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
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