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

NCT ID: NCT06410040

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-20
• Study Completion Date: 2024-06-30

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.

Conditions

ALK-positive Non-small Cell Lung Cancer; Brain Metastases; Meningeal Metastasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Advanced ALK+ NSCLC Patients with Brain or Meningeal Metastasis

Lorlatinib

Intervention Type: DRUG

lolatinib 100mg qd po

Interventions

Lorlatinib

lolatinib 100mg qd po

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Juan LI, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sichuan cancer hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

EK2023003

Identifier Type: -

Identifier Source: org_study_id