A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:March 2013
End Date:September 2016
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to see how participants with late stage lung cancer do on
gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the
drugs are in combination and to see how long the medicine stays in the body. The study will
last approximately 2 years.


Inclusion Criteria:

- Histologically or cytologically confirmed squamous Non-small Cell Lung Cancer (NSCLC)

- Stage IV disease at time of study entry based on American Joint Committee on Cancer
7th edition

- Measurable disease at time of study entry as defined by Response Evaluation Criteria
in Solid Tumors (RECIST), Version 1.1

Exclusion Criteria:

- Nonsquamous NSCLC

- Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors,
or any therapies targeting the epidermal growth factor receptor (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 study
enrollment

- 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
3
sites
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Birmingham, AL
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Deerfield Beach, FL
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Farmington Hills, Michigan 48334
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Farmington Hills, MI
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