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

NCT05721950 | Active Not Recruiting

• 1 other identifier: Brigatinib-4002
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Drug Therapy; Real-world Data; Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors

Outcome Measures

Primary Outcomes (1)

• 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 8 years

Secondary Outcomes (5)

• Real-World Progression-Free Survival (rwPFS)

  Up to 8 years

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

  Up to 8 years

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

  Up to 8 years

• Real-World Objective Response Rate (rwORR)

  Up to 8 years

• Real-World Duration of Response (rwDOR)

  Up to 8 years

Study Arms (1)

Brigatinib 90 mg/180mg

Participants with ALK positive locally advanced or metastatic NSCLC will be observed ambispectively (retrospective plus prospective) after receiving recommended dose of brigatinib, 90 mg orally once daily for first 7 days followed by 180 mg once daily for up to 36 months as their first line of treatment as part of routine medical care. Data will be collected every 3 months after their first dose until the 36 month or participant death, loss to follow-up, or withdrawal from the study for any reason in the real-world setting from September 1, 2022.

Drug: Brigatinib

Interventions

Brigatinib DRUG

Brigatinib Tablets

Also known as: Alunbrig

Brigatinib 90 mg/180mg

Eligibility Criteria

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

Study Population

Participants diagnosed with ALK positive locally advanced or metastatic NSCLC who received/will receive brigatinib in first line treatment since September 1, 2022 in China.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Department of Oncology, Shanghai pulmonary hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Links

• Click here for more information about this trial in easy-to-understand language.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens collected would be blood and urine samples. They would be used for blood biochemistry coagulation function tests, ALK genetic testing methods and results, and post-resistance gene testing.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

brigatinib

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: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: January 17, 2024
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

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

CN (1)