Clinical trial · Observational
The Incidence and Risk Factors of Central Nervous System Adverse Events of Lorlatinib in Patients with ALK-positive Advanced Non-small Cell Lung Cancer: a Real-world Study
The CNS AE of Lorlatinib in Patients with ALK-positive Advanced NSCLC
NCT06652555CI-TRIAL-00081811not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.
Conditions
Conditions (2)
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 | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group 1 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- group 1
- description
- Baseline characteristics and information during loratinib treatment were collected
- interventionNames
- Other: Group 1
Primary outcomes (1)
- measure
- Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study.
- timeFrame
- 2 year
- description
- The incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib will be reported, such as cognitive effects, mood effects, speech effects and psychotic effects.
Secondary outcomes (3)
- measure
- To explore the optimized therapy management strategies for CNS AEs associated with lorlatinib in real-world study.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer; * ALK-positive and the test results were based on RT-PCR /FISH /IHC /NGS methods in the laboratory department or testing institution of the hospital * receiving targeted therapy with Lorlatinib * age ≥18 years old * follow-up after receipt of Lorlatinib * voluntarily participate in the study and sign informed consent Exclusion Criteria: * evidence of any severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, active infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). * combined with other malignant tumors and received other anti-tumor therapy during the treatment of Lorlatinib
References
Publications (0)
Data not yet available
No reference posted for this study.