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

Not yet recruiting

• Conditions: Metastatic Lung Cancer; Metastatic Lung Cancer with ALK/ROS1 Fusion

• Registration Number: NCT06781905
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study Start: 2025-01-15
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2027-05-09
• Study Completion: 2027-05-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurocognitive and neuropsychiatric characterization of patients on anti-ITK-ALK/ROS1 targeted therapy who reported treatment-releated neurocognitive and/or neuropsychiatric complaints or disorders	From enrollmenet day 1 visite to the end of the participation, day 2.	Exploratory and comprehensive approach to neurocognitive and neuropsychiatric disorders that may be experienced by patients treated with anti-ALK/ROS1 targeted therapy for ALK/RO1 lung cancer. The characterization of complaints with or without associated neurocognitive and/or neuropsychiatric disorders will be achieved by combining the results of neuropsychological assessments and psychiatric evaluations.

Trial Locations

Locations (2)

Day care Hospital, Pierre Wertheimer Hospital, Civil Hospitals of Lyon; 🇫🇷 Bron, France

Pneumology service, Louis Pradel Hospital, Civil Hospitals of Lyon; 🇫🇷 Bron, France