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

NCT ID: NCT03546894

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 111 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2023-02-13

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Brigatinib

The dosage and regimen of brigatinib (ALK inhibitors) will be decided by participant's prescribing physician and will not be determined by participation in the study.

Brigatinib

Intervention Type: DRUG

Brigatinib tablets.

Any FDA Approved ALK Inhibitor Other Than Crizotinib

The dosage, regimen of any Food and Drug Administration (FDA) approved ALK inhibitor (at any point in therapy) other than crizotinib will be decided by participant's prescribing physician and will not be determined by participation in the study.

Alectinib

Intervention Type: DRUG

Alectinib capsules.

Ceritinib

Intervention Type: DRUG

Ceritinib capsules.

Lorlatinib

Intervention Type: DRUG

Lorlatinib capsules.

Any FDA Approved ALK Inhibitors

Intervention Type: DRUG

FDA approved ALK inhibitors available for treatment.

Interventions

Brigatinib

Brigatinib tablets.

Intervention Type: DRUG

Alectinib

Alectinib capsules.

Intervention Type: DRUG

Ceritinib

Ceritinib capsules.

Intervention Type: DRUG

Lorlatinib

Lorlatinib capsules.

Intervention Type: DRUG

Any FDA Approved ALK Inhibitors

FDA approved ALK inhibitors available for treatment.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

EmpiraMed, Inc.

Maynard, Massachusetts, United States

Countries

United States

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b60294db2bf003ab499b0??page=1&idFilter=NSCLC-4001

To obtain more information on the study, click this link.

Other Identifiers

U1111-1213-1757

Identifier Type: REGISTRY

Identifier Source: secondary_id

NSCLC-4001

Identifier Type: -

Identifier Source: org_study_id