drugset / Trial / NCT01233687

AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer

NCT01233687

Phase 1/2 Completed 49 enrolled Ahmad Tarhini Amgen · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a phase I/II study of erlotinib and AMG 102 in previously treated subjects with advanced NSCLC. Subjects will be enrolled with recurrent or progressive advanced stage NSCLC that has been treated with at least one and a maximum of two prior chemotherapy regimens. The Phase I part of the study will enroll 8-16 subjects with the Phase II part enrolling 21-45 subjects. The Phase I part of the study is designed to determine how safest the combination of AMG 102 and erlotinib is and the recommended dose for the Phase II part. The Phase II part is to determine whether the combination of AMG102 and erlotinib works enough to warrant further interest in this combination.

Timeline

Start
2011-08
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg
Subject Rilotumumab Monoclonal antibody 5 mg/kg
Subject Rilotumumab Monoclonal antibody 7.5 mg/kg
Subject Rilotumumab Monoclonal antibody 15 mg/kg