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
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
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.
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 NSCLC
Stage IV NSCLC disease
Participants have measurable or nonmeasurable disease
Adequate organ function, defined as:
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.
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:
Phoenix, Arizona 85016, United States
Sedona, Arizona 86336, United States
Fayetteville, Arkansas 72703, United States
Alhambra, California 91801, United States
Duarte, California 91010, United States
Fresno, California 93720, United States
Fullerton, California 92835, United States
La Jolla, California 92093, United States
Long Beach, California 90813, United States
Los Angeles, California 90095, United States
Northridge, California 91325, United States
Redondo Beach, California 90277, United States
Santa Barbara, California 93105, United States
Santa Monica, California 93454, United States
Denver, Colorado 80218, United States
Waterbury, Connecticut 06708, United States
Jacksonville, Florida 32204, United States
Miami, Florida 33176, United States
Ocala, Florida 34471, United States
Orlando, Florida 32806, United States
Athens, Georgia 30607, United States
Augusta, Georgia 30901, United States
Lawrenceville, Georgia 30045, United States
Macon, Georgia 31201, United States
Rome, Georgia 30165, United States
Savannah, Georgia 31405, United States
Springfield, Illinois 62703, United States
Bloomington, Indiana 47402, United States
Cedar Rapids, Iowa 52402, United States
Iowa City, Iowa 52242, United States
Overland Park, Kansas 66210, United States
Wichita, Kansas 67214, United States
Ashland, Kentucky 41101, United States
Mount Sterling, Kentucky 40353, United States
Baton Rouge, Louisiana 70809, United States
Metairie, Louisiana 70006, United States
Bethesda, Maryland 20817, United States
Chevy Chase, Maryland 20815, United States
Boston, Massachusetts 02115, United States
Danvers, Massachusetts 01923, United States
Framingham, Massachusetts 01701, United States
Newton, Massachusetts 02462, United States
Ann Arbor, Michigan 48109, United States
Minneapolis, Minnesota 55404, United States
Columbia, Missouri 65201, United States
Joplin, Missouri 64804, United States
St Louis, Missouri 63110, United States
Billings, Montana 59101, United States
Henderson, Nevada 89169, United States
Reno, Nevada 89502, United States
Lebanon, New Hampshire 03756, United States
Portsmouth, New Hampshire 03801, United States
Albuquerque, New Mexico 87109, United States
Latham, New York 12110, United States
New York, New York 10021, United States
The Bronx, New York 10467, United States
Durham, North Carolina 27704, United States
Raleigh, North Carolina 27607, United States
Fargo, North Dakota 58122, United States
Columbus, Ohio 43219, United States
Tulsa, Oklahoma 74136, United States
Abington, Pennsylvania 19001, United States
Kingston, Pennsylvania 18704, United States
Philadelphia, Pennsylvania 19106, United States
Charleston, South Carolina 29414, United States
Sioux Falls, South Dakota 57104, United States
Chattanooga, Tennessee 37403, United States
Memphis, Tennessee 38138, United States
Abilene, Texas 79606, United States
Amarillo, Texas 79106, United States
Beaumont, Texas 77702, United States
Bedford, Texas 76022, United States
Dallas, Texas 75231, United States
El Paso, Texas 79915, United States
Fort Worth, Texas 76104, United States
Lewisville, Texas 75067, United States
McAllen, Texas 78503, United States
Mesquite, Texas 75150, United States
Midland, Texas 79701, United States
Odessa, Texas 79761, United States
Paris, Texas 75460, United States
San Antonio, Texas 78212, United States
San Antonio, Texas 78229, United States
Sherman, Texas 75090, United States
Sugar Land, Texas 77479, United States
The Woodlands, Texas 77380, United States
Tyler, Texas 75702, United States
