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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


Phase 2
20 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer Metastatic

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Trial Information

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


Inclusion Criteria:



- Non-squamous 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Time Frame:

Baseline to Measured Progressive Disease or Death from Any Cause (estimated up to 28 months)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

14658

NCT ID:

NCT01703091

Start Date:

December 2012

Completion Date:

February 2015

Related Keywords:

  • Non-small Cell Lung Cancer Metastatic
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

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