Phase 2
Completed N=197
A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer
Non-small Cell Lung Cancer Metastatic
Source: ClinicalTrials.gov NCT01703091 ↗
Enrolled (actual)
197
Serious AEs
31.8%
Results posted
Jan 2016
Primary outcomePrimary: Progression-Free Survival (PFS) — 5.22; 4.21 Months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
5.22; 4.21 | — |
| SECONDARY Overall Survival (OS) |
15.15; 14.65 | — |
| SECONDARY Percentage of Participants Who Achieved Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)] |
28.9; 18.5 | — |
| SECONDARY Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)] |
78.9; 70.4 | — |
| SECONDARY Change From Baseline in European Quality of Life Questionnaire - 5 Dimension (EQ-5D) Index Score |
-0.024; -0.007; -0.021; 0.006; -0.010; -0.005 | — |
| SECONDARY Change From Baseline in Lung Cancer Symptom Scale (LCSS) |
-12.5; -16.2; -4.9; -7.8; -4.4; -18.3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01703091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.