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NCT Number: NCT05721950

A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)

The main aim of this study is to learn about the time between the start and stop of treatment with brigatinib in Chinese participants with non-small-cell lung cancer (NSCLC) and who have been positively diagnosed with having the anaplastic lymphoma kinase (ALK) gene. Other study aims are to learn about the progression of NSCLC and participants' response to treatment with brigatinib.

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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

Department of Oncology, Shanghai pulmonary hospital

Shanghai, Shanghai Municipality, 200433, China

About this study

This is a non-interventional, ambispective (retrospective + prospective) study of Chinese participants with ALK-positive locally advanced or metastatic NSCLC receiving brigatinib as their first line of treatment from September 1, 2022.This study will evaluate the time-to-treatment discontinuation and other efficacy outcomes of brigatinib in participants with NSCLC in real-world settings.

This study will enroll approximately 200 participants in the following cohort:

  • Brigatinib 90 mg/180mg

This study is an ambispective study that will have prospective data collection if participants enrolled after the study initiation or it will have retrospective data collection if the participants have already started receiving brigatinib as first line treatment before study initiation.

This multi-center trial will be conducted in China. Participants will be followed up for safety from signing informed consent until 36 months after the last dose of treatment or until death of the last participant. The overall time for data collection is approximately 8 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years.
  • Participant with histologically/cytologically confirmed locally advanced or metastatic NSCLC.
  • Participants with ALK gene rearrangement confirmed by local hospital medical records.
  • Participants who received brigatinib since September 1, 2022 as first line treatment confirmed by medical records.
  • Participants who have at least one medical record after the start of brigatinib treatment.

Exclusion criteria

  • Participants participated in NSCLC-related interventional clinical trials after locally advanced or metastatic NSCLC diagnosis and during brigatinib treatment.
  • Previously received any other TKIs, including ALK-targeted TKIs.
  • Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
  • Participants have been diagnosed as malignancies (excluding completely resected basal cell carcinoma, bladder carcinoma in situ, cervical carcinoma in situ) in addition to NSCLC within the past 5 years.

Treatment and study plan

Brigatinib

Drug

Brigatinib Tablets

Other names: Alunbrig

Primary outcomes

  1. Real-World Time-to-Treatment Discontinuation (rwTDD)

    Time frame: Up to 8 years

    rwTTD is defined as the time from initiation of brigatinib to discontinuation of treatment for any reason, including disease progression, death, serious adverse events, or participant preference.

Secondary outcomes

  1. Real-World Progression-Free Survival (rwPFS)

    Time frame: Up to 8 years

    rwPFS is defined as the time from initiation of brigatinib to disease progression or death from any cause, or the time of the last confirmed survival.

  2. Real-World Progression-Free Survival at Years 1, 2 and 3

    Time frame: Up to 8 years

    rwPFS at years 1,2 and 3 is defined as the probability of progression-free survival/ survival over one year; the probability of progression-free survival/survival over two years; the probability of progression-free survival/survival over three years.

  3. Real-World Overall Survival (rwOS) at Years 1, 2 and 3

    Time frame: Up to 8 years

    rwOS is defined as the time from initiation of brigatinib to death from any cause, or the time of the last confirmed survival.

  4. Real-World Objective Response Rate (rwORR)

    Time frame: Up to 8 years

    rwORR is defined as the percentage of participants who are confirmed to achieved complete response (CR) or partial response (PR) after receiving brigatinib.

  5. Real-World Duration of Response (rwDOR)

    Time frame: Up to 8 years

    rwDOR is defined as the time from the first assessment of CR or PR after receiving first line treatment with brigatinib to progression or death.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Real-World Study to Evaluate the Effectiveness and Safety of Brigatinib in First Line in Patients With ALK Positive Locally Advanced or Metastatic NSCLC in China: An Ambispective, Non-interventional, Observational, Multi-center Study.

Acronym: Brilliant

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 10, 2023
Registry last updated
Feb 18, 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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