NCT01168973

Brief Summary

The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,253

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Dec 2010

Typical duration for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
27 countries

231 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 29, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

July 16, 2010

Results QC Date

December 17, 2014

Last Update Submit

September 10, 2019

Conditions

Non-Small Cell Lung Cancer

Keywords

second linenon small cell lung cancerNSCLCphase 3ramucirumablung cancerdocetaxeltaxotere

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.

    Randomization to date of death from any cause (up to 34 months)

Secondary Outcomes (7)

  • Progression-Free Survival (PFS) Time

    Randomization to measured PD or date of death from any cause (up to 29 months)

  • Percentage of Participants Achieving an Objective Response (Objective Response Rate)

    Baseline to measured PD (up to 29 months)

  • Percentage of Participants Achieving Disease Control (Disease Control Rate)

    Baseline to measured PD (up to 29 months)

  • Maximum Improvement on Lung Cancer Symptom Scale (LCSS)

    Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)

  • Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores

    Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)

  • +2 more secondary outcomes

Other Outcomes (1)

  • Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died

    First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle)

Study Arms (2)

Ramucirumab + Docetaxel

EXPERIMENTAL
Biological: RamucirumabDrug: Docetaxel

Placebo + Docetaxel

PLACEBO COMPARATOR
Drug: Placebo (for Ramucirumab)Drug: Docetaxel

Interventions

RamucirumabBIOLOGICAL

10 milligrams per kilogram (mg/kg) administered intravenously (IV) on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Also known as: IMC 1121B, LY3009806
Ramucirumab + Docetaxel
Placebo (for Ramucirumab)DRUG

Administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Placebo + Docetaxel
DocetaxelDRUG

75 milligrams per square meter (mg/m\^2) (60 mg/m\^2 for the countries of Korea and Taiwan only with protocol amendment dated 22 May 2012) administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Placebo + DocetaxelRamucirumab + Docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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 milliliters per minute (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 10\^3/microliters (µL), hemoglobin greater than or equal to 10.0 grams/deciliter (g/dL), and platelets greater than or equal to 100 x 10\^3/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 milligrams (mg) of protein.
  • +3 more criteria

You may not qualify if:

  • 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 IV contrast Computed Tomography (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 milligrams per day (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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (231)

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Phoenix, Arizona, 85016, United States

Location

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Sedona, Arizona, 86336, United States

Location

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Fayetteville, Arkansas, 72703, United States

Location

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Alhambra, California, 91801, United States

Location

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Duarte, California, 91010, United States

Location

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Fresno, California, 93720, United States

Location

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Fullerton, California, 92835, United States

Location

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La Jolla, California, 92093, United States

Location

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Long Beach, California, 90813, United States

Location

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Los Angeles, California, 90095, United States

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Northridge, California, 91325, United States

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Redondo Beach, California, 90277, United States

Location

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Santa Barbara, California, 93105, United States

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Santa Monica, California, 93454, United States

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Denver, Colorado, 80218, United States

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Waterbury, Connecticut, 06708, United States

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Jacksonville, Florida, 32204, United States

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Miami, Florida, 33176, United States

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Ocala, Florida, 34471, United States

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Orlando, Florida, 32806, United States

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Athens, Georgia, 30607, United States

Location

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Augusta, Georgia, 30901, United States

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Lawrenceville, Georgia, 30045, United States

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Macon, Georgia, 31201, United States

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Rome, Georgia, 30165, United States

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Savannah, Georgia, 31405, United States

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Springfield, Illinois, 62703, United States

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Bloomington, Indiana, 47402, United States

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Cedar Rapids, Iowa, 52402, United States

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Iowa City, Iowa, 52242, United States

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Overland Park, Kansas, 66210, United States

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Wichita, Kansas, 67214, United States

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Ashland, Kentucky, 41101, United States

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Mount Sterling, Kentucky, 40353, United States

Location

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Baton Rouge, Louisiana, 70809, United States

Location

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Metairie, Louisiana, 70006, United States

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Bethesda, Maryland, 20817, United States

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Chevy Chase, Maryland, 20815, United States

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Boston, Massachusetts, 02115, United States

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Danvers, Massachusetts, 01923, United States

Location

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Framingham, Massachusetts, 01701, United States

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Newton, Massachusetts, 02462, United States

Location

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Ann Arbor, Michigan, 48109, United States

Location

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Minneapolis, Minnesota, 55404, United States

Location

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Columbia, Missouri, 65201, United States

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Joplin, Missouri, 64804, United States

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St Louis, Missouri, 63110, United States

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Billings, Montana, 59101, United States

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Henderson, Nevada, 89169, United States

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Reno, Nevada, 89502, United States

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Lebanon, New Hampshire, 03756, United States

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Portsmouth, New Hampshire, 03801, United States

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Albuquerque, New Mexico, 87109, United States

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Latham, New York, 12110, United States

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New York, New York, 10021, United States

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The Bronx, New York, 10467, United States

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Durham, North Carolina, 27704, United States

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Raleigh, North Carolina, 27607, United States

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Fargo, North Dakota, 58122, United States

