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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05687266 | Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations | PHASE3 | ACTIVE NOT_RECRUITING | 1,350 | — | — | Dec 29, 2022 | Nov 1, 2027 | Apr 22, 2026 | 254 | United States, Austria +21 |
PFS is defined as time from randomisation until progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by BICR, or death due to any cause.
OS is defined as the time from randomisation until the date of death due to any cause.
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
OS is defined as the time from randomisation until the date of death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Dato-DXd + Durvalumab + Carboplatin | EXPERIMENTAL | Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 1120 mg durvalumab plus carboplatin area under the curve \[AUC\] 5 mg/mL/minute. |
| Histologic-specific therapy | ACTIVE_COMPARATOR | Non-squamous NSCLC participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m2 pemetrexed plus either AUC 5 mg/mL/minute carboplatin or 75 mg/m2 cisplatin. Squamous NSCLC participants will be randomized to receive 200 mg of pembrolizumab plus 200 mg/m2 paclitaxel plus AUC 5 or 6 mg/mL/minute carboplatin. |
| Name | Type | Description |
|---|---|---|
| Datopotamab deruxtecan | DRUG | Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
| Durvalumab | DRUG | Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
| Carboplatin | DRUG | Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. |
| Pembrolizumab | DRUG | Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle for a maximum of 35 cycles or 2 years (whichever occurs first). |
| Cisplatin | DRUG | Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. |
| Pemetrexed | DRUG | Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. |
| Paclitaxel | DRUG | Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. |
Inclusion: * Participants ≥ 18 years at screening * Histologically or cytologically documented NSCLC that at the time of randomisation is Stage IIIB or IIIC disease not amenable to surgical resection or definitive chemoradiation or Stage IV metastatic disease * Lacks sensitising EGFR tumour tissue ...