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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05152147 | A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers | PHASE3 | ACTIVE NOT_RECRUITING | 920 | — | — | Dec 2, 2021 | Jul 31, 2027 | May 19, 2026 | 227 | Argentina, Australia +31 |
The time from randomization to the date of documented disease progression (per Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1) as assessed by blinded independent central review (BICR) or death from any cause
The time from randomization to death due to any cause
| Arm | Type | Description |
|---|---|---|
| Arm A | ACTIVE_COMPARATOR | Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP) |
| Arm B | EXPERIMENTAL | Zanidatamab plus physician's choice of CAPOX or FP |
| Arm C | EXPERIMENTAL | Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP |
| Name | Type | Description |
|---|---|---|
| Zanidatamab | DRUG | Administered IV |
| Tislelizumab | DRUG | Administered IV |
| Trastuzumab | DRUG | Administered intravenously (IV) |
| Capecitabine | DRUG | Administered orally (PO bid) |
| Oxaliplatin | DRUG | Administered IV |
| Cisplatin | DRUG | Administered IV |
| 5-Fluorouracil | DRUG | Administered IV |
Inclusion Criteria: * Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by I...