Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib
Potential Effect of Vortioxetine on Cognitive Functioning of Patients With ALK-positive Non-Small Cell Lung Cancer Treated With Lorlatinib
This observational study evaluates whether vortioxetine - an antidepressant medication with cognitive-enhancing properties - can reduce the neurological and cognitive side effects associated with lorlatinib treatment in patients with non-small cell lung cancer (NSCLC) harboring ALK or ROS1 gene rearrangements.
Lorlatinib is a highly effective third-generation tyrosine kinase inhibitor, but it causes neuropsychological adverse events (NAEs) in approximately 42% of patients, including cognitive impairment, mood changes, and speech disturbances. Vortioxetine has demonstrated cognitive improvement in depressed patients and in preclinical models of androgen deprivation therapy-induced cognitive impairment.
Twenty-four adult patients with ALK/ROS1-positive NSCLC receiving lorlatinib as standard care and prescribed vortioxetine (10-20 mg/day) for NAE management will be enrolled. Comprehensive neuropsychological assessments and quality-of-life questionnaires will be conducted at baseline, week 6, week 12, and month 6 to document changes in cognitive function, depressive symptoms, and quality of life.
調査の概要
研究の種類
観察的
入学 (推定)
24
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Felipe Canro, MD
- 電話番号：+57 310 8593083
- メール：felipe.canro@gmail.com
研究場所
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Bogotá、コロンビア、110131
- 募集
- Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
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コンタクト：
- Liliana Gutiérrez, RN, MSc
- 電話番号：+573003768158
- メール：lgutierrez@fctic.org
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Psychomotor Speed
時間枠：Baseline, Week 6, Week 12
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Digit Symbol Substitution Test (DSST).
The DSST measures psychomotor speed and sustained attention.
Participants match symbols to digits within a fixed time limit.
Score range: 0 to 90 (number of correct substitutions in 90 seconds); higher scores indicate better cognitive performance.
Within-subject change from baseline analyzed using ANCOVA.
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Baseline, Week 6, Week 12
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Processing Speed and Visual Attention
時間枠：Baseline, Week 6, Week 12
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Trail Making Test Part A (TMT-A).
The TMT-A measures processing speed and visual scanning.
The outcome is time to completion in seconds; lower scores indicate better performance.
Clinically meaningful change assessed using the Reliable Change Index (RCI).
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Baseline, Week 6, Week 12
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Executive Function and Cognitive Flexibility
時間枠：Baseline, Week 6, Week 12
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Trail Making Test Part B (TMT-B).
The TMT-B measures executive function and set-shifting ability.
The outcome is time to completion in seconds; lower scores indicate better performance.
Clinically meaningful change assessed using the Reliable Change Index (RCI).
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Baseline, Week 6, Week 12
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Selective and Sustained Attention
時間枠：Baseline, Week 6, Week 12
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D2-R Test of Attention.
The D2-R Test of Attention measures selective and sustained visual attention.
The primary metric is the Total Concentration Performance score (TN-E), calculated as total items processed minus errors.
Score range: 0 to 299; higher scores indicate better attentional performance.
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Baseline, Week 6, Week 12
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Working Memory
時間枠：Baseline, Week 6, Week 12
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Wechsler Adult Intelligence Scale IV (WAIS-IV), Working Memory Index.
The WAIS-IV Working Memory Index is a standardized composite score derived from Digit Span and Arithmetic subtests.
Score range: 45 to 155 (mean 100, SD 15); higher scores indicate better working memory capacity.
Change from baseline analyzed using linear mixed-effects models (LMM).
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Baseline, Week 6, Week 12
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Processing Speed
時間枠：Baseline, Week 6, Week 12
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Wechsler Adult Intelligence Scale IV (WAIS-IV), Processing Speed Index.
The WAIS-IV Processing Speed Index is a standardized composite score derived from Coding and Symbol Search subtests.
Score range: 45 to 155 (mean 100, SD 15); higher scores indicate better processing speed.
Change from baseline analyzed using LMM.
