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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04928846 | A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC) | PHASE3 | RECRUITING | 698 | — | — | Mar 25, 2022 | Mar 1, 2028 | Jun 2, 2026 | 317 | United States, Argentina +30 |
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per BICR or death from any cause.
OS is defined as the time from randomization to the event of death from any cause.
| Arm | Type | Description |
|---|---|---|
| Telisotuzumab Vedotin | EXPERIMENTAL | Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. |
| Docetaxel | ACTIVE_COMPARATOR | Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria. |
| Name | Type | Description |
|---|---|---|
| Telisotuzumab Vedotin | BIOLOGICAL | Intravenous (IV) Infusion |
| Docetaxel | DRUG | IV Infusion |
Inclusion Criteria: * Projected life expectancy of at least 12 weeks. * Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay. * Archival or fresh tumor materia...