A Study of Pemetrexed and Carboplatin/Cisplatin or Gemcitabine and Carboplatin/Cisplatin With or Without IMC-1121B in Participants Previously Untreated With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT01160744
Last Updated: 2019-09-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
280 participants
INTERVENTIONAL
2010-09-30
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IMC-1121B + Pemetrexed + Carboplatin (AUC 6) or Cisplatin
IMC-1121B + Pemetrexed + Carboplatin \[Area Under the Concentration Time Curve 6 (AUC 6)\] or Cisplatin
IMC-1121B (ramucirumab)
10 milligrams/kilogram (mg/kg) once every 3 weeks beginning Day 1, Cycle 1
Pemetrexed
500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle
Carboplatin (AUC 6)
Day 1 of every 21-day cycle
Cisplatin
75 mg/m² intravenous (IV) on Day 1 of each 21-day cycle
Pemetrexed + Carboplatin (AUC 6) or Cisplatin
Pemetrexed + Carboplatin (AUC 6) or Cisplatin
Pemetrexed
500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle
Carboplatin (AUC 6)
Day 1 of every 21-day cycle
Cisplatin
75 mg/m² intravenous (IV) on Day 1 of each 21-day cycle
IMC-1121B + Gemcitabine + Carboplatin (AUC 5) or Cisplatin
IMC-1121B + Gemcitabine + Carboplatin \[Area Under the Concentration Time Curve 5 (AUC 5)\] or Cisplatin
IMC-1121B (ramucirumab)
10 milligrams/kilogram (mg/kg) once every 3 weeks beginning Day 1, Cycle 1
Cisplatin
75 mg/m² intravenous (IV) on Day 1 of each 21-day cycle
Gemcitabine
1000 mg/m² on Days 1 and 8 of every 21-day cycle
Carboplatin (AUC 5)
Day 1 of every 21-day cycle
Gemcitabine + Carboplatin (AUC 5) or Cisplatin
Gemcitabine + Carboplatin (AUC 5) or Cisplatin
Cisplatin
75 mg/m² intravenous (IV) on Day 1 of each 21-day cycle
Gemcitabine
1000 mg/m² on Days 1 and 8 of every 21-day cycle
Carboplatin (AUC 5)
Day 1 of every 21-day cycle
Interventions
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IMC-1121B (ramucirumab)
10 milligrams/kilogram (mg/kg) once every 3 weeks beginning Day 1, Cycle 1
Pemetrexed
500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle
Carboplatin (AUC 6)
Day 1 of every 21-day cycle
Cisplatin
75 mg/m² intravenous (IV) on Day 1 of each 21-day cycle
Gemcitabine
1000 mg/m² on Days 1 and 8 of every 21-day cycle
Carboplatin (AUC 5)
Day 1 of every 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IV disease at the time of study entry
* Measurable disease at the time of study entry
* Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (except alopecia)
* Adequate hematologic function, hepatic function, renal function and coagulation function
* If sexually active, must be post-menopausal, surgically sterile, or using effective contraception; and agrees to use adequate contraception during the study period and for up to 6 months after the last dose of study medication
* Female participants of childbearing potential must have a negative serum pregnancy test
Exclusion Criteria
* Tumor wholly or partially contains small cell lung cancer
* Untreated central nervous system (CNS) metastases, eligible if they are clinically stable with regard to neurologic function, off all steroids after cranial irradiation at least 2 weeks prior or after surgical resection performed at least 4 weeks prior to randomization
* Concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. A participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years
* Received prior therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR)
* Receiving concurrent treatment with other anticancer therapy
* Has received previous chemotherapy for Stage IV NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
* Has radiologically documented evidence of major blood vessel invasion or encasement by cancer
* Has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions)
* Ongoing or active infection
* History of significant neurological or psychiatric disorders
* Experienced clinically relevant coronary artery disease, myocardial infarction within 6 months prior to randomization, uncontrolled congestive heart failure, or symptomatic poorly controlled arrhythmia
* Poorly-controlled hypertension
* Experienced any serious Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry
* Receiving chronic daily treatment with aspirin (\> 325 mg/day) or other known inhibitors of platelet function
* Serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
* Major surgery within 28 days prior the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to randomization
* Elective or a planned major surgery
* Pregnant or lactating
* Any other serious uncontrolled medical disorders or psychological conditions
* Allergy / history of hypersensitivity reaction to any of the treatment components
* History of drug abuse
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Corona, California, United States
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Fountain Valley, California, United States
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Riverside, California, United States
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Aurora, Colorado, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Louisville, Kentucky, United States
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Alexandria, Louisiana, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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Lincoln, Nebraska, United States
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Neptune City, New Jersey, United States
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Latham, New York, United States
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The Bronx, New York, United States
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Langhorne, Pennsylvania, United States
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Hilton Head Island, South Carolina, United States
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Nashville, Tennessee, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Kerrville, Texas, United States
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Longview, Texas, United States
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McAllen, Texas, United States
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Midland, Texas, United States
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Paris, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
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Tyler, Texas, United States
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Waco, Texas, United States
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Christiansburg, Virginia, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Spokane Valley, Washington, United States
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Ghent, , Belgium
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Berlin, , Germany
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Erlangen, , Germany
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Großhansdorf, , Germany
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Hemer, , Germany
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Karlsruhe, , Germany
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Regensburg, , Germany
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Ulm, , Germany
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Gdansk, , Poland
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Olsztyn, , Poland
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Warsaw, , Poland
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Bangor, Gwynedo, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
Countries
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References
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Doebele RC, Spigel D, Tehfe M, Thomas S, Reck M, Verma S, Eakle J, Bustin F, Goldschmidt J Jr, Cao D, Alexandris E, Yurasov S, Camidge DR, Bonomi P. Phase 2, randomized, open-label study of ramucirumab in combination with first-line pemetrexed and platinum chemotherapy in patients with nonsquamous, advanced/metastatic non-small cell lung cancer. Cancer. 2015 Mar 15;121(6):883-92. doi: 10.1002/cncr.29132. Epub 2014 Nov 6.
Other Identifiers
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I4T-IE-JVBL
Identifier Type: OTHER
Identifier Source: secondary_id
CP12-0917
Identifier Type: OTHER
Identifier Source: secondary_id
2009-016784-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13916
Identifier Type: -
Identifier Source: org_study_id
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