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Baseline, Week 6, Week 12
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Verbal Learning and Memory
時間枠：Baseline, Week 6, Week 12
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California Verbal Learning Test (CVLT).
The California Verbal Learning Test measures verbal learning and episodic memory across five immediate recall trials plus short- and long-delay recall.
Primary metric: Total Learning Trials 1-5 (score range: 0 to 80); higher scores indicate better verbal memory performance.
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Baseline, Week 6, Week 12
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Language
時間枠：Baseline, Week 6, Week 12
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Phonemic Verbal Fluency Task.
Phonemic verbal fluency is measured by the total number of words beginning with a specified letter generated in 60 seconds.
There is no fixed maximum; higher scores indicate better phonemic language production and frontal-executive function.
The average of three letter trials (F, A, S) will be reported.
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Baseline, Week 6, Week 12
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Language
時間枠：Baseline, Week 6, Week 12
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Semantic Verbal Fluency Task.
Semantic verbal fluency is measured by the total number of words from a specified semantic category generated in 60 seconds.
There is no fixed maximum; higher scores indicate better semantic retrieval and language functioning.
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Baseline, Week 6, Week 12
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Frontal Lobe and Executive Function
時間枠：Baseline, Week 6, Week 12
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INECO Frontal Screening (IFS).
The INECO Frontal Screening (IFS) evaluates frontal lobe functions including motor programming, verbal fluency inhibitory control, working memory, abstraction capacity, and reflex suppression.
Score range: 0 to 30; higher scores indicate better executive and frontal lobe functioning.
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Baseline, Week 6, Week 12
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Subjective Cognitive Complaints
時間枠：Baseline, Week 6, Week 12
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Perceived Deficits Questionnaire (PDQ), Attention/Concentration Subscore.
The PDQ Attention/Concentration subscore measures self-reported cognitive difficulties in attention and concentration.
Subscore range: 0 to 20; higher scores indicate greater perceived cognitive impairment.
Analyzed using mixed models for repeated measures (MMRM).
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Baseline, Week 6, Week 12
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Subjective Cognitive Complaints
時間枠：Baseline, Week 6, Week 12
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Perceived Deficits Questionnaire (PDQ), Planning/Organization Subscore.
The PDQ Planning/Organization subscore measures self-reported difficulties in planning and organizational ability.
Subscore range: 0 to 20; higher scores indicate greater perceived impairment.
Analyzed using MMRM.
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Baseline, Week 6, Week 12
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Clinical Global Impression of Improvement (CGI-I)
時間枠：Baseline, Week 6, Week 12
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The Clinical Global Impressions-Improvement scale (CGI-I) is a clinician-rated measure of overall clinical improvement relative to baseline.
Score range: 1 (very much improved) to 7 (very much worse); lower scores indicate greater improvement.
Response is defined as a score of 1 or 2. Analyzed using MMRM.
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Baseline, Week 6, Week 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Depressive Symptoms
時間枠：Baseline, Week 6, Week 12, Month 6
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Montgomery-Asberg Depression Rating Scale (MADRS).
The MADRS is a clinician-administered scale measuring severity of depressive symptoms across 10 items.
Score range: 0 to 60; higher scores indicate greater depression severity.
Response defined as >= 50% reduction from baseline; remission defined as score < 10.
MCID: >= 50% reduction.
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Baseline, Week 6, Week 12, Month 6
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Depressive Symptoms
時間枠：Baseline, Week 6, Week 12
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Patient Health Questionnaire (PHQ-9).
The PHQ-9 is a 9-item self-report scale for depression screening and severity assessment.
Score range: 0 to 27; higher scores indicate greater depressive symptom burden.
Severity categories: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27).
MCID: >= 5-point reduction.
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Baseline, Week 6, Week 12
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Health-Related Quality of Life
時間枠：Baseline, Month 1, 2, 3, 6, 12
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36-Item Short Form Health Survey (SF-36), Physical Component Summary (PCS).
The SF-36 Physical Component Summary (PCS) is a norm-based composite score derived from four SF-36 subscales (physical functioning, role-physical, bodily pain, general health).
Score range: 0 to 100; higher scores indicate better physical health status.
