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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05555732 | Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) | PHASE3 | ACTIVE NOT_RECRUITING | 1,170 | — | — | Jan 11, 2023 | May 11, 2029 | Mar 25, 2026 | 254 | United States, Argentina +27 |
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Dato-DXd + Pembrolizumab + Platinum Chemotherapy | EXPERIMENTAL | Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab plus platinum chemotherapy (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC) 5\]). |
| Dato-DXd + Pembrolizumab | EXPERIMENTAL | Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab. |
| Pembrolizumab + Pemetrexed + Platinum Chemotherapy | ACTIVE_COMPARATOR | Participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m\^2 pemetrexed plus platinum chemotherapy (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC) 5\]). |
| Name | Type | Description |
|---|---|---|
| Datopotamab Deruxtecan | DRUG | Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. |
| Pembrolizumab | DRUG | Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. |
| Pemetrexed | DRUG | Pemetrexed will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. |
| Carboplatin | DRUG | Carboplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. |
| Cisplatin | DRUG | Cisplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. |
Key Inclusion Criteria: 1. Sign and date the Main ICF, prior to the start of any study- specific qualification procedures. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions. 2. Adults ≥18 at the time the M...