Erlotinib
Drug150 mg orally daily
NCT Number: NCT01887886
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Caen, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
150 mg orally daily
15 mg/kg IV every 3 weeks
IV every 3 weeks
Time frame: approximately 3 years
Time frame: approximately 3 years
Time frame: approximately 3 years
Time frame: approximately 3 years
Time frame: approximately 3 years
Time frame: approximately 3 years
Time frame: Day 1 Cycles 1, 2 and 4
Hoffmann-La Roche
Industry
A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Erlotinib as First-Line Treatment for Patients With MET-Positive Unresectable Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03802240
Non-Squamous Non-Small Cell Lung Cancer
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT01763671
Lung Diseases, Lung Neoplasms
Amiens, France
View Trial DetailsNCT03329911
Non-Squamous Non-Small Cell Lung Cancer
Xiamen, China
View Trial DetailsNCT02264990
Bronchial Neoplasms, Carcinoma, Bronchogenic
Huntsville, Alabama, United States
View Trial Details