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Description of Neurocognitive and Psychiatric Disorders Associated With Targeted Therapies Used in the Treatment of Lung Cancers With ALK/ROS1 Fusion and Their Impact on Patients' Quality of Life: Construction of an Experimental Patient-researcher Collaborative Care and Research Pathway

NCT06781905 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-12-30

No results posted yet for this study

Summary

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 probably underestimated.

The DRACONIS project aims to:

(1) describe the complaints +/- neurocognitive and neuropsychiatric disorders associated with anti-ITK-ALK/ROS1 through a rigorous neuropsychological and psychiatric evaluation (i.e. patient phenotyping) and (2) understand the experience of complaints +/- neurocognitive and neuropsychiatric disorders associated with anti-ITK-ALK/ROS1 and their consequences on patients' quality of life in a comprehensive approach.

The DRACONIS project is part of a multidisciplinary and collaborative approach through the establishment of a partnership between researchers, clinicians and representatives of the anti-ITK-ALK/ROS1 France Cancer du Poumon patient association. The project is notably monitored by a joint scientific committee composed of researchers, clinicians, patients and patient caregivers.

Conditions

  • Metastatic Lung Cancer
  • Metastatic Lung Cancer With ALK/ROS1 Fusion

Interventions

OTHER

Assessments of neuropsychiatric, neurocognitive and psychosocial alterations

Assessments will be conducted over two consecutive days or on a separate visit, depending on participant preferences and logistical constraints. The first day will focus on the evaluation of neuropsychiatric and neurocognitive alterations. A comprehensive assessment involving various tools will be carried out by a psychiatrist, a neuropsychologist, and a neurologist. The second day, which may take place on-site or remotely (by telephone or secure videoconference), will be dedicated to psychosocial assessments by a team of social psychologists using a comprehensive qualitative and quantitative approach to quality of life: daily life management, social relationships, and self-image and self-esteem. The collected data will be subjected to a reflexive thematic analysis. The qualitative exploration of quality of life will be complemented by a quantitative assessment using a standardized tool (EORTC QLQ LC13 and C30).

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2027-05-09
Completion
2027-05-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06781905 on ClinicalTrials.gov