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

NCT03546894 | Completed FDA Drug

• 2 other identifiers: NSCLC-4001U1111-1213-1757
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  Baseline up to treatment cessation or up to approximately 24 months

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

  Baseline up to treatment cessation or up to approximately 24 months

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

  Baseline up to treatment cessation or up to approximately 24 months

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

  Baseline up to treatment cessation or up to approximately 24 months

• Participant-reported PFS

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

Study Arms (2)

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.

Drug: Brigatinib

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.

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

Interventions

Brigatinib DRUG

Brigatinib tablets.

Brigatinib

Alectinib DRUG

Alectinib capsules.

Any FDA Approved ALK Inhibitor Other Than Crizotinib

Ceritinib DRUG

Ceritinib capsules.

Any FDA Approved ALK Inhibitor Other Than Crizotinib

Lorlatinib DRUG

Lorlatinib capsules.

Any FDA Approved ALK Inhibitor Other Than Crizotinib

Any FDA Approved ALK Inhibitors DRUG

FDA approved ALK inhibitors available for treatment.

Any FDA Approved ALK Inhibitor Other Than Crizotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with ALK+NSCLC and who currently prescribed an ALK inhibitor, except crizotinib.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

EmpiraMed, Inc.

Maynard, Massachusetts, 01754, United States

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

brigatinib; alectinib; ceritinib; lorlatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: July 23, 2018
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)