NCT01763788

A Study of Necitumumab in the First-Line Treatment of Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

An Open-Label, Multicenter, Phase 1b/2 Study to Evaluate Necitumumab in Combination With Gemcitabine and Cisplatin in the First-Line Treatment of Patients With Advanced (Stage IV) Squamous Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the Phase 1b portion of the study is to investigate how the body tolerates necitumumab, in combination with gemcitabine and cisplatin chemotherapy as first line treatment in participants with Stage IV squamous NSCLC and to determine the recommended dose for the subsequent Phase 2 portion of the study. The purpose of the Phase 2 portion of the study is to evaluate the efficacy of necitumumab in combination with gemcitabine and cisplatin chemotherapy in participants with Stage IV squamous NSCLC in a first-line setting.

Conditions

• Squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Necitumumab	Administered IV
DRUG	Gemcitabine	Administered IV
DRUG	Cisplatin	Administered IV

Timeline

• Start date: 2013-05-07
• Primary completion: 2017-06-28
• Completion: 2018-10-17
• First posted: 2013-01-09
• Last updated: 2019-10-25
• Results posted: 2019-03-22

Locations

20 sites across 1 country: Japan