A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer
NCT ID: NCT01769391
Last Updated: 2019-09-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
167 participants
INTERVENTIONAL
2013-01-31
2017-07-31
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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Necitumumab +Paclitaxel+Carboplatin
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
Necitumumab
Administered IV
Paclitaxel
Administered IV
Carboplatin
Administered IV
Paclitaxel + Carboplatin
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD.
Paclitaxel
Administered IV
Carboplatin
Administered IV
Interventions
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Necitumumab
Administered IV
Paclitaxel
Administered IV
Carboplatin
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IV disease at time of study entry based on American Joint Committee on Cancer (AJCC) 7th edition
* Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors, (RECIST) Version 1.1
* Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of epidermal growth factor receptor (EGFR) protein expression by immunohistochemistry (IHC) and other biomarker assessments
Exclusion Criteria
* Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
* Previous chemotherapy for NSCLC
* Major surgery or received any investigational therapy in the 4 weeks prior to randomization
* Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
* Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)
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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Jonesboro, Arkansas, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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Colorado Springs, Colorado, United States
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Fleming Island, Florida, United States
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Fort Myers, Florida, United States
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Miami Beach, Florida, United States
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Port Saint Lucie, Florida, United States
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St. Petersburg, Florida, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Savannah, Georgia, United States
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Valdosta, Georgia, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Woodbury, Minnesota, United States
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Billings, Montana, United States
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Lincoln, Nebraska, United States
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Cherry Hill, New Jersey, United States
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Hackensack, New Jersey, United States
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Latham, New York, United States
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Cincinnati, Ohio, United States
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Eugene, Oregon, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Chattanooga, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Fort Worth, Texas, United States
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The Woodlands, Texas, United States
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Richmond, Virginia, United States
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Großhansdorf, , Germany
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Heidelberg, , Germany
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Immenhausen, , Germany
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Münster, , Germany
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Chihuahua City, , Mexico
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León, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Głuchołazy, , Poland
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Olsztyn, , Poland
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Otwock, , Poland
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Poznan, , Poland
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Radom, , Poland
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Warsaw, , Poland
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Saint Petersburg, , Russia
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Incheon, , South Korea
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Seoul, , South Korea
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Ulsan, , South Korea
Countries
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Other Identifiers
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I4X-MC-JFCL
Identifier Type: OTHER
Identifier Source: secondary_id
2012-003214-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14790
Identifier Type: -
Identifier Source: org_study_id
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