Thinking and mood changes from ALK/ROS1 targeted drugs in metastatic lung cancer and a patient-research care pathway
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
Hospices Civils de Lyon · NCT06781905
This project will look at thinking, memory, and mood changes in adults in France taking ALK/ROS1-targeted drugs for metastatic lung cancer to see how these effects affect daily life and to build a patient-research care pathway.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Drugs / interventions | brigatinib, alectinib, lorlatinib, chemotherapy |
| Locations | 2 sites (Bron and 1 other locations) |
| Trial ID | NCT06781905 on ClinicalTrials.gov |
What this trial studies
This observational project enrolls adults treated with oral ALK/ROS1-targeted therapies for metastatic lung cancer who report cognitive or psychiatric symptoms. Participants identified by their prescribing physician will undergo standardized neurocognitive testing, neuropsychiatric evaluations, questionnaires, and semi-structured interviews to document the nature, frequency, and severity of symptoms. The study aims to quantify how often these problems occur, describe their clinical profile, and map their impact on quality of life and daily functioning. Findings will be used to co-design a collaborative patient–researcher care and follow-up pathway tailored to these side effects.
Who should consider this trial
Good fit: Adults (18+) who are fluent in French, currently treated with anti-ITK-ALK/ROS1 for ALK/ROS1-positive metastatic lung cancer, and identified by their doctor as having treatment-related cognitive or psychiatric complaints are ideal candidates.
Not a fit: Patients with pre-existing neurocognitive or psychiatric disorders before starting ALK/ROS1 therapy, uncontrolled brain metastases or carcinomatous meningitis, inadequate French proficiency, or severe unstable medical conditions are unlikely to qualify or to gain direct benefit.
Why it matters
Potential benefit: If successful, the work could lead to earlier recognition and tailored support for thinking and mood problems that improve daily functioning and quality of life.
How similar studies have performed: Published reports of cognitive and psychiatric effects from targeted ALK/ROS1 therapies are limited and mainly descriptive, so this collaborative pathway approach is relatively novel rather than proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bron and 1 other locations
- 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)
Study contacts
- Study coordinator: Michael DURUISSEAUX, Professor
- Email: michael.duruisseaux@chu-lyon.fr
- Phone: +33 4 72 35 76 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Lung Cancer, Metastatic Lung Cancer With ALK/ROS1 Fusion, Neurocognitive disorders, Targeted therapies, Quality of life, Lung cancer, Collaborative research, Care pathway