A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:January 2013
End Date:July 2017

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A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy
of paclitaxel and carboplatin is more effective to treat cancer than the standard
chemotherapy of paclitaxel and carboplatin alone.


Inclusion Criteria:

- Histologically or cytologically confirmed squamous NSCLC

- 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:

- Nonsquamous NSCLC

- 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)
We found this trial at
34
sites
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Chattanooga, TN
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Billings, MT
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Charleston, South Carolina 29412
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Charleston, SC
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Cherry Hill, NJ
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Cincinnati, OH
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Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Columbia, SC
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Eugene, OR
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Fleming Island, FL
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Fort Myers, FL
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Fort Worth, TX
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Großhansdorf,
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Hackensack, NJ
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Jonesboro, AR
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Kalamazoo, MI
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Lansing, MI
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Latham, NY
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Lincoln, NE
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Los Angeles, CA
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Louisville, KY
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Macon, GA
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Marietta, GA
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Memphis, TN
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Miami Beach, FL
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Nashville, TN
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Port Saint Lucie, FL
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Richmond, VA
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Sacramento, CA
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Saint Petersburg, Florida 33713
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Saint Petersburg, FL
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Savannah, GA
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The Woodlands, TX
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Valdosta, GA
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Wichita, KS
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from
Woodbury, MN
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