A Retrospective Study of the Efficacy and Safety of Lolatinib in ALK+ NSCLC Patients With Brain or Meningeal Metastasis

Brain Metastases Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06410040
• Other study ID #: EK2023003
• Status: Active, not recruiting
• Start date: August 20, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ALK-positive Non-small Cell Lung Cancer
• Brain Metastases
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Meningeal Carcinomatosis
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Drug:
• Lorlatinib
lolatinib 100mg qd po

Locations

Country	Name	City	State
China	Sichuan cancer hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of receiving therapy until date of disease progression or the end of study, whichever came first, assessed up to 24 months.
Secondary	PFS	Intracranial and systemic PFS as assessed by the investigators using RECIST V1.1 or RANO-BM Separately.	From date of receiving therapy until date of disease progression or death, whichever came first, up to approximately 24 months.
Secondary	OS	Overall survival for first-line and late-line of lorlatinib medication	From date of receiving therapy until date of disease progression or death, whichever came first, assessed up to approximately 24 months.
Secondary	AE	Number and percentage of participants with treatment-related AEs as assessed by CTCAE v5.0, and the duration of AEs on every grade	From date of receiving therapy until date of disease progression or death or the end of study, assessed up to approximately 24 months.