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

Sponsor
Bristol-Myers Squibb
Study ID
NCT02279732
Phase
PHASE3
Status
Completed

Conditions

  • Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — BIOLOGICAL
  • Carboplatin — BIOLOGICAL
  • Ipilimumab — BIOLOGICAL
  • Placebo — OTHER
    0.9% sodium chloride injection, USP, or 5% dextrose injection

Study Details

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.

Key Dates

Start date
Oct 13, 2014
Status verified
Jul 2019
Primary completion
May 3, 2018
Completion
May 3, 2018

Study Design

Enrollment
342 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Carboplatin + Paclitaxel + Ipilimumab
    Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by modified WHO (mWHO) Carboplatin Area Under the Curve (AUC6) IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Ipilimumab 10 mg/kg IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
  • Experimental: Arm 2: Carboplatin + Paclitaxel + Placebo
    Carboplatin AUC6 IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Placebo IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO

Primary Outcome Measure

Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy [ Time Frame: Approximately 43 months post study start ]

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