Observing the safety of brigatinib for lung cancer treatment in adults in South Korea
Post-Marketing Surveillance (Usage Results Study) of Brigatinib in the Treatment of Adult Patients for Approved Indications in South Korea
This study is testing how safe the lung cancer drug brigatinib is for adults in South Korea who are starting treatment for the first time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 257 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | brigatinib |
| Locations | 1 site (Busan) |
| Trial ID | NCT04592523 on ClinicalTrials.gov |
What this trial studies
This observational study aims to estimate the occurrence of adverse events, including serious adverse events, in adult participants with ALK-positive non-small cell lung carcinoma (NSCLC) who are starting treatment with brigatinib for the first time. Conducted in a real-world clinical setting, the study will enroll approximately 257 participants and collect data over a 24-month surveillance period. The data will be gathered from routine and emergency visits and recorded in electronic case report forms to assess the safety and effectiveness of brigatinib under approved indications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with ALK-positive advanced or metastatic non-small cell lung carcinoma who are initiating brigatinib treatment for the first time.
Not a fit: Patients who have previously been treated with brigatinib outside of the approved indications or those for whom brigatinib is contraindicated will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety profile of brigatinib, helping to optimize treatment for patients with ALK-positive NSCLC.
How similar studies have performed: Other studies have shown success in monitoring the safety of cancer treatments in real-world settings, making this approach both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. With ALK-positive advanced or metastatic NSCLC. 2. Who initiate brigatinib for the first time. Exclusion Criteria: 1. Treated with brigatinib outside of the locally approved label in Korea. 2. Whom brigatinib is contraindicated as per product label. 3. Participating in other clinical trials of NSCLC treatment.
Where this trial is running
Busan
- Pusan National University Hospital — Busan, South Korea (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.