A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer Metastatic
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ramucirumab; Placebo; Docetaxel
Intervention description: Administered IV; Administered IV; Administered IV
Intervention MeSH terms: Docetaxel; Ramucirumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 197.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

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.
    

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