Clinical trial NCT06410040: A Retrospective Study of the Efficacy and Safety of Lolatinib in ALK+ NSCLC Patients With Brain or Meningeal Metastasis
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: ALK-positive Non-small Cell Lung Cancer
Brain Metastases
Meningeal Metastasis
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All ALK-mutated non-small cell lung cancer patients with brain or meningeal metastasis were included.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. 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
3. ALK fusion mutation confirmed by tumor histology or hematology
4. Treatment with lorlatinib from June 2022 to June 2023
5. Survival greater than 12 weeks

Exclusion Criteria:

Patients treated with lorlatinib for less than 4 weeks

Primary outcomes:
measure: ORR
timeFrame: 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:
measure: PFS
timeFrame: From date of receiving therapy until date of disease progression or death, whichever came first, up to approximately 24 months.
measure: OS
timeFrame: From date of receiving therapy until date of disease progression or death, whichever came first, assessed up to approximately 24 months.
measure: AE
timeFrame: From date of receiving therapy until date of disease progression or death or the end of study, assessed up to approximately 24 months.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan cancer hospital
state: Sichuan
Study officials:
References: