremia, severe pneumonia, or other clinically significant infections.
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  • Clinically significant abnormalities in rhythm, conduction, or morphology on resting electrocardiogram (ECG), such as complete left bundle branch block, second-degree or higher atrioventricular block, clinically significant ventricular arrhythmia, or atrial fibrillation.
  • Current or recent (within 3 months prior to enrollment) unstable angina, congestive heart failure (New York Heart Association Class III or IV), myocardial infarction, coronary artery or peripheral artery bypass grafting, cerebrovascular accident, transient ischemic attack not adequately treated with anticoagulation, or symptomatic pulmonary embolism.
  • Current clinically active interstitial lung disease, or radiation pneumonitis requiring corticosteroid treatment on the day of enrollment.
  • Dysphagia, active gastrointestinal disease, or any other condition that may significantly affect the absorption, distribution, metabolism, or excretion of the investigational drug; or history of major gastric resection.
  • Other acquired or congenital immunodeficiency disorders, or prior solid organ or hematologic transplantation.
  • Evidence of severe or uncontrolled systemic disease, including but not limited to severe psychiatric or neurologic disorders, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic, or renal disease, or uncontrolled hypertension (defined as hypertension that remains at CTCAE version 5.0 Grade 3 or higher despite medical treatment).
  • Use or consumption within 2 weeks prior to enrollment of known strong CYP3A4 inhibitors; use within 2 weeks prior to enrollment of known strong CYP3A4 inducers; or use within 2 weeks prior to enrollment of CYP3A4 substrate drugs with a narrow therapeutic index.
  • Severe acute or chronic psychiatric illness, including recent (within the past year) or active suicidal ideation or behavior.
  • Pregnant or breastfeeding women, or male or female subjects of reproductive potential who refuse to use effective contraception during treatment and for 90 days after the last dose of study drug.
  • In the investigator's judgment, the subject may be unable to complete the study or comply with study requirements.
  • Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in the study.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Tenth Affiliated Hospital, Southern Medical University (Dongguan people's hospital)

    Dongguan, Guangdong, 510080

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 510080

  • Guangdong Provincial Perople's Hospital

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: An Open-label, Single-arm, Multicenter, Prospective Study of Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases

This study is an investigator-initiated, prospective, open-label, single-arm, multicenter clinical trial aimed at exploring the antitumor activity of Lorlatinib in ALK-positive NSCLC patients with brain/ leptomeningeal metastases.

Read the detailed description

Fifty eligible subjects will be divided into a BM cohort (brain parenchymal metastasis only) and an LM cohort (leptomeningeal metastasis ± brain parenchymal metastasis). All subjects will receive Lorlatinib 100 mg once daily on days 1 to 28 of each 28-day cycle.

Being tested
Lorlatinib
Keywords
ALK-Positive Non-Small-Cell Lung Cancer, Brain Metastases, Leptomeningeal Metastasis
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Meningeal Carcinomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LorlatinibDrug

    Also called PF-06463922

    Lorlatinib 100 mg once daily on days 1 to 28 of each 28-day cycle

Study groups in NCT06282874
Study groupRoleWhat they receive
BM/LM cohortExperimentalFifty eligible subjects will be divided into a BM cohort (brain parenchymal metastasis only) and an LM cohort (leptomeningeal metastasis ± brain parenchymal metastasis)
Receives: Drug: Lorlatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intracranial objective response rate（iORR）

    BM Cohort: percentage of participants demonstrating an intracranial complete response or partial response according to modified RECIST v1.1 criteria; LM Cohort: percentage of participants demonstrating an intracranial complete response or partial response according to the imaging criteria of RANO-LM.

    Measured: From date of the first dose of lorlatinib treatment until the date of last follow up or death, up to 18 months.

Secondary outcomes (5)

  1. Progression-free survival (PFS) and intracranial PFS（iPFS）

    PFS defined as time from the first dose of lorlatinib to the first documentation of progression or death from any cause. Specifically, intracranial PFS pertains to the progression of the disease confined within the brain.

    Measured: From date of the first dose of lorlatinib treatment until the date of last follow up or death, up to 18 months.

  2. Obiective response rate (ORR)

    ORR defined as assessed percentage of participants demonstrating a complete response or partial response including central nervous system disease, extracranial disease and overall disease.

    Measured: From date of the first dose of lorlatinib treatment until the date of last follow up or death, up to 18 months.

  3. Disease control rate (DCR) and intracranial disease control rate (iDCR)

    Disease Control Rate, is determined by assessing the percentage of participants who achieve a best response of confirmed Complete Response (CR), confirmed Partial Response (PR), or exhibit stable disease for various disease sites including central nervous system, extracranial, and leptomeningeal involvement, as well as overall disease status. Specifically, intracranial DCR focuses on evaluating the disease control rate within the brain.

    Measured: From date of the first dose of lorlatinib treatment until the date of last follow up or death, up to 18 months.

  4. Overall survival

    Overall survival defined as time from the start of treatment until death or last follow-up

    Measured: From date of the first dose of lorlatinib treatment until the date of last follow up or death, up to 18 months.

  5. Number of participants with adverse events

    Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.

    Measured: From date of the first dose of lorlatinib treatment until the date of last follow up or death, up to 18 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start1 Aug 2024
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282874
Sponsor's protocol ID
CTONG2303
Status last verified
Jan 2026
First submitted
30 Jan 2024
Last updated
9 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lorlatinib in people with Carcinoma, Non-Small-Cell Lung and Brain Metastases, run by Guangdong Association of Clinical Trials at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intracranial objective response rate（iORR） (time frame: From date of the first dose of lorlatinib treatment until the date of last follow up or death, up to 18 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06282874.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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