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

Takeda

Status: Completed

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

Treatments: Drug: Alectinib; Drug: Brigatinib; Drug: Any FDA Approved ALK Inhibitors; Drug: Ceritinib; Drug: Lorlatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT03546894

NSCLC-4001

U1111-1213-1757 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

111 participants in 2 patient groups

Brigatinib

Description:

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.

Treatment:

Drug: Brigatinib

Any FDA Approved ALK Inhibitor Other Than Crizotinib

Description:

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.

Treatment:

Drug: Lorlatinib

Drug: Ceritinib

Drug: Any FDA Approved ALK Inhibitors

Drug: Alectinib