OncRef

Clinical Trial: NCT00981058

First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Eli Lilly and Company
Information Provided By:Eli Lilly and Company
Last Update Posted:2025-06-18

Study Overview

Brief Summary

The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.

Official Title

A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Conditions

Non Small Cell Lung Cancer

Intervention / Treatment

  • Biological: Necitumumab
  • Drug: Gemcitabine
  • Drug: Cisplatin

Other Study ID Numbers

  • 13909
  • CP11-0806
  • I4X-IE-JFCC
  • 2009-013838-25
  • 2009

Start Date (Actual)

2010-01-07

Primary Completion Date (Actual)

2013-06-17

Study Completion Date (Actual)

2024-05-30

Enrollment (Actual)

1093

Study Type

Interventional

Phase

Phase 3