Clinical trial · Observational
A Retrospective Study of the Efficacy and Safety of Lolatinib in ALK+ NSCLC Patients With Brain or Meningeal Metastasis
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK-positive Non-small Cell Lung Cancer | ALK-Positive Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Brain Metastases | — | UNRESOLVED | — |
| Meningeal Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lorlatinib | Drug | Lorlatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Advanced ALK+ NSCLC Patients with Brain or Meningeal Metastasis
- interventionNames
- Drug: Lorlatinib
Primary outcomes (1)
- 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.
- description
- 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 outcomes (3)
- measure
- PFS
- timeFrame
- From date of receiving therapy until date of disease progression or death, whichever came first, up to approximately 24 months.
- description
- Intracranial and systemic PFS as assessed by the investigators using RECIST V1.1 or RANO-BM Separately.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available