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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Lung Cancer - Non Small Cell Squamous

Treatments: Drug: Placebo; Drug: Paclitaxel; Drug: Carboplatin; Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01285609

2009-017396-19 (EudraCT Number)

CA184-104

Details and patient eligibility

About

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.

Full description

The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).

Enrollment: 1,289 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,289 participants in 2 patient groups, including a placebo group

Ipilimumab + Paclitaxel and Carboplatin

Experimental group

Description:

Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

Treatment:

Drug: Ipilimumab

Drug: Carboplatin

Drug: Paclitaxel

Placebo + Paclitaxel and Carboplatin

Placebo Comparator group

Description:

Placebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

Treatment:

Drug: Placebo

Drug: Carboplatin

Drug: Paclitaxel