A Study of Necitumumab in the First-Line Treatment of Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Exclusion Criteria

• •Has enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
• •Participant has undergone major surgery within 28 days prior to enrollment or have planned major surgery, subcutaneous venous access device placement within 7 days prior to enrollment Phase 1b) or randomization (Phase 2).
• •Has undergone any prior radiation therapy, except for Gamma Knife radiation and palliative radiation treatment at least 14 days have elapsed from last radiation treatment prior to enrollment (Phase 1b) or randomization (Phase 2)
• •Has brain metastases that are symptomatic or require surgery, medication and radiotherapy except for stereotactic irradiation
• •Has superior vena cava syndrome
• •Has clinically relevant coronary artery disease or uncontrolled congestive - heart failure
• •Participant has uncontrolled hypertension defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg despite standard medical management.
• •Has diabetes requiring insulin
• •Has an angina or has experienced myocardial infarction within 6 months prior to enrollment (Phase 1b) or randomization (Phase 2)
• •Has an Acquired Immunodeficiency Syndrome (AIDS)-related illness or have evidence of or test positive test results for human immunodeficiency virus (HIV)
• •Has evidence of or test positive test results for hepatitis B, or hepatitis C virus antibodies
• •Has a known allergy and history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or any other contraindication to one of the administered treatments
• •Has significant third-space fluid retention requiring drainage
• •Has history of interstitial pneumonitis
• •Has an ongoing or active infection
• •Has a history of significant neurological or psychiatric disorders
• •Has a Grade 2 peripheral neuropathy
• •Pregnant (confirmed within 7 days prior to enrollment \[Phase 1b\] or randomization \[Phase 2\]), or breastfeeding
• •Has known history of drug abuse
• •Assessed as inadequate for the study by the investigator or sub investigator