Non-Small Cell Lung CancerPhase 3NCT01168973
A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy
A Phase 3 study testing Ramucirumab and Docetaxel in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 231 sites in 27 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Ramucirumab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,253 participants
- Where
- 231 sitesin 27 countries
- Study dates
- Dec 2010to Aug 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- 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
Who cannot join
- 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
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- 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
- Uncontrolled arterial hypertension greater than or equal to 150 / greater than or equal to 90 millimeters of mercury (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
Trial locations and contacts
231 sites in 27 countries.
231 sites in 27 countries
United States97 sites
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Abilene, Texas, 79606
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Abington, Pennsylvania, 19001
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Albuquerque, New Mexico, 87109
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Alhambra, California, 91801
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Amarillo, Texas, 79106
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Ann Arbor, Michigan, 48109
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Ashland, Kentucky, 41101
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Athens, Georgia, 30607
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Augusta, Georgia, 30901
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Baton Rouge, Louisiana, 70809
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Beaumont, Texas, 77702
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Bedford, Texas, 76022
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Bethesda, Maryland, 20817
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Billings, Montana, 59101
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Bloomington, Indiana, 47402
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Boston, Massachusetts, 02115
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Cedar Rapids, Iowa, 52402
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Charleston, South Carolina, 29414
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Chattanooga, Tennessee, 37403
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Chevy Chase, Maryland, 20815
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Christiansburg, Virginia, 24073
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Columbia, Missouri, 65201
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Columbus, Ohio, 43219
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Dallas, Texas, 75231
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Danvers, Massachusetts, 01923
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Denver, Colorado, 80218
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Duarte, California, 91010
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Durham, North Carolina, 27704
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El Paso, Texas, 79915
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Fairfax, Virginia, 22031
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Fargo, North Dakota, 58122
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Fayetteville, Arkansas, 72703
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Fort Worth, Texas, 76104
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Framingham, Massachusetts, 01701
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Fresno, California, 93720
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Fullerton, California, 92835
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Henderson, Nevada, 89169
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Iowa City, Iowa, 52242
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Jacksonville, Florida, 32204
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Joplin, Missouri, 64804
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Kingston, Pennsylvania, 18704
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La Jolla, California, 92093
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Lacey, Washington, 98503
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Latham, New York, 12110
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Lawrenceville, Georgia, 30045
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Lebanon, New Hampshire, 03756
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Lewisville, Texas, 75067
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Long Beach, California, 90813
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Los Angeles, California, 90095
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Macon, Georgia, 31201
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Madison, Wisconsin, 53705
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McAllen, Texas, 78503
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Memphis, Tennessee, 38138
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Mesquite, Texas, 75150
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Metairie, Louisiana, 70006
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Miami, Florida, 33176
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Midland, Texas, 79701
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Minneapolis, Minnesota, 55404
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Mount Sterling, Kentucky, 40353
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New York, New York, 10021
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Newport News, Virginia, 23601
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Newton, Massachusetts, 02462
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Northridge, California, 91325
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Ocala, Florida, 34471
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Odessa, Texas, 79761
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Orlando, Florida, 32806
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Overland Park, Kansas, 66210
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Paris, Texas, 75460
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Philadelphia, Pennsylvania, 19106
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Phoenix, Arizona, 85016
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Portsmouth, New Hampshire, 03801
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Raleigh, North Carolina, 27607
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Redondo Beach, California, 90277
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Reno, Nevada, 89502
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Richmond, Virginia, 23298
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Rome, Georgia, 30165
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San Antonio, Texas, 78212
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San Antonio, Texas, 78229
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Santa Barbara, California, 93105
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Santa Monica, California, 93454
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Savannah, Georgia, 31405
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Sedona, Arizona, 86336
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Sherman, Texas, 75090
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Sioux Falls, South Dakota, 57104
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Spokane, Washington, 99216
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Springfield, Illinois, 62703
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St Louis, Missouri, 63110
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Sugar Land, Texas, 77479
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The Bronx, New York, 10467
