A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

- Has histologically or cytologically confirmed squamous NSCLC

- Has Stage IV disease at the time of study entry

- Measurable or nonmeasurable disease at the time of study entry as defined by the
Response Evaluation Criteria in Solid Tumors (RECIST 1.0) (patients with only truly
nonmeasurable disease are not eligible)

- Has resolution to Grade ≤ 1 of all clinically significant toxic effects of prior
chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of
alopecia)

- Has adequate hepatic function

- Has adequate renal function

- Has adequate hematologic function

- If female, is surgically sterile, postmenopausal, or compliant with a highly
effective contraceptive method (failure rate < 1%) during and for 6 months after the
treatment period (oral hormonal contraception alone is not considered highly
effective and must be used in combination with a barrier method)

- If male, the patient is surgically sterile or compliant with a highly effective
contraceptive regimen during and for 6 months after the treatment period

- Female patients of childbearing potential must have a negative serum pregnancy test
within 7 days prior to randomization

- Has archived tumor tissue available for analysis of EGFR and KRAS mutation status (by
PCR) and EGFR gene copy number (by FISH); minimum of four slides, paraffin-embedded
tissue, required

Exclusion Criteria:

- Has nonsquamous NSCLC (adenocarcinoma/large cell or other)

- Has received prior anticancer therapy with monoclonal antibodies, signal transduction
inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor
(VEGF), or VEGF receptor

- Has received previous chemotherapy for advanced NSCLC (patients who have received
adjuvant chemotherapy are eligible if the last administration of the prior adjuvant
regimen occurred at least 1 year prior to randomization)

- Has undergone major surgery or received any investigational therapy in the 4 weeks
prior to randomization

- Has undergone chest irradiation within 12 weeks prior to randomization (except
palliative irradiation of bone lesions, which is allowed)

- Has brain metastases that are symptomatic or require ongoing treatment with steroids
or anticonvulsants. Patients who have undergone previous radiotherapy for brain
metastases, who are now nonsymptomatic and no longer require treatment with steroids
or anticonvulsants, are eligible

- Has superior vena cava syndrome contraindicating hydration

- Has current clinically-relevant coronary artery disease or uncontrolled congestive
heart failure

- Has experienced myocardial infarction within 6 months prior to randomization

- Has an ongoing or active infection (requiring antibiotics), including active
tuberculosis or known infection with the human immunodeficiency virus

- Has a history of significant neurological or psychiatric disorders, including
dementia, seizures, or bipolar disorder

- Has any NCI-CTCAE Version 3.0 Grade ≥ 2 peripheral neuropathy

- Has significant third space fluid retention, requiring repeated drainage

- Has any other serious uncontrolled medical disorders or psychological conditions that
would, in the opinion of the investigator, limit the patient's ability to complete
the study or sign an informed consent document

- Has a known allergy / history of hypersensitivity reaction to any of the treatment
components, including any ingredient used in the formulation of necitumumab
(IMC-11F8), or any other contraindication to one of the administered treatments

- Is pregnant or breastfeeding

- Has a known history of drug abuse

- Has a concurrent active malignancy other than adequately-treated basal cell carcinoma
of the skin or preinvasive carcinoma of the cervix. A patient with previous history
of malignancy other than NSCLC is eligible, provided that he/she has been free of
disease for ≥ 3 years