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Columbus, Ohio, 43219, United States

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Tulsa, Oklahoma, 74136, United States

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Abington, Pennsylvania, 19001, United States

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Kingston, Pennsylvania, 18704, United States

Location

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Philadelphia, Pennsylvania, 19106, United States

Location

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Charleston, South Carolina, 29414, United States

Location

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Sioux Falls, South Dakota, 57104, United States

Location

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Chattanooga, Tennessee, 37403, United States

Location

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Memphis, Tennessee, 38138, United States

Location

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Abilene, Texas, 79606, United States

Location

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Amarillo, Texas, 79106, United States

Location

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Beaumont, Texas, 77702, United States

Location

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Bedford, Texas, 76022, United States

Location

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Dallas, Texas, 75231, United States

Location

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El Paso, Texas, 79915, United States

Location

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Fort Worth, Texas, 76104, United States

Location

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Lewisville, Texas, 75067, United States

Location

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McAllen, Texas, 78503, United States

Location

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Mesquite, Texas, 75150, United States

Location

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Midland, Texas, 79701, United States

Location

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Odessa, Texas, 79761, United States

Location

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Paris, Texas, 75460, United States

Location

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San Antonio, Texas, 78212, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Sherman, Texas, 75090, United States

Location

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Sugar Land, Texas, 77479, United States

Location

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The Woodlands, Texas, 77380, United States

Location

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Tyler, Texas, 75702, United States

Location

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Webster, Texas, 77598, United States

Location

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Wichita Falls, Texas, 76310, United States

Location

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Christiansburg, Virginia, 24073, United States

Location

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Fairfax, Virginia, 22031, United States

Location

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Newport News, Virginia, 23601, United States

Location

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Richmond, Virginia, 23298, United States

Location

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Lacey, Washington, 98503, United States

Location

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Spokane, Washington, 99216, United States

Location

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Wenatchee, Washington, 98801, United States

Location

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Madison, Wisconsin, 53705, United States

Location

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Buenos Aires, C1417EYG, Argentina

Location

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Córdoba, X5016KEH, Argentina

Location

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La Rioja, 5300, Argentina

Location

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Rosario, 2000, Argentina

Location

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Tucumain, 4000, Argentina

Location

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Viedma, 8500, Argentina

Location

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Graz, 8036, Austria

Location

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Grimmenstein, 2840, Austria

Location

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Vienna, A-1140, Austria

Location

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Wels, 4600, Austria

Location

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Barretos, 14784700, Brazil

Location

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Belo Horizonte, 31110580, Brazil

Location

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Goiânia, 74140050, Brazil

Location

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Porto Alegre, 90430-090, Brazil

Location

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São Paulo, 1224010, Brazil

Location

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Edmonton, Alberta, T6G 1Z2, Canada

Location

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Moncton, New Brunswick, E1C 6Z8, Canada

Location

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Sainte-Foy, Quebec, G1V 4G5, Canada

Location

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Grenoble, 38049, France

Location

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Lille, 59037, France

Location

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Lyon, 69373, France

Location

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Nice, 06050, France

Location

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Strasbourg, 67091, France

Location

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Toulouse, 31059, France

Location

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Vandœuvre-lès-Nancy, 54511, France

Location

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Augsburg, 86150, Germany

Location

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Bad Soden, 65812, Germany

Location

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Bielefeld, 33611, Germany

Location

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Dresden, 01307, Germany

Location

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Frankfurt, 60596, Germany

Location

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Gerlingen, 70839, Germany

Location

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Großhansdorf, 22927, Germany

Location

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Halle, 06120, Germany

Location

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Heidelberg, 69126, Germany

Location

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Immenhausen, 34376, Germany

Location

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Oldenburg, 26121, Germany

Location

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Ulm, 89081, Germany

Location

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Villingen-Schwenningen, 78050, Germany

Location

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Athens, 10676, Greece

Location

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Chania, 73300, Greece

Location

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Kifissia, 14564, Greece

Location

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Pátrai, 26500, Greece

Location

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Budapest, 1145, Hungary

Location

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Gyula, 5703, Hungary

Location

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Mátraháza, 3233, Hungary

Location

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Nyíregyháza, 4412, Hungary

Location

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Pécs, 7623, Hungary

Location

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Székesfehérvár, 8000, Hungary

Location

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Bangalore, 560099, India

Location

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Cuttack, 753007, India

Location

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Delhi, 110085, India

Location

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Jaipur, 302017, India

Location

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Kochi, 628040, India

Location

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Madurai, 625020, India

Location

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Mumbai, 400 012, India

Location

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Pune, 411001, India

Location

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Trivandrum, 695 011, India

Location

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Haifa, 31096, Israel

Location

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Jerusalem, 91120, Israel

Location

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Kfar Saba, 44281, Israel

Location

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Petah Tikva, 49100, Israel

Location

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Safed, 13110, Israel

Location

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Tel Aviv, 64239, Israel

Location

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Livorno, 57124, Italy

Location

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Monza, 20900, Italy

Location

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Novara, 28100, Italy

Location

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Padua, 35128, Italy

Location

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Palermo, 90146, Italy

Location

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Parma, 43100, Italy

Location

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Pisa, 56124, Italy

Location

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Rome, 00152, Italy

Location

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Guadalajara, 44280, Mexico

Location

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Mexico City, 14000, Mexico

Location

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's-Hertogenbosch, 5223 GZ, Netherlands

