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NCT03596866 · ClinicalTrials.gov registry record · Phase 3
A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 248
- Enrollment target
NCT03596866: Completed Phase 3 study, sponsored by Takeda.
NCT03596866 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 248 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03596866, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 248 participants
- Enrollment target
Study Summary
Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: * Brigatinib tablets * Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later.
Primary Outcome
PFS is defined as the time interval from the date of randomization until the first date at which disease progression is objectively documented via RECIST v1.1 by BIRC, or death due to any cause, whichever occurs first, in the full analysis set. PFS was censored for participants without documented disease progression or death at the last valid tumor response assessment.
Interventions
- DRUG Alectinib
- DRUG Brigatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2019-04-19 |
| Est. Completion | 2024-09-18 |
| Phase | Phase 3 |
What the finished NCT03596866 record still lists
NCT03596866 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Alectinib is the first listed.
NCT03596866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03596866 about?
NCT03596866 is a clinical study titled "A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer". Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tum...
What is the current status of trial NCT03596866?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 248 participants. The study started on 2019-04-19. Estimated completion is 2024-09-18.
What interventions are being tested in trial NCT03596866?
The interventions under investigation include: Alectinib (DRUG), Brigatinib (DRUG).
Who is sponsoring clinical trial NCT03596866?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03596866's enrollment target sits among peer trials
248 1266th of 2000 higher than 735 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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