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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01966003 | Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer | PHASE3 | COMPLETED | 642 | — | — | Nov 11, 2013 | Jul 23, 2015 | Oct 19, 2017 | 4 | United States, Australia +1 |
Tumor assessments were performed by central, independent, blinded radiologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest and abdomen. Objective response is defined as a best overall response of partial response (PR) or complete response (CR) as defined by RECIST v1.1. All participants who did not meet the criteria for CR or PR by the end of the study were considered non-responders. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must be reduced in short axis to \< 10 mm. PR: Disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions, or, at least a 30% decrease in the sum of diameters of target lesions, with no progression of existing non-target lesions and no new lesions.
| Arm | Type | Description |
|---|---|---|
| ABP 215 | EXPERIMENTAL | Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles. |
| Bevacizumab | ACTIVE_COMPARATOR | Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles. |
| Name | Type | Description |
|---|---|---|
| Carboplatin | DRUG | Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W |
| Paclitaxel | DRUG | Administered 200 mg/m² IV Q3W |
| ABP 215 | DRUG | Administered 15 mg/kg Q3W by IV infusion |
| Bevacizumab | DRUG | Administered 15 mg/kg Q3W by IV infusion |
Inclusion Criteria: * Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) * Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy * Eastern Cooperat...