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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

— Brilliant  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721950
• Other study ID #: Brigatinib-4002
• Status: Recruiting
• Start date: January 17, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 and December 31, 2023.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 the study is approved before December 2023 or it will have retrospective data collection if the study is approved after December 2023. 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 52 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Age = 18 years.

2. Participant with histologically/cytologically confirmed locally advanced or metastatic NSCLC.

3. Participants with ALK gene rearrangement confirmed by local hospital medical records.

4. During the period from September 1, 2022 to December 31, 2023, participants who received brigatinib as first line treatment confirmed by medical records.

5. Participants who have at least one medical record after the start of brigatinib treatment. Exclusion Criteria

1. Participants participated in NSCLC-related interventional clinical trials after locally advanced or metastatic NSCLC diagnosis and during brigatinib treatment.

2. Previously received any other TKIs, including ALK-targeted TKIs.

3. Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.

4. 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• Brigatinib
Brigatinib Tablets

Locations

Country	Name	City	State
China	Department of Oncology, Shanghai pulmonary hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-World Time-to-Treatment Discontinuation (rwTDD)	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.	Up to 52 months
Secondary	Real-World Progression-Free Survival (rwPFS)	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.	Up to 52 months
Secondary	Real-World Progression-Free Survival at Years 1, 2 and 3	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.	Up to 52 months
Secondary	Real-World Overall Survival (rwOS) at Years 1, 2 and 3	rwOS is defined as the time from initiation of brigatinib to death from any cause, or the time of the last confirmed survival.	Up to 52 months
Secondary	Real-World Objective Response Rate (rwORR)	rwORR is defined as the percentage of participants who are confirmed to achieved complete response (CR) or partial response (PR) after receiving brigatinib.	Up to 52 months
Secondary	Real-World Duration of Response (rwDOR)	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.	Up to 52 months