NCT02279732

Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin

A Randomized, Multicenter, Double-Blind, Multinational, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non-Small Cell Lung Cancer (NSCLC) With Squamous Histology

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

Conditions

• Lung Cancer (NSCLC)

Interventions

Type	Name	Description
BIOLOGICAL	Paclitaxel
BIOLOGICAL	Carboplatin
BIOLOGICAL	Ipilimumab
OTHER	Placebo	0.9% sodium chloride injection, USP, or 5% dextrose injection

Timeline

• Start date: 2014-10-13
• Primary completion: 2018-05-03
• Completion: 2018-05-03
• First posted: 2014-10-31
• Last updated: 2019-08-28
• Results posted: 2019-08-28

Locations

49 sites across 6 countries: China, Germany, Hungary, Poland, Singapore, South Korea