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

Carcinoma Non-small-cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546894
• Other study ID #: NSCLC-4001
• Secondary ID: U1111-1213-1757
• Status: Completed
• Start date: July 23, 2018
• Est. completion date: February 13, 2023

Study information

• Verified date: November 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: February 13, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anaplastic Lymphoma Kinase-positive
• Carcinoma Non-small-cell Lung
• Lymphoma

Intervention

Drug:
• Brigatinib
Brigatinib tablets.
• Alectinib
Alectinib capsules.
• Ceritinib
Ceritinib capsules.
• Lorlatinib
Lorlatinib capsules.
• Any FDA Approved ALK Inhibitors
FDA approved ALK inhibitors available for treatment.

Locations

Country	Name	City	State
United States	EmpiraMed, Inc.	Maynard	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prescriber-confirmed PFS	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.	Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months)
Secondary	Quality of Life Status Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Lung Cancer (EORTC QLQ-LC13)	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.	Baseline up to treatment cessation or up to approximately 24 months
Secondary	Daily Function Status by M.D. Anderson Symptom Inventory - Lung Cancer (MDASI-LC)	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.	Baseline up to treatment cessation or up to approximately 24 months
Secondary	General Condition Status Using EuroQol Research Foundation EQ-5D-5L	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.	Baseline up to treatment cessation or up to approximately 24 months
Secondary	Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)	The TSQM-9 contains 9 items assessing the following 3 domains: effectiveness (3 items), convenience (3 items) and global satisfaction (3 items).	Baseline up to treatment cessation or up to approximately 24 months
Secondary	Participant-reported PFS	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.	Baseline up to disease progression or death due to any cause, whichever comes first (approximately 24 months)