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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06698042 | A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84) | PHASE3 | ACTIVE NOT_RECRUITING | 67 | — | — | Nov 21, 2024 | Feb 11, 2030 | Apr 1, 2026 | 67 | United States, China +10 |
AUC is defined as area under curve exposure. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab (+) Berahyaluronidase alfa | EXPERIMENTAL | Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course. |
| Pembrolizumab | ACTIVE_COMPARATOR | "Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course, |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab (+) Berahyaluronidase alfa | BIOLOGICAL | Administered subcutaneously on Day 1 of each cycle |
| Pembrolizumab | BIOLOGICAL | Administered intravenously on Day 1 of each cycle |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC). * Measurable disease as assessed by the local site investigator/radiology. Exclusion Criteria: * Diagnosis of small cell lung cancer or, for mixed tumors, prese...