Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03596866 | A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer | PHASE3 | COMPLETED | 248 | — | — | Apr 19, 2019 | Sep 18, 2024 | Sep 12, 2025 | 114 | United States, Argentina +18 |
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.
| Arm | Type | Description |
|---|---|---|
| Brigatinib | EXPERIMENTAL | Participants were administered brigatinib 90 milligrams (mg), tablets, orally, once daily (QD) for 7 days, followed by brigatinib 180 mg, tablets, orally, QD until objective disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator, or intolerable toxicity, or up to 63.47 months. |
| Alectinib | ACTIVE_COMPARATOR | Participants were administered alectinib 600 mg, capsules, orally, twice daily (BID) until objective disease progression per RECIST v1.1, as assessed by the investigator, or intolerable toxicity, or up to 59.83 months. |
| Name | Type | Description |
|---|---|---|
| Brigatinib | DRUG | Brigatinib Tablets. |
| Alectinib | DRUG | Alectinib Capsules. |
Inclusion Criteria: 1. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 2. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent) or stage IV NSCLC. 3. Must meet one of the following criteria: * Have documentation of ALK rearrangeme...