A Study of Carboplatin and Paclitaxel With or Without MEDI-575 in Untreated, Advanced Non-Small Cell Lung Cancer

Summary

The purpose of this study is to evaluate the dose, antitumor activity, safety and pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with previously untreated, advanced non-small cell lung cancer (NSCLC).

Timeline

Start

2010-12-16

Primary completion

2013-09-11

Completion

2013-09-11

Outcome

Missed primary endpoint

Stopped: “In conjunction with the overall risk-benefit assessment, study was terminated prematurely due to safety concerns.”

registry p = 0.027; Hazard Ratio (HR) 2.205 (95% CI 1.1 to 4.5); Log Rank NCT01268059 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TOVETUMAB	Monoclonal antibody	25 mg/kg	Intravenous
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous

Indications