Thinking and mood changes from ALK/ROS1 targeted drugs in metastatic lung cancer and a patient-research care pathway

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.