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

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer Metastatic

Treatments: Drug: Docetaxel; Drug: Ramucirumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01703091

14658

I4T-JE-JVCG (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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197 participants in 2 patient groups, including a placebo group

Ramucirumab plus Docetaxel

Experimental group

Description:

Ramucirumab 10 milligram per kilogram (mg/kg) on Day 1 of every 21 day cycle, administered as an intravenous (IV) infusion over approximately 60 minutes. Docetaxel 60 milligram per square meter (mg/m2) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.

Treatment:

Drug: Docetaxel

Drug: Ramucirumab

Placebo plus Docetaxel

Placebo Comparator group

Description:

Placebo (administered at a volume equivalent to a dose of milligram per kilogram (mg/kg)) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes. Docetaxel 60 mg/m2 on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.

Treatment:

Drug: Placebo

Drug: Docetaxel