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A Randomized, Double-Blind, Phase 3 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 3
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

Thank you

Trial Information

A Randomized, Double-Blind, Phase 3 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:



- Disease progression during or after one prior first-line platinum-based chemotherapy
with or without maintenance therapy

- Prior bevacizumab as first-line and/or maintenance therapy is allowed

- Signed informed consent

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- Histologically or cytologically confirmed non small cell lung cancer (NSCLC)

- Stage IV NSCLC disease

- Participants have measurable or nonmeasurable disease

- Adequate organ function, defined as:

- Total bilirubin less than or equal to Upper Limit of Normal (ULN),

- Aspartate Aminotransferase (AST) and Alanine Aminotransaminase (ALT) less than
or equal to 2.5 x ULN, or less than or equal to 5 x ULN if the transferase
elevation is due to liver metastases,

- Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine
clearance greater than or equal to 50 ml/min (per the Cockcroft-Gault formula or
equivalent and/or 24-hour urine collection),

- Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 103/microliters
(µL), hemoglobin greater than or equal to 10.0 grams/deciliter (g/dl), and
platelets greater than or equal to 100 x 103/µL,

- Adequate coagulation function as defined by International Normalized Ratio (INR)
less than or equal to 1.5, or prothrombin time and partial thromboplastin time
less than or equal to 1.5 x ULN.

- The participant does not have cirrhosis at a level of Child-Pugh B (or worse) or
cirrhosis (any degree) and a history of hepatic encephalopathy or clinically
meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is
defined as ascites resulting from cirrhosis and requiring ongoing treatment with
diuretics and/or paracentesis.

- Urinary protein is less than or equal to 1+ on dipstick or routine urinalysis. If
urine dipstick or routine analysis indicates proteinuria greater than or equal to 2+,
a 24-hour urine must be collected and must demonstrate less than 1000 mg of protein

- Participants of reproductive potential (both sexes) must agree to use reliable method
of birth control (hormonal or barrier methods) during the study period and at least
12 weeks after the last dose of study therapy

- Life expectancy of greater than or equal to 3 months

- Prior radiation therapy is allowed if: In the case of chest radiotherapy at least 28
days have elapsed from the completion of radiation treatment prior to randomization;
In the case of focal or palliative radiation treatment at least 7 days have elapsed
from last radiation treatment prior to randomization (and provided that 25% or less
of total bone marrow had been irradiated); In the case of Central Nervous System
(CNS) radiation at least 14 days have elapsed from the completion of radiation
treatment prior to randomization

Exclusion Criteria:

- Disease progression on more than 1 prior chemotherapy regimens

- Participants whose only prior treatment was a tyrosine kinase inhibitor

- The participant's tumor wholly or partially contains small cell lung cancer

- Major surgery within 28 days prior to randomization, or subcutaneous venous access
device placement within 7 days prior to randomization. Postoperative bleeding
complications or wound complications from a surgical procedure performed in the last
2 months

- Concurrent treatment with other anticancer therapy, including other chemotherapy,
immunotherapy, hormonal therapy, chemoembolization, or targeted therapy

- Last dose of bevacizumab must be at least 28 days from time of randomization

- Last dose of cytotoxic chemotherapy must be at least 14 days from time of
randomization

- The participant has untreated CNS metastases. Participants with treated brain
metastases are eligible if they are clinically stable with regard to neurologic
function, off steroids after cranial irradiation ending at least 2 weeks prior to
randomization, or after surgical resection performed at least 28 days prior to
randomization. No evidence of Grade greater than or equal to 1 CNS hemorrhage based
on pretreatment Magnetic Resonance Imaging (MRI) or intravenous (IV) contrast CT scan

- Radiologically documented evidence of major blood vessel invasion or encasement by
cancer

- Radiographic evidence of intratumor cavitation

- History of uncontrolled hereditary or acquired thrombotic disorder

- Chronic therapy with nonsteroidal anti-inflammatory drug (NSAIDs) or other
antiplatelet agents; Aspirin use at doses up to 325 mg/day is permitted

- History of gross hemoptysis (defined as bright red blood or greater than or equal to
1/2 teaspoon) within 2 months prior to randomization

- Clinically relevant congestive heart failure (New York Heart Association [NYHA
II-IV]) or symptomatic or poorly controlled cardiac arrhythmia

- Any arterial thrombotic event, including myocardial infarction, unstable angina,
cerebrovascular accident, or transient ischemic attack, within 6 months prior to
randomization

- Uncontrolled arterial hypertension greater than or equal to 150 / greater than or
equal to 90 mm Hg despite standard medical management

- Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to
randomization

- Significant bleeding disorders, vasculitis, or Grade 3/4 gastrointestinal bleeding
within 3 months prior to randomization

- Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to
randomization

- Bowel obstruction, history or presence of inflammatory enteropathy or extensive
intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea

- Peripheral neuropathy greater than or equal to Grade 2 (National Cancer Institute
Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.02)

- Serious illness or medical condition(s) including, but not limited to: Human
immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome
(AIDS)-related illness; Active or uncontrolled clinically serious infection; Severe
acute or chronic medical or psychiatric condition or laboratory abnormality that may
increase the risk associated with study participation or study drug administration

- Known allergy or hypersensitivity reaction to any of the treatment components

- The participant is pregnant or breastfeeding

- Current or recent (within 28 days prior to randomization) treatment with an
investigational drug or device that has not received regulatory approval for any
indication at the time of randomization, or participation in another interventional
clinical trial

- Prior therapy with docetaxel

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

Baseline to date of death from any cause

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

13852

NCT ID:

NCT01168973

Start Date:

December 2010

Completion Date:

April 2015

Related Keywords:

  • Non Small Cell Lung Cancer
  • second line
  • non small cell lung cancer
  • NSCLC
  • phase 3
  • ramucirumab
  • lung cancer
  • docetaxel
  • taxotere
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Denver, Colorado  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Iowa City, Iowa  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Manhassaet, New York  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Durham, North Carolina  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Phoenix, Arizona  85012
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenbrae, California  94904
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Stamford, Connecticut  06902
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Jacksonville, Florida  32256
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Athens, Georgia  30607
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Chicago, Illinois  60674
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Indianapolis, Indiana  46227
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Overland Park, Kansas  66210
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Metairie, Louisiana  70006
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bethesda, Maryland  20817
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Kalamazoo, Michigan  49048
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Minneapolis, Minnesota  55404
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.St Joseph, Missouri  64507
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Billings, Montana  59101
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Las Vegas, Nevada  89169
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Cincinnati, Ohio  45267
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Tulsa, Oklahoma  74136
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Dunmore, Pennsylvania  18512
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenville, South Carolina  29605
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Memphis, Tennessee  38138
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bedford, Texas  76022
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Norfolk, Virginia  23502
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Seattle, Washington  98133
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Portsmouth, New Hampshire  03801
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Marshfield, Wisconsin  54449
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Little Rock, Arkansas  72205
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Springfield, Massachusetts  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Albuquerque, New Mexico  87106
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Lexington, Kentucky  40536
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Fargo, North Dakota  58122
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Sioux Falls, South Dakota  57104