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The incidence and related 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 incidence and related factors of central nervous system adverse events of Lorlatinib in patients with ALK fusion positive advanced non-small cell lung cancer: a real-world study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093310
Enrollment
Unknown
Registered
2024-12-02
Start date
2024-12-15
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Observation group:None

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed stage IIIb-IV NSCLC or postoperative recurrent NSCLC; 2.ALK positive, and the test results were based on RT-PCR /FISH /IHC /NGS methods in hospital laboratories or testing institutions; 3.Treated with Lorlatinib; 4.Age >=18; 5.Follow-up after receipt of Lorlatinib; 6.Voluntarily enrolled in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Any evidence of severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV); 2.The patient was complicated with other malignant tumors and received other anti-tumor therapy during the treatment of loratinib.

Design outcomes

Primary

MeasureTime frame
Effect of management measures for Ce-n-t-r-al Ne-r-v-o-us Sy-s-t-em adverse events occurring after loratinib treatment on AE;

Secondary

MeasureTime frame
Incidence of central nervous system (CNS) adverse events (AEs) associated with lorlatinib in real world study;

Countries

China

Contacts

Public ContactChunxia Su

Shanghai Pulmonary Hospital

susu_mail@126.com+86 13601899076

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026