Phase 3 N=956 Randomized Quadruple-blind Treatment

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

Lung Cancer - Non Small Cell Squamous

Bottom Line

View on ClinicalTrials.gov: NCT01285609 ↗

Enrolled (actual)

956

Serious AEs

56.4%

Results posted

Jun 2016

Primary outcome: Primary: Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint — 13.37; 12.42 months — p=0.2517

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ipilimumab (Drug); Placebo (Drug); Paclitaxel (Drug); Carboplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint	13.37; 12.42	0.2517
SECONDARY Overall Survival (OS) in All Randomized Participants at Primary Endpoint	10.94; 10.74	0.2421
SECONDARY Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint	5.55; 5.59	0.0678

Summary

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

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria

Non small cell lung cancer (NSCLC) - squamous cell
Stage IV or recurrent NSCLC
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

Brain Metastases
Autoimmune diseases

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01285609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.