Lung Cancer Clinical Trial

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)

Summary

The purpose of this study is to determine if participants with Stage IV NSCLC have a better outcome when treated with IMC-1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin alone.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Confirmed NSCLC
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:

Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

280

Study ID:

NCT01160744

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 53 Locations for this study

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Scottsdale Arizona, 85258, United States
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Tucson Arizona, 85704, United States
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Corona California, 92879, United States
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Fountain Valley California, 92708, United States
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Riverside California, 92501, United States
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Aurora Colorado, 80045, United States
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Fort Myers Florida, 33916, United States
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Miami Florida, 33176, United States
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Chicago Illinois, 60612, United States
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Peoria Illinois, 61615, United States
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Louisville Kentucky, 40202, United States
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Alexandria Louisiana, 71301, United States
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Minneapolis Minnesota, 55404, United States
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Columbia Missouri, 65201, United States
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Lincoln Nebraska, 68506, United States
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Neptune New Jersey, 07754, United States
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Bronx New York, 10467, United States
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Latham New York, 12110, United States
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Langhorne Pennsylvania, 19047, United States
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Hilton Head Island South Carolina, 29926, United States
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Nashville Tennessee, 37203, United States
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Bedford Texas, 76022, United States
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Dallas Texas, 75231, United States
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El Paso Texas, 79915, United States
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Fort Worth Texas, 76104, United States
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Kerrville Texas, 78028, United States
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Longview Texas, 75601, United States
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McAllen Texas, 78503, United States
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Midland Texas, 79701, United States
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Paris Texas, 75460, United States
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San Antonio Texas, 78229, United States
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The Woodlands Texas, 77380, United States
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Tyler Texas, 75702, United States
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Waco Texas, 76712, United States
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Christiansburg Virginia, 24073, United States
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Fairfax Virginia, 22031, United States
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Seattle Washington, 98133, United States
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Spokane Valley Washington, 99216, United States
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Gent , 9000, Belgium
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Toronto Ontario, M4N 3, Canada
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Montreal Quebec, H2L 4, Canada
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Berlin , 14165, Germany
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Erlangen , 91054, Germany
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Großhansdorf , 22927, Germany
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Hemer , 58675, Germany
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Karlsruhe , 76137, Germany
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Regensburg , 93053, Germany
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Ulm , 89081, Germany
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Gdansk , 80-95, Poland
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Olsztyn , 10-35, Poland
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Warsaw , 02-78, Poland
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Bangor Gwynedo, LL57 , United Kingdom
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Nottingham Nottinghamshire, NG5 1, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

280

Study ID:

NCT01160744

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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