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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01233687 | AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer | PHASE1 | COMPLETED | 49 | — | — | Aug 1, 2011 | Nov 1, 2014 | Jun 22, 2017 | 1 | United States |
Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.
Using RECIST v1.1 criteria, DCR was determined by following equation: the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants / the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.
| Arm | Type | Description |
|---|---|---|
| AMG 102 and erlotinib | EXPERIMENTAL | Combination of AMG 102 and erlotinib |
| Name | Type | Description |
|---|---|---|
| AMG 102 and erlotinib | DRUG | Dose Level -2 Dose level -1 Dose Level 0 AMG 102 5 mg/kg 7.5 mg/kg 15 mg/kg Erlotinib 150 mg 150 mg 150 mg The first cohort of patients in the phase I portion will start at dose level 0 of AMG102. |
Patients must have baseline evaluations performed prior to the first dose of study drug and must meet all inclusion and exclusion criteria. Results of all baseline evaluations, which assure that all inclusion and exclusion criteria have been satisfied, must be reviewed by a Physician Investigator pr...