ALK-positive Non-small Cell Lung CancerNCT06410040
A Retrospective Study of the Efficacy and Safety of Lolatinib in ALK+ NSCLC Patients With Brain or Meningeal Metastasis
An observational study of ALK-positive Non-small Cell Lung Cancer and Brain Metastases, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
This study was a retrospective observational study. The study included patients with non-small cell lung cancer with ALK-fusion brain metastases or meningeal metastases who received first-line and late-line treatment with the third-generation ALK TKI lorlatinib between June 2022 and June 2023. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALK-positive Non-small Cell Lung Cancer, Brain Metastases, Meningeal Metastasis
- What is being tested?
- Lorlatinib
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All ALK-mutated non-small cell lung cancer patients with brain or meningeal metastasis were included.
Who may be able to join
- Age ≥18 years
- Diagnosis of advanced NSCLC with clear pathology and brain metastases confirmed by MRI or CT scan of the brain or meningeal metastases confirmed by imaging or lumbar puncture cerebrospinal fluid cytology
- ALK fusion mutation confirmed by tumor histology or hematology
- Treatment with lorlatinib from June 2022 to June 2023
- Survival greater than 12 weeks
Who cannot join
- Patients treated with lorlatinib for less than 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study of the Efficacy and Safety of Lolatinib in Anaplastic Lymphoma Kinase (ALK) - Positive Non-Small Cell Lung Cancer (NSCLC) Patients With Brain or Meningeal Metastasis
This study was a retrospective observational study. The study included patients with non-small cell lung cancer with ALK-fusion brain metastases or meningeal metastases who received first-line and late-line treatment with the third-generation ALK TKI lorlatinib between June 2022 and June 2023.
Data were collected from the electronic medical records database and hospital information system of many hospitals in Sichuan Province. Clinical pathology features including gender, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from the medical records. The physical condition assessed by ECOG-PS before the administration of lorlatinib was recorded. Information on anti-tumor therapy was obtained from the records, including dose and time of ALK-TKI therapy and tumor response, number of prior systemic therapy lines, drug regimen, efficacy, and whether local therapy such as radiotherapy and surgery had been received. In this study, the sample size is not limited, and information is collected according to the maximum number of patients. The study period was from 01 July 2023 to 30 June 2024.
- Being tested
- Lorlatinib
- Medical subject headings
- Brain Neoplasms, Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorlatinibDrug
lolatinib 100mg qd po
| Study group | Role | What they receive |
|---|---|---|
| Advanced ALK+ NSCLC Patients with Brain or Meningeal Metastasis | Not described Receives: Drug: Lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
the Sum of percentage of participants with CR and PR as assessed by RECIST v1.1 or RANO-BM criteria every 8-12 weeks.
Measured: From date of receiving therapy until date of disease progression or the end of study, whichever came first, assessed up to 24 months.
Secondary outcomes (3)
PFS
Intracranial and systemic PFS as assessed by the investigators using RECIST V1.1 or RANO-BM Separately.
Measured: From date of receiving therapy until date of disease progression or death, whichever came first, up to approximately 24 months.
OS
Overall survival for first-line and late-line of lorlatinib medication
Measured: From date of receiving therapy until date of disease progression or death, whichever came first, assessed up to approximately 24 months.
AE
Number and percentage of participants with treatment-related AEs as assessed by CTCAE v5.0, and the duration of AEs on every grade
Measured: From date of receiving therapy until date of disease progression or death or the end of study, assessed up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start20 Aug 2023
- Primary completion31 Mar 2024
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK-positive Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan LI, MD, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410040
- Sponsor's protocol ID
- EK2023003
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of the Efficacy and Safety of Lolatinib in Anaplastic Lymphoma Kinase (ALK) - Positive Non-Small Cell Lung Cancer (NSCLC) Patients With Brain or Meningeal Metastasis
- ClinicalTrials.gov ID
- NCT06410040
- Acronym / sponsor ID
- EK2023003
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a retrospective observational study. The study included patients with non-small cell lung cancer with ALK-fusion brain metastases or meningeal metastases who received first-line and late-line treatment with the third-generation ALK TKI lorlatinib between June 2022 and June 2023.
Data were collected from the electronic medical records database and hospital information system of many hospitals in Sichuan Province. Clinical pathology features including gender, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from the medical records. The physical condition assessed by ECOG-PS before the administration of lorlatinib was recorded. Information on anti-tumor therapy was obtained from the records, including dose and time of ALK-TKI therapy and tumor response, number of prior systemic therapy lines, drug regimen, efficacy, and whether local therapy such as radiotherapy and surgery had been received. In this study, the sample size is not limited, and information is collected according to the maximum number of patients. The study period was from 01 July 2023 to 30 June 2024.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced ALK+ NSCLC Patients with Brain or Meningeal Metastasis | – | Drug: Lorlatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All ALK-mutated non-small cell lung cancer patients with brain or meningeal metastasis were included.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Diagnosis of advanced NSCLC with clear pathology and brain metastases confirmed by MRI or CT scan of the brain or meningeal metastases confirmed by imaging or lumbar puncture cerebrospinal fluid cytology
- ALK fusion mutation confirmed by tumor histology or hematology
- Treatment with lorlatinib from June 2022 to June 2023
- Survival greater than 12 weeks
Key exclusion criteria (1 listed)
- Patients treated with lorlatinib for less than 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lorlatiniblolatinib 100mg qd po | Drug | Advanced ALK+ NSCLC Patients with Brain or Meningeal Metastasis |
Primary outcome
ORR
Time frame: From date of receiving therapy until date of disease progression or the end of study, whichever came first, assessed up to 24 months.
the Sum of percentage of participants with CR and PR as assessed by RECIST v1.1 or RANO-BM criteria every 8-12 weeks.
3 secondary outcomes
PFS
Time frame: From date of receiving therapy until date of disease progression or death, whichever came first, up to approximately 24 months.
OS
Time frame: From date of receiving therapy until date of disease progression or death, whichever came first, assessed up to approximately 24 months.
AE
Time frame: From date of receiving therapy until date of disease progression or death or the end of study, assessed up to approximately 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALK-positive Non-small Cell Lung Cancer and Brain Metastases, run by Sichuan Cancer Hospital and Research Institute at 1 site 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
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?
ORR (time frame: From date of receiving therapy until date of disease progression or the end of study, whichever came first, assessed up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2024.