Webster, Texas 77598, United States
Wichita Falls, Texas 76310, United States
Christiansburg, Virginia 24073, United States
Fairfax, Virginia 22031, United States
Newport News, Virginia 23601, United States
Richmond, Virginia 23298, United States
Lacey, Washington 98503, United States
Spokane, Washington 99216, United States
Wenatchee, Washington 98801, United States
Madison, Wisconsin 53705, United States
Buenos Aires, C1417EYG, Argentina
Córdoba, X5016KEH, Argentina
La Rioja, 5300, Argentina
Rosario, 2000, Argentina
Tucumain, 4000, Argentina
Viedma, 8500, Argentina
Graz, 8036, Austria
Grimmenstein, 2840, Austria
Vienna, A-1140, Austria
Wels, 4600, Austria
Barretos, 14784700, Brazil
Belo Horizonte, 31110580, Brazil
Goiânia, 74140050, Brazil
Porto Alegre, 90430-090, Brazil
São Paulo, 1224010, Brazil
Edmonton, Alberta T6G 1Z2, Canada
Moncton, New Brunswick E1C 6Z8, Canada
Sainte-Foy, Quebec G1V 4G5, Canada
Grenoble, 38049, France
Lille, 59037, France
Lyon, 69373, France
Nice, 06050, France
Strasbourg, 67091, France
Toulouse, 31059, France
Vandœuvre-lès-Nancy, 54511, France
Augsburg, 86150, Germany
Bad Soden, 65812, Germany
Bielefeld, 33611, Germany
Dresden, 01307, Germany
Frankfurt, 60596, Germany
Gerlingen, 70839, Germany
Großhansdorf, 22927, Germany
Halle, 06120, Germany
Heidelberg, 69126, Germany
Immenhausen, 34376, Germany
Oldenburg, 26121, Germany
Ulm, 89081, Germany
Villingen-Schwenningen, 78050, Germany
Athens, 10676, Greece
Chania, 73300, Greece
Kifissia, 14564, Greece
Pátrai, 26500, Greece
Budapest, 1145, Hungary
Gyula, 5703, Hungary
Mátraháza, 3233, Hungary
Nyíregyháza, 4412, Hungary
Pécs, 7623, Hungary
Székesfehérvár, 8000, Hungary
Bangalore, 560099, India
Cuttack, 753007, India
Delhi, 110085, India
Jaipur, 302017, India
Kochi, 628040, India
Madurai, 625020, India
Mumbai, 400 012, India
Pune, 411001, India
Trivandrum, 695 011, India
Haifa, 31096, Israel
Jerusalem, 91120, Israel
Kfar Saba, 44281, Israel
Petah Tikva, 49100, Israel
Safed, 13110, Israel
Tel Aviv, 64239, Israel
Livorno, 57124, Italy
Monza, 20900, Italy
Novara, 28100, Italy
Padova, 35128, Italy
Palermo, 90146, Italy
Parma, 43100, Italy
Pisa, 56124, Italy
Rome, 00152, Italy
Guadalajara, 44280, Mexico
Mexico City, 14000, Mexico
's-Hertogenbosch, 5223 GZ, Netherlands
Amsterdam, 1091AC, Netherlands
Arnhem, 6815 AD, Netherlands
Harderwijk, 3844 DG, Netherlands
Zwolle, 80211 JW, Netherlands
Grafton, 1023, New Zealand
Wellington, 6002, New Zealand
Oslo, 0310, Norway
Tromsø, 9012, Norway
Gdansk, 80-219, Poland
Gdynia, 81-519, Poland
Głuchołazy, 48-340, Poland
Krakow, 31-202, Poland
Lodz, 90-242, Poland
Opole, 45-060, Poland
Otwock, 05-400, Poland
Poznan, 60-693, Poland
Bayamón, 00959, Puerto Rico
Bucharest, 022328, Romania
Cluj-Napoca, 400058, Romania
Iași, 700106, Romania
Moscow, 115478, Russia
Saint Petersburg, 197758, Russia
Stavropol, 355047, Russia
Incheon, 405-760, South Korea
Seoul, 120-752, South Korea
Suwon, 442-723, South Korea
Barcelona, 08003, Spain
Girona, 17007, Spain
Las Palmas de Gran Canaria, 35016, Spain
Madrid, 28050, Spain
Mataró, 08304, Spain
Pamplona, 31008, Spain
Pozuelo de Alarcón, 28223, Spain
Eskilstuna, 63188, Sweden
Linköping, 58185, Sweden
Lund, 22185, Sweden
Solna, 17176, Sweden
Basel, CH-4031, Switzerland
Bern, CH-3010, Switzerland
Fribourg, 1708, Switzerland
Lucerne, CH-6000, Switzerland
Zurich, CH-8091, Switzerland
Kaohsiung City, 813, Taiwan
Kuei Shan Hsiang, 33305, Taiwan
Neihu Taipei, 114, Taiwan
Niao Sung Hsiang, 833, Taiwan
Taichung, 40705, Taiwan
Taipei, 11031, Taiwan
Ankara, 06500, Turkey (Türkiye)
Istanbul, 81540, Turkey (Türkiye)
Izmir, 35340, Turkey (Türkiye)
Kayseri, 38039, Turkey (Türkiye)
Cottingham, East Yorkshire HU16 5JQ, United Kingdom
London, Greater London W6 8RF, United Kingdom
Preston, Lancashire PR2 9HT, United Kingdom
Wythenshawe, Manchester M23 9LT, United Kingdom
Scunthorpe, North Lincolnshire DN15 7BH, United Kingdom
Glasgow, Scotland G12 0YN, United Kingdom
Coventry, West Midlands CV2 2DX, United Kingdom