Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Squamous Non-Small Cell Lung Cancer Disease (NSCLC)
Clinical Stage IV NSCLC
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 systematic chemotherapy, targeted therapy, surgery and chest radiotherapy
Ha resolution to Grade less than or equal to (≤) 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0, of all clinically significant toxic effects of prior therapy for other than NSCLC
Adequate-organ function defined as:
Total bilirubin ≤1.5 x the upper limit of normal value (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
Serum creatinine ≤ 1.2 x ULN or calculated creatinine clearance (CrCL)\>50 milliliter per minute (mL/min) (per the Cockcroft Gault formula or equivalent and/or 24-hour urine collection)
Absolute neutrophil count (ANC) greater than or equal to ≥1.5 x 10\^3/μL(microliter)
Hemoglobin ≥10.0 g/dL(gram per deciliter)
Platelets ≥100 x 10\^3/μL
At least 20 years of age
Estimated life expectancy of at least 12 weeks
A formalin-fixed, paraffin-embedded tumor tissue block or a minimum of 5 unstained slides of tumor sample prior to randomization for the evaluation of epidermal growth factor receptor (EGFR) protein expression (IHC).
If women: 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 men: surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period.
Has provided signed informed consent
You may not be if
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
