A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer

A Randomized, Double-Blind, Phase 2 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy

The purpose of this study is to evaluate the effects of ramucirumab in combination with docetaxel in participants with Stage IV non-small cell lung cancer who have had disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy for advanced/metastatic disease.

Inclusion Criteria:

• Non-Small Cell Lung Cancer disease
• Clinical stage IV or recurrent disease
• One prior first-line platinum-based chemotherapy regimen with or without maintenance therapy
• For Non-Small Cell Lung Cancer (NSCLC) tumors other than squamous cell histology, the epidermal growth factor receptor (EGFR) mutation status is known prior to randomization
• For participants with activating epidermal growth factor receptor (EGFR) mutation only, prior epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI) monotherapy (only one regimen in the setting of single use) should be utilized
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version RECIST version 1.1
• Adequate organ function
• Estimated life expectancy of at least 3 months.

Exclusion Criteria:

• Have undergone major surgery within 28 days prior to randomization or have planned major surgery during study treatment
• Receiving concurrent treatment with other anticancer therapy
• Central nervous system disease other than stable and treated brain metastasis
• Has major blood vessel invasion or encasement by cancer
• Has intratumor cavitation
• Has a history of uncontrolled thrombotic disorder
• Is receiving therapeutic anticoagulation with drugs
• Is receiving chronic therapy with nonsteroidal anti-inflammatory drugs
• Has a history of hemoptysis within 2 months prior to randomization
• Has clinically relevant congestive heart failure
• Has experienced any arterial thromboembolic event
• Has uncontrolled arterial hypertension
• Has had a serious or nonhealing wound or, ulcer
• Has significant existing conditions