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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04704934 | Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04) | PHASE3 | ACTIVE NOT_RECRUITING | 490 | — | — | May 21, 2021 | Aug 31, 2026 | Jan 12, 2026 | 156 | Argentina, Belgium +22 |
Overall survival (OS) is defined as the time from date of randomization until death from any cause.
| Arm | Type | Description |
|---|---|---|
| Trastuzumab deruxtecan | EXPERIMENTAL | Participants who will be randomized to receive a 6.4 mg/kg intravenous (IV) dose of trastuzumab deruxtecan once every 3 weeks on Day 1 of each 21-day cycle. |
| Ramucirumab + paclitaxel | ACTIVE_COMPARATOR | Participants who will be randomized to receive a 8 mg/kg IV dose of ramucirumab on Days 1 and 15 in combination with 80 mg/m\^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| Trastuzumab deruxtecan | DRUG | 6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle |
| Ramucirumab | DRUG | 8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle |
| Paclitaxel | DRUG | 80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle |
Inclusion Criteria: * Adults (according to local regulation) and able to provide informed consent for study participation. * Pathologically documented gastric and GEJ adenocarcinoma that has been previously treated in the metastatic setting (unresectable, locally advanced, or metastatic disease). *...