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NCT Number: NCT05735327

A Study of Brigatinib as Preferred First Therapy for Adults With Non-Small Cell Lung Cancer (NSCLC) ENTIRETY

This is a study of brigatinib in adults with Non-Small Cell Lung Cancer (NSCLC). The main aim of this study is to learn about the time period in which the condition does not worsen after the participant has received brigatinib. Another aim is to learn about the overall rate of participants who respond to the treatment with brigatinib.

Participants will receive brigatinib as part of their normal clinical practice. Data will be collected during regular visits to the hospital (a total of up to 12 visits is planned throughout study duration).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dolnoslskie Centrum Onkologii, Pulmonologii i Hematologii, Wroclaw, Dolnoslskie, Poland

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About this study

This is a non-interventional, prospective study of Polish participants with ALK positive NSCLC receiving Brigatinib as their first line of treatment in the scope of routine clinical practice within the frames of National Drug Program (NDP). This study will evaluate progression-free survival (from the time of the first dose of brigatinib).

This study will enrol approximately 50 participants. Participants will be enrolled in the following cohort to be observed at baseline, and every 3 months up to 33 months:

  • Brigatinib

This multi-center trial will be conducted in Poland. The overall duration of the study will include approximately 18 months of enrolment and approximately 33 months of data collection and follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (aged ≥18) ALK positive NSCLC participants receiving brigatinib as a first-line treatment in the scope of NDP.
  • Participants willing to participate in the study and signed ICF.

Exclusion criteria

  • Current or planned participation in an interventional clinical trial for ALK positive non-small cell lung cancer (NSCLC).
  • Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Treatment and study plan

No intervention

Drug

As this is an observational study, no intervention will be administered.

Primary outcomes

  1. Real-World Progression Free Survival (rwPFS)

    Time frame: Up to 33 months

    rwPFS is defined as the time from starting treatment to the time of radiographic progression according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 33 months

    OS is defined as the time from starting treatment with brigatinib until death due to any cause or loss to follow-up.

  2. Real-World Overall Response Rate (rwORR)

    Time frame: Up to 33 months

    rwORR (including intracranial response) is defined as the sum of the partial and complete response according to RECIST version 1.1. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.

  3. Time to Discontinuation (TTD)

    Time frame: Up to 33 months

    TTD is defined as the time from starting treatment to the time to treatment discontinuation due to any cause.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Effectiveness and Safety of Brigatinib Treatment as First-line Therapy Administered to ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients. Prospective, Multicenter, Observational Study

Acronym: ENTIRETY

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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