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Completed

NCT Number: NCT03546894

A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors

The primary purpose of this study is to determine the differences in PFS for participants who have been receiving brigatinib as ALK inhibitor therapy for ALK+NSCLC compared to those participants receiving alectinib, ceritinib, lorlatinib, or other ALK inhibitors that may become available during study treatment.

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Key information

Conditions

Anaplastic Lymphoma Kinase-positive Bronchial Neoplasms Carcinoma Non-small-cell Lung Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

EmpiraMed, Inc.

Maynard, Massachusetts, 01754, United States

About this study

This is a prospective and non-interventional study of participants with ALK+NSCLC. The study will seek to determine the real-world differences in the PFS of participants taking brigatinib or any FDA approved ALK inhibitor other than crizotinib in routine clinical practice and will evaluate participant's quality of life, daily function, general condition, and treatment satisfaction.

The study will enroll approximately 160 participants: 80 participants taking brigatinib, and 80 participants taking FDA approved ALK inhibitors other than crizotinib. Participants will be enrolled in one of the 2 cohorts:

  • Brigatinib
  • Any FDA Approved ALK Inhibitor Other Than Crizotinib

This trial will be conducted in the United States. Upon enrollment into the study, participants will complete a study-specific baseline questionnaire and four validated instrument questionnaires. After that, participants will complete a study-specific monthly questionnaire and four validated instrument questionnaires, which will be made available to participants every 30 days. Participants will be sent automatic e-mail reminders every 30 days when new surveys become available. All participants will receive a notice on completion of their participation in the study at approximately 24 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has ALK+ NSCLC.
  • Has been prescribed:
  • Brigatinib at any point in therapy, OR
  • Any FDA approved ALK inhibitor at any point in therapy other than crizotinib. Participants who were previously on crizotinib, but are now on another ALK inhibitor are eligible for study participation.
  • Has internet access.
  • Is willing to answer regular e-surveys and allow for the prescriber or clinic to provide data on the status of the participant's NSCLC.

Exclusion criteria

  • Has received any investigational compound within 90 days prior to consent.

Treatment and study plan

Brigatinib

Drug

Brigatinib tablets.

Alectinib

Drug

Alectinib capsules.

Ceritinib

Drug

Ceritinib capsules.

Lorlatinib

Drug

Lorlatinib capsules.

Any FDA Approved ALK Inhibitors

Drug

FDA approved ALK inhibitors available for treatment.

Primary outcomes

  1. Prescriber-confirmed PFS

    Time frame: Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months)

    PFS is defined as the time from the date of the first administration of ALK inhibitor to the date of the first documentation of disease progression or death due to any cause, whichever comes first. PFS will be based on prescriber confirmed progression. Participants that withdraw, drop out, or are lost to follow-up before documentation of the events will be censored at the last date at which the participant was determined to be progression-free.

Secondary outcomes

  1. Quality of Life Status Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Lung Cancer (EORTC QLQ-LC13)

    Time frame: Baseline up to treatment cessation or up to approximately 24 months

    EORTC QLQ-LC13 contains 13 questions to assess for: dyspnea, and a series of single items including pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Score of each item will range from 0 to 100, where 0 indicates no symptoms and 100 indicates worst possible symptoms.

  2. Daily Function Status by M.D. Anderson Symptom Inventory - Lung Cancer (MDASI-LC)

    Time frame: Baseline up to treatment cessation or up to approximately 24 months

    The MDASI-LC Module includes 22 questions to assess the severity of multiple lung cancer-related symptoms and the impact of these symptoms on daily functioning. Symptom assessments include: pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling, coughing, constipation, sore throat, general activity, mood, work, relations with others, walking, and enjoyment of life. Scores for each item range from 0 to 10, where 0 indicates no symptoms and 10 indicates worst possible symptoms.

  3. General Condition Status Using EuroQol Research Foundation EQ-5D-5L

    Time frame: Baseline up to treatment cessation or up to approximately 24 months

    The EQ-5D-5L is a standardized non-disease-specific instrument for use as a measure of generic health status. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.

  4. Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)

    Time frame: Baseline up to treatment cessation or up to approximately 24 months

    The TSQM-9 contains 9 items assessing the following 3 domains: effectiveness (3 items), convenience (3 items) and global satisfaction (3 items).

  5. Participant-reported PFS

    Time frame: Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months)

    PFS is defined as the time from the date of the first administration of ALK inhibitor to the date of the first documentation of disease progression or death due to any cause, whichever occurs first. PFS will be based on participant reported progression. Participants that withdraw, drop out, or are lost to follow-up before documentation of the events will be censored at the last date at which the participant was determined to be progression-free.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

An Observational Parallel Group Phase 4 Study to Determine Progression-Free Survival and Evaluate Patient Experience for Patients With Metastatic ALK+ Non-Small Cell Lung Cancer (NSCLC) Treated With ALK Inhibitors

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2018
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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