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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Docetaxel; Ramucirumab

Criteria

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