First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Necitumumab; Gemcitabine; Cisplatin
Intervention description: 800 milligrams (mg) Intravenously IV infusion on Days 1 and 8 of every 3 week cycle.
Continues until progressive disease, toxicity, noncompliance, or withdrawal.; 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.
Continues for a maximum of six cycles.; 75 mg/m2 IV on Day 1 of every 3 week cycle.
Continues for a maximum of six cycles.
Intervention MeSH terms: Gemcitabine; Necitumumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1093.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous; Non Small Cell Lung Cancer; First line treatment; Monoclonal; Antibodies; Epidermal Growth Factor Receptor (EGFR)

Summary:

      The research study is testing the investigational drug necitumumab (IMC-11F8) in the
      treatment of advanced non-small cell lung cancer. The aim of this study is to determine if
      necitumumab, given together with a standard chemotherapy combination consisting of cisplatin
      and gemcitabine will be more effective in improving participant disease than the standard
      chemotherapy combination alone.
    

Eligibility criteria:

        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) (participants 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 participant is surgically sterile or compliant with a highly effective
             contraceptive regimen during and for 6 months after the treatment period

          -  Female participants 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 (participants 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. Participants 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 National Cancer Institute - Common Terminology Criteria for Adverse Events
             (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 participant'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 participant with previous
             history of malignancy other than NSCLC is eligible, provided that he/she has been free
             of disease for ≥ 3 years