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

Active, not recruiting

• Conditions: ALK-positive Non-small Cell Lung Cancer; Meningeal Metastasis; Brain Metastases
• Interventions: Drug: Lorlatinib

• Registration Number: NCT06410040
• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-20
• Primary Completion: 2024-03-31
• Status Verified: 2024-05
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-08
• Study First Posted: 2024-05-10
• Last Update Posted: 2024-05-10
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced ALK+ NSCLC Patients with Brain or Meningeal Metastasis	Lorlatinib	-

Primary Outcome Measures

Name	Time	Method
ORR	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sichuan cancer hospital; 🇨🇳 Chengdu, Sichuan, China