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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01900652 | A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants | PHASE2 | COMPLETED | 111 | — | — | Aug 1, 2013 | Mar 1, 2016 | Sep 18, 2019 | 59 | United States, Belgium +8 |
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.
| Arm | Type | Description |
|---|---|---|
| Arm A: Emibetuzumab plus Erlotinib | EXPERIMENTAL | 750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle. |
| Arm B: Emibetuzumab | EXPERIMENTAL | 750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| Emibetuzumab | DRUG | Administered IV |
| Erlotinib | DRUG | Administered Orally |
Inclusion Criteria: * Diagnosis of metastatic Stage IV NSCLC * At least 1 measurable extra-central nervous system (CNS) lesion * Documented radiographic progression while on continuous treatment with erlotinib monotherapy * Objective clinical benefit from erlotinib treatment as defined by either do...