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The Woodlands, Texas, 77380
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Tulsa, Oklahoma, 74136
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Tyler, Texas, 75702
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Waterbury, Connecticut, 06708
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Webster, Texas, 77598
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Wenatchee, Washington, 98801
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Wichita, Kansas, 67214
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Wichita Falls, Texas, 76310
Germany13 sites
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Augsburg, 86150
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Bad Soden, 65812
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Bielefeld, 33611
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Dresden, 01307
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Frankfurt, 60596
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Gerlingen, 70839
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Großhansdorf, 22927
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Halle, 06120
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Heidelberg, 69126
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Immenhausen, 34376
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Oldenburg, 26121
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Ulm, 89081
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Villingen-Schwenningen, 78050
India9 sites
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Bangalore, 560099
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Cuttack, 753007
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Delhi, 110085
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Jaipur, 302017
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Kochi, 628040
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Madurai, 625020
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Mumbai, 400 012
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Pune, 411001
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Trivandrum, 695 011
Italy8 sites
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Livorno, 57124
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Monza, 20900
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Novara, 28100
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Padova, 35128
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Palermo, 90146
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Parma, 43100
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Pisa, 56124
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Rome, 00152
Poland8 sites
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Gdansk, 80-219
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Gdynia, 81-519
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Głuchołazy, 48-340
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Krakow, 31-202
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Lodz, 90-242
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Opole, 45-060
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Otwock, 05-400
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Poznan, 60-693
United Kingdom8 sites
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Cottingham, East Yorkshire, HU16 5JQ
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Coventry, West Midlands, CV2 2DX
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Glasgow, Scotland, G12 0YN
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London, Greater London, W6 8RF
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Preston, Lancashire, PR2 9HT
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Scunthorpe, North Lincolnshire, DN15 7BH
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Wolverhampton, West Midlands, WV10 0QP
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Wythenshawe, Manchester, M23 9LT
France7 sites
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Grenoble, 38049
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Lille, 59037
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Lyon, 69373
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Nice, 06050
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Strasbourg, 67091
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Toulouse, 31059
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Vandœuvre-lès-Nancy, 54511
Spain7 sites
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Barcelona, 08003
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Girona, 17007
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Las Palmas de Gran Canaria, 35016
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Madrid, 28050
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Mataró, 08304
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Pamplona, 31008
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Pozuelo de Alarcón, 28223
Argentina6 sites
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Buenos Aires, C1417EYG
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Córdoba, X5016KEH
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La Rioja, 5300
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Rosario, 2000
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Tucumain, 4000
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Viedma, 8500
Hungary6 sites
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Budapest, 1145
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Gyula, 5703
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Mátraháza, 3233
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Nyíregyháza, 4412
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Pécs, 7623
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Székesfehérvár, 8000
Israel6 sites
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Haifa, 31096
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Jerusalem, 91120
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Kfar Saba, 44281
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Petah Tikva, 49100
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Safed, 13110
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Tel Aviv, 64239
Taiwan6 sites
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Kaohsiung City, 813
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Kuei Shan Hsiang, 33305
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Neihu Taipei, 114
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Niao Sung Hsiang, 833
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Taichung, 40705
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Taipei, 11031
Brazil5 sites
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Barretos, 14784700
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Belo Horizonte, 31110580
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Goiânia, 74140050
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Porto Alegre, 90430-090
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São Paulo, 1224010
Netherlands5 sites
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's-Hertogenbosch, 5223 GZ
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Amsterdam, 1091AC
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Arnhem, 6815 AD
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Harderwijk, 3844 DG
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Zwolle, 80211 JW
Switzerland5 sites
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Basel, CH-4031
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Bern, CH-3010
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Fribourg, 1708
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Lucerne, CH-6000
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Zurich, CH-8091
Austria4 sites
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Graz, 8036
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Grimmenstein, 2840
