Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer metastatic
Treatments ramucirumab, placebo, docetaxel
Phase phase 2
Target VEGF
Sponsor Eli Lilly and Company
Start date December 2012
End date December 2014
Trial size 220 participants
Trial identifier NCT01703091, 14658, I4T-JE-JVCG

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
ramucirumab LY 3009806
Administered IV
docetaxel
Administered IV
(Placebo Comparator)
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.
placebo
Administered IV
docetaxel
Administered IV

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Baseline to Measured Progressive Disease or Death from Any Cause (estimated up to 28 months)

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Baseline to Death from Any Cause (estimated up to 28 months)
Number of Participants who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])
time frame: Baseline to Measured Progressive Disease or Participant Stops Study (estimated up to 28 months)
Number of Participants who Achieve Best Overall Disease Response of Complete Response, Partial Response or Stable Disease (Disease Control Rate[DCR])
time frame: Baseline to Measured Progressive Disease or Participant Stops Study (estimated up to 28 months)
Change from Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
time frame: Baseline to Measured Progressive Disease or Participant Stops Study (estimated up to 28 months)
Change from Baseline in Lung Cancer Symptom Scale (LCSS)
time frame: Baseline to Measured Progressive Disease or Participant Stops Study (estimated up to 28 months)

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.