An Open-Label, Multicenter, Phase 1b/2 Study to Evaluate Necitumumab in Combination With Gemcitabine and Cisplatin in the First-Line Treatment of Patients With Advanced (Stage IV) Squamous Non-Small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
- Squamous Non-Small Cell Lung Cancer Disease
- Clinical Stage IV
- Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in
Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- No prior chemotherapy regimen, surgery and chest radiotherapy
- Adequate organ function
- Estimated life expectancy of at least 12 weeks
Exclusion Criteria:
- 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
- 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
- Has brain metastases that are symptomatic or require surgery, medication and
radiotherapy except Gamma Knife
- Has superior vena cava syndrome
- Has clinically relevant coronary artery disease or uncontrolled congestive - heart
failure
- Has uncontrolled hypertension
- Has diabetes requiring insulin
- Has an angina or has experienced myocardial infarction within 6 months prior to
enrollment
- Has an Acquired Immunodeficiency Syndrome (AIDS)-related illness
- 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
- Has significant third-space fluid retention
- 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