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Vienna, A-1140
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Wels, 4600
Greece4 sites
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Athens, 10676
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Chania, 73300
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Kifissia, 14564
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Pátrai, 26500
Sweden4 sites
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Eskilstuna, 63188
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Linköping, 58185
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Lund, 22185
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Solna, 17176
Turkey (Türkiye)4 sites
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Ankara, 06500
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Istanbul, 81540
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Izmir, 35340
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Kayseri, 38039
Canada3 sites
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Edmonton, Alberta, T6G 1Z2
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Moncton, New Brunswick, E1C 6Z8
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Sainte-Foy, Quebec, G1V 4G5
Romania3 sites
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Bucharest, 022328
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Cluj-Napoca, 400058
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Iași, 700106
Russia3 sites
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Moscow, 115478
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Saint Petersburg, 197758
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Stavropol, 355047
South Korea3 sites
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Incheon, 405-760
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Seoul, 120-752
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Suwon, 442-723
Mexico2 sites
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Guadalajara, 44280
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Mexico City, 14000
New Zealand2 sites
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Grafton, 1023
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Wellington, 6002
Norway2 sites
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Oslo, 0310
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Tromsø, 9012
Puerto Rico1 site
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Bayamón, 00959
About this study
Official title: 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Ramucirumab, Placebo (for Ramucirumab), Docetaxel
- Keywords
- second line, non small cell lung cancer, NSCLC, phase 3, ramucirumab, lung cancer, docetaxel, taxotere
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamucirumabBiological
Also called IMC 1121B, LY3009806
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
Placebo (for Ramucirumab)Drug
Administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met
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
| Study group | Role | What they receive |
|---|---|---|
| Ramucirumab + Docetaxel | Experimental | Not described Receives: Biological: Ramucirumab; Drug: Docetaxel |
| Placebo + Docetaxel | Placebo comparator | Not described Receives: Drug: Placebo (for Ramucirumab); Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization to date of death from any cause (up to 34 months)
Secondary outcomes (7)
Progression-Free Survival (PFS) Time
PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
Measured: 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)
Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)*100.
Measured: Baseline to measured PD (up to 29 months)
Percentage of Participants Achieving Disease Control (Disease Control Rate)
Participants achieved disease control if they had a best overall response of PR, CR or stable disease (SD). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN). SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control=(number of participants with CR, PR, or SD)/(number of participants assessed)*100.
Measured: Baseline to measured PD (up to 29 months)
Maximum Improvement on Lung Cancer Symptom Scale (LCSS)
The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.
Measured: 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
The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab
Measured: Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)
Number of Participants With Anti-Ramucirumab Antibodies
The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from baseline through Cycle 5 pre-infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Participants with follow-up emergent ADA were defined as participants who had any sample during 30 days post last infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer.
Measured: Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168973
- Sponsor's protocol ID
- 13852
- Other IDs
- I4T-MC-JVBA, 2010-021297-11, CP12-1027, CTRI/2011/08/001942
- Status last verified
- Sep 2019
- First submitted
- 16 Jul 2010
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35930972Garon 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.
PubMed 31958290Garon 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.
PubMed 24933332Garon 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.
PubMed 22853980
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01168973
- Acronym / sponsor ID
- 13852
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- second line, non small cell lung cancer, NSCLC, phase 3, ramucirumab, lung cancer, docetaxel, taxotere
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,253 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Posted 29 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramucirumab + Docetaxel | Experimental | Biological: Ramucirumab, Drug: Docetaxel |
| Placebo + Docetaxel | Placebo comparator | Drug: Placebo (for Ramucirumab), Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamucirumabAlso: IMC 1121B, LY300980610 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 | Biological | Ramucirumab + Docetaxel |
| Placebo (for Ramucirumab)Administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met | Drug | Placebo + Docetaxel |
| Docetaxel75 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 | Drug | Placebo + Docetaxel, Ramucirumab + Docetaxel |
Primary outcome
Overall Survival
Time frame: Randomization to date of death from any cause (up to 34 months)
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.
7 secondary outcomes
Progression-Free Survival (PFS) Time
Time frame: 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)
Time frame: Baseline to measured PD (up to 29 months)
Percentage of Participants Achieving Disease Control (Disease Control Rate)
Time frame: Baseline to measured PD (up to 29 months)
Maximum Improvement on Lung Cancer Symptom Scale (LCSS)
Time frame: 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
Time frame: Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab
Time frame: Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)
Number of Participants With Anti-Ramucirumab Antibodies
Time frame: Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35930972Rolfo 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.
- Derived from this study: PubMed 31958290Garon 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.
- Derived from this study: PubMed 24933332Garon 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.
- Derived from this study: PubMed 22853980Garon 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
231 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramucirumab and Docetaxel in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 231 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 231 sites in United States, Germany, India, Italy, Poland and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Randomization to date of death from any cause (up to 34 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01168973, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.