Clinical trial 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaplastic Lymphoma Kinase-positive
Carcinoma Non-small-cell Lung
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-06-06
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with ALK+NSCLC and who currently prescribed an ALK inhibitor, except crizotinib.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Has ALK+ NSCLC.
2. 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.
3. Has internet access.
4. 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:

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

Primary outcomes:
measure: Prescriber-confirmed PFS
timeFrame: Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months)
Secondary outcomes:
measure: Quality of Life Status Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Lung Cancer (EORTC QLQ-LC13)
timeFrame: Baseline up to treatment cessation or up to approximately 24 months
measure: Daily Function Status by M.D. Anderson Symptom Inventory - Lung Cancer (MDASI-LC)
timeFrame: Baseline up to treatment cessation or up to approximately 24 months
measure: General Condition Status Using EuroQol Research Foundation EQ-5D-5L
timeFrame: Baseline up to treatment cessation or up to approximately 24 months
measure: Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)
timeFrame: Baseline up to treatment cessation or up to approximately 24 months
measure: Participant-reported PFS
timeFrame: Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months)
Other outcomes:
Locations:
city: Maynard
country: United States
facility: EmpiraMed, Inc.
state: Massachusetts
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: