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)

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)