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Antidepressant may ease brain fog from lung cancer drug

NCT ID NCT07633626

Symptom relief Sponsor: Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether vortioxetine, an antidepressant known to boost thinking skills, can reduce the mental fogginess caused by the lung cancer drug lorlatinib. About 24 adults with advanced ALK-positive lung cancer who are already taking lorlatinib will receive vortioxetine. Researchers will track changes in memory, attention, and mood over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vortioxetine (an antidepressant)
What this could lead to
If it works, this could point toward a way to manage cognitive side effects from lorlatinib, helping patients think more clearly during treatment.
What could go wrong
This is a small, early observational study with only 24 people, so results may not apply to everyone. It is not a controlled trial, so improvements could be due to other factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults (\>= 18 years) with histologically confirmed advanced (stage IIIB/IV) lung adenocarcinoma harboring ALK or ROS1 fusions, currently receiving lorlatinib as standard care, and initiating vortioxetine for NAE management.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed diagnosis of ALK/ROS1-positive non-small cell lung cancer (NSCLC), stage IIIB/IV. * Currently receiving lorlatinib as part of the standard therapeutic regimen. * Documented neurocognitive adverse events (NAEs) attributable to lorlatinib. * Age \>= 18 years. * ECOG performance status 0-2. * Ability to understand and sign informed consent. * Expected survival \>= 6 months. * Planned initiation of vortioxetine as part of standard care. * Ability to complete neuropsychological tests and questionnaires in Spanish. Exclusion Criteria: * Prior diagnosis of major cognitive impairment unrelated to cancer treatment. * Current use of another antidepressant that cannot be discontinued. * Uncontrolled major psychiatric disorder. * History of uncontrolled epilepsy or recent seizures. * Severe hepatic or renal impairment. * Known hypersensitivity to vortioxetine. * Participation in another clinical trial within the past 30 days. * Inability to provide informed consent. * Life expectancy \< 3 months. * Contraindications to vortioxetine (e.g., concomitant MAOI use). * Prior vortioxetine use. * Severe psychiatric disorders or significant cognitive impairment unrelated to lorlatinib.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma of Lung carcinoma cognitive disorder Cognitive Dysfunction Depression depressive disorder lung adenocarcinoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced ALK/ROS1-positive NSCLC ALK-positive non-small cell lung cancer (NSCLC) Carcinoma, non-small-cell lung (NSCLC) Cognitive dysfunction Depression Lung adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo CTIC

    RECRUITING

    Bogotá, 110131, Colombia

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