Location

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Amsterdam, 1091AC, Netherlands

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Arnhem, 6815 AD, Netherlands

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Harderwijk, 3844 DG, Netherlands

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Zwolle, 80211 JW, Netherlands

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Grafton, 1023, New Zealand

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Wellington, 6002, New Zealand

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Oslo, 0310, Norway

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Tromsø, 9012, Norway

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Gdansk, 80-219, Poland

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Gdynia, 81-519, Poland

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Głuchołazy, 48-340, Poland

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Krakow, 31-202, Poland

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Lodz, 90-242, Poland

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Opole, 45-060, Poland

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Otwock, 05-400, Poland

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Poznan, 60-693, Poland

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Bayamón, 00959, Puerto Rico

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Bucharest, 022328, Romania

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Cluj-Napoca, 400058, Romania

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Iași, 700106, Romania

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Moscow, 115478, Russia

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Saint Petersburg, 197758, Russia

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Stavropol, 355047, Russia

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Incheon, 405-760, South Korea

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Seoul, 120-752, South Korea

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Suwon, 442-723, South Korea

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Barcelona, 08003, Spain

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Girona, 17007, Spain

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Las Palmas de Gran Canaria, 35016, Spain

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Madrid, 28050, Spain

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Mataró, 08304, Spain

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Pamplona, 31008, Spain

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Pozuelo de Alarcón, 28223, Spain

Location

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Eskilstuna, 63188, Sweden

Location

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Linköping, 58185, Sweden

Location

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Lund, 22185, Sweden

Location

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Solna, 17176, Sweden

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Basel, CH-4031, Switzerland

Location

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Bern, CH-3010, Switzerland

Location

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Fribourg, 1708, Switzerland

Location

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Lucerne, CH-6000, Switzerland

Location

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Zurich, CH-8091, Switzerland

Location

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Kaohsiung City, 813, Taiwan

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Kuei Shan Hsiang, 33305, Taiwan

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Neihu Taipei, 114, Taiwan

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Niao Sung Hsiang, 833, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 11031, Taiwan

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Ankara, 06500, Turkey (Türkiye)

Location

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Istanbul, 81540, Turkey (Türkiye)

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Izmir, 35340, Turkey (Türkiye)

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Kayseri, 38039, Turkey (Türkiye)

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Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

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London, Greater London, W6 8RF, United Kingdom

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Preston, Lancashire, PR2 9HT, United Kingdom

Location

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Wythenshawe, Manchester, M23 9LT, United Kingdom

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Scunthorpe, North Lincolnshire, DN15 7BH, United Kingdom

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Glasgow, Scotland, G12 0YN, United Kingdom

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Coventry, West Midlands, CV2 2DX, United Kingdom

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Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Related Publications (4)

  • Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.

    PMID: 35930972DERIVED

  • Garon EB, Scagliotti GV, Gautschi O, Reck M, Thomas M, Iglesias Docampo L, Kalofonos H, Kim JH, Gans S, Brustugun OT, Orlov SV, Cuyun Carter G, Zimmermann AH, Oton AB, Alexandris E, Lee P, Wolff K, Stefaniak VJ, Socinski MA, Perol M. Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy. ESMO Open. 2020 Jan;5(1):e000567. doi: 10.1136/esmoopen-2019-000567.

    PMID: 31958290DERIVED

  • Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S, Perol M. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014 Aug 23;384(9944):665-73. doi: 10.1016/S0140-6736(14)60845-X. Epub 2014 Jun 2.

    PMID: 24933332DERIVED

  • Garon EB, Cao D, Alexandris E, John WJ, Yurasov S, Perol M. A randomized, double-blind, phase III study of Docetaxel and Ramucirumab versus Docetaxel and placebo in the treatment of stage IV non-small-cell lung cancer after disease progression after 1 previous platinum-based therapy (REVEL): treatment rationale and study design. Clin Lung Cancer. 2012 Nov;13(6):505-9. doi: 10.1016/j.cllc.2012.06.007. Epub 2012 Jul 31.

    PMID: 22853980DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

RamucirumabDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Limitations and Caveats

Three participants randomized to placebo and docetaxel received 1 dose of ramucirumab in error. They are included in the placebo and docetaxel arm in the ITT population and are included in the ramucirumab and docetaxel arm in the Safety population.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

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

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 23, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

August 1, 2016

Last Updated

September 25, 2019

Results First Posted

December 29, 2014

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

BR(5)NZ(2)AU(4)ME(2)TU(4)GB(8)SE(4)NO(2)IN(9)IL(6)US(97)FR(7)GR(4)HU(6)NL(5)AR(6)PR(1)RO(3)PL(8)RU(3)IT(8)DE(13)KR(3)ES(7)CA(3)CH(5)TW(6)