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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Lung Cancer (NSCLC)

Treatments: Biological: Ipilimumab; Other: Placebo; Biological: Carboplatin; Biological: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02279732

2014-002604-25 (EudraCT Number)

CA184-153

Details and patient eligibility

About

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.

Enrollment: 342 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:

• Subjects with NSCLC of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone
• Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification)
• At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Exclusion Criteria:

• Brain metastases
• Malignant pleural effusion that is recurrent
• Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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342 participants in 2 patient groups

Arm 1: Carboplatin + Paclitaxel + Ipilimumab

Experimental group

Description:

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

Treatment:

Biological: Paclitaxel

Biological: Carboplatin

Biological: Ipilimumab

Arm 2: Carboplatin + Paclitaxel + Placebo

Experimental group

Description:

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

Treatment:

Biological: Paclitaxel

Other: Placebo

Biological: Carboplatin