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

NCT06410040 | Active Not Recruiting FDA Drug

• 1 other identifier: EK2023003
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• PFS

  From date of receiving therapy until date of disease progression or death, whichever came first, up to approximately 24 months.

• OS

  From date of receiving therapy until date of disease progression or death, whichever came first, assessed up to approximately 24 months.

• AE

  From date of receiving therapy until date of disease progression or death or the end of study, assessed up to approximately 24 months.

Study Arms (1)

Advanced ALK+ NSCLC Patients with Brain or Meningeal Metastasis

Drug: Lorlatinib

Interventions

Lorlatinib DRUG

lolatinib 100mg qd po

Advanced ALK+ NSCLC Patients with Brain or Meningeal Metastasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All ALK-mutated non-small cell lung cancer patients with brain or meningeal metastasis were included.

You may qualify if:

• 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

You may not qualify if:

• Patients treated with lorlatinib for less than 4 weeks

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan cancer hospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Brain Neoplasms; Meningeal Carcinomatosis

Interventions

lorlatinib

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Meningeal Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 10, 2024
• Study Start: August 20, 2023
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)