MCID: >= 4 points.
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Baseline, Month 1, 2, 3, 6, 12
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Health-Related Quality of Life
時間枠：Baseline, Month 1, 2, 3, 6, 12
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36-Item Short Form Health Survey (SF-36), Mental Component Summary (MCS).
The SF-36 Mental Component Summary (MCS) is a norm-based composite score derived from four SF-36 subscales (vitality, social functioning, role-emotional, mental health).
Score range: 0 to 100; higher scores indicate better mental health status.
MCID: >= 4 points.
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Baseline, Month 1, 2, 3, 6, 12
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Life Satisfaction
時間枠：Baseline, Month 1, 2, 3, 6, 12
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Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF).
The Q-LES-Q-SF measures overall enjoyment and satisfaction with daily life across 14 items rated on a 5-point Likert scale (1 = very poor to 5 = very good).
Total score range: 14 to 70; higher scores indicate greater life satisfaction.
Items 15 and 16 are scored separately and not included in the total.
MCID: >= 9 points.
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Baseline, Month 1, 2, 3, 6, 12
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Health Utility
時間枠：Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
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EuroQol 5-Dimension Questionnaire (EQ-5D), Utility Index.
The EQ-5D utility index is derived from five health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) using the Spanish value set.
Score range: -0.654 to 1.0; higher scores indicate better health utility (1.0 = full health, 0 = death).
MCID: >= 0.1.
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
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Self-Rated Health
時間枠：Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
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EuroQol Visual Analogue Scale (EQ-VAS).
The EQ-VAS is a vertical visual analogue scale for overall self-rated health.
Score range: 0 to 100; higher scores indicate better self-rated health (100 = best imaginable health state).
MCID: >= 7 points.
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Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
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Functional Capacity
時間枠：Baseline, Week 6, Week 12
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University of California San Diego Performance-Based Skills Assessment (UPSA), Composite Score.
The UPSA composite score combines the UPSA-VIM and UPSA-Brief to measure real-world functional capacity across domains including finance and communication.
Score range: 0 to 100; higher scores indicate better functional performance.
Analyzed using ANCOVA.
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Baseline, Week 6, Week 12
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Work Limitations
時間枠：Baseline, Week 6, Week 12, Month 6
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Work Limitations Questionnaire (WLQ).
The WLQ measures the degree to which health problems interfere with job performance across four scales: time management, physical demands, mental-interpersonal demands, and output demands.
Each scale is scored 0 to 100; higher scores indicate greater work limitation.
An overall WLQ productivity loss score will also be reported.
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Baseline, Week 6, Week 12, Month 6
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Cognitive and Physical Functioning
時間枠：Baseline, Week 6, Week 12
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Cognitive and Physical Functioning Questionnaire (CPFQ).
The CPFQ is a 7-item self-report instrument measuring cognitive and physical energy symptoms relevant to depression and related conditions.
Score range: 7 to 42; higher scores indicate greater cognitive and physical impairment.
Analyzed only in participants with a baseline score > 25.
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Baseline, Week 6, Week 12
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Tumor Response to Lorlatinib
時間枠：Month 2, Month 6, Month 12
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Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Tumor response is assessed by contrast-enhanced CT scan per RECIST version 1.1 criteria.
Response is classified as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
Best overall response will be documented for each participant.
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Month 2, Month 6, Month 12
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Adverse Events
時間枠：All scheduled visits, from baseline through 30 days post-last visit
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Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
All adverse events (AEs) will be graded by type, severity (Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening; Grade 5: death), and causality attribution (unrelated / unlikely / possible / probable / definitely related to vortioxetine).
Predefined study suspension thresholds: > 25% Grade 3, > 10% Grade 4, or > 3% Grade 5 AEs attributable to vortioxetine.
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All scheduled visits, from baseline through 30 days post-last visit
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月10日
一次修了 (推定)
2027年3月10日
研究の完了 (推定)
2027年11月10日
試験登録日
最初に提出
2026年4月14日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月8日
QC基準を満たした最後の更新が送信されました
2026年6月4日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。