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Neurocognitieve effecten van lorlatinib: hoe de zorg te verbeteren

Lorlatinib neurocognitive adverse events: how to improve patient care

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27508
Enrollment
20
Registered
2018-10-17
Start date
2018-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

NSCLC

Interventions

Neurocognitive adverse events will be evaluated by standardized neurocognitive tests that cover the most important domains of neurocognition. All the tests will be performed at baseline (i.e. maximum

Sponsors

academisch ziekenhuis maastricht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Stage IV NSCLC with ALK or ROS1 rearrangement, indication in daily clinical care to start lorlatinib treatment - Age ≥ 18 years - Ability to understand neurocognitive testing - Written informed consent

Exclusion criteria

Exclusion criteria: - Neurodegenerative diseases (such as Alzheimers disease) - Psychiatric disease - Symptomatic brain metastases / neurological symptoms due to previous cranial irradiation (e.g. due to radiation necrosis) - Inability to understand the testing / questionnaires

Design outcomes

Primary

MeasureTime frame
-change for every neurocognitive endpoint during treatment with lorlatinib compared to baseline

Secondary

MeasureTime frame
- Correlation of neurocognitive impairment on the neurocognitive tests to the self-reported neurocognitive impairment - Correlation of neurocognitive impairment on the neurocognitive tests to the CTCAE scored neurocognitive impairment

Contacts

Public ContactL. Hendriks

Dept of Pulmonary Diseases, MUMC+ PO Box 5800

lizza.hendriks@mumc.nl+31 (0) 43 387 6543

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)