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.

Status: Active_not_recruiting

Location: See location...

Intervention Type: Drug

Study Type: Observational

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

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• 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.

Locations

Other Locations

China

Department of Oncology, Shanghai pulmonary hospital

Shanghai

Time Frame

Start Date: 2024-01-17

Completion Date: 2028-12-30

Participants

Target number of participants: 154

Treatments

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.

Related Therapeutic Areas

Lung Cancer

ALK-Positive Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer (NSCLC)

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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.

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