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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05048797 | A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations | PHASE3 | ACTIVE NOT_RECRUITING | 454 | — | — | Oct 28, 2021 | Jul 30, 2027 | Apr 3, 2026 | 130 | United States, Austria +18 |
Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Trastuzumab Deruxtecan (T-DXd) |
| Arm 2 | ACTIVE_COMPARATOR | Standard of Care Treatment (platinum, pemetrexed and pembrolizumab) |
| Name | Type | Description |
|---|---|---|
| Trastuzumab Deruxtecan | DRUG | Trastuzumab Deruxtecan administered by intravenous infusion |
| Cisplatin | DRUG | Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion |
| Carboplatin | DRUG | Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion |
| Pembrolizumab | DRUG | Pembrolizumab administered by intravenous infusion |
| Pemetrexed | DRUG | Pemetrexed administered by intravenous infusion |
Inclusion Criteria: * Participants at least 18 years of age * Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease * Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA * Treatment-naïve for palliative ...