EICHORCondition: Metastatic Lung Cancer · Metastatic Lung Cancer With ALK/ROS1 Fusion · Sponsor: Hospices Civils de Lyon
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Targeted cancer therapies have a higher therapeutic index than chemotherapy and are prescribed to tens of thousands of patients in France each year. These treatments modify often ubiquitous signaling pathways involved in neuronal synaptic plasticity, the cellular substrate of cognitive and psychiatric functions. Neurocognitive and psychiatric disorders associated with targeted therapies are poorly described and therefore still poorly understood, although they appear to be clinically more severe than chemobrain (neurocognitive disorders related to chemotherapy). The case of patients with metastatic lung cancer with ALK/ROS1 fusion is emblematic. These cancers are treated very effectively with oral targeted therapies inhibiting the tyrosine kinase activity of ALK or ROS1 proteins (ITK-ALK/ROS1), with survival that can exceed 10 years. However, neurocognitive and psychiatric disorders associated with anti-ITK-ALK/ROS1 are reported in 7 to 60% of patients, with a prevalence of about 10% with anti-ITK-ALK/ROS1 brigatinib or alectinib and up to 53% with lorlatinib in industrial therapeutic trials. These disorders appear to be particularly frequent and severe with lorlatinib, including cognitive disorders - especially memory - mood disorders such as anxiety, depression and emotional lability, and psychotic disorders. Current therapeutic trials and care pathways are not designed to take into account these side effects related to anti-ITK-ALK/ROS1. Their incidence is therefore probab…
This description comes directly from the study's public registry record.
Michael DURUISSEAUX, Professor · +33 4 72 35 76 44 · michael.duruisseaux@chu-lyon.fr
Virginie DESESTRET, Professor · virginie.desestret@chu-lyon.fr
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Inclusion Criteria: * Adult patients aged 18 years or older, fluent in French * Currently treated with anti-ITK-ALK/ROS1 for ALK/ROS1-positive lung cancer * Identified by the prescribing physician as having complaints with or without associated neurocognitive and/or neuropsychiatric disorders related to the treatment. Exclusion Criteria: * History of neurocognitive and/or neuropsychiatric disorders prior to initiation of anti-ITK-ALK/ROS1 targeted therapy, excluding disorders associated with anti-ITK-ALK/ROS1 or other systemic anticancer treatments * Patients with uncontrolled brain metastases or carcinomatous meningitis (requiring symptomatic treatment with corticosteroids progressive or symptomatic) * Patients who do not have sufficient proficiency in French to complete questionnaires and/or participate in semi-structured interviews * Severe, progressive or unstable medical conditions that may interfere with the evaluation variables (uncontrolled epilepsy, acute psychiatric or psychotic disorders, visual hallucinations, acute infection). * Consumption of toxic substances that may affect cognitive performance * Deafness or blindness that may compromise participant evaluation or participation in tasks and scales * Patients who refuse to participate in the study or are unable to express thein non-opposition to participating in the study
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Day care Hospital, Pierre Wertheimer Hospital, Civil Hospitals of Lyon | Bron, France | Recruiting |
| Pneumology service, Louis Pradel Hospital, Civil Hospitals of Lyon | Bron, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06781905