First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Cisplatin; Necitumumab
Intervention description: 500 milligram per square meter (mg/m2) administered Intravenously (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles; 75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles; 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.
Intervention MeSH terms: Pemetrexed; Necitumumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 633.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nonsquamous; 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 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
      pemetrexed will be more effective in improving participant disease than the standard
      chemotherapy combination alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has histologically or cytologically confirmed nonsquamous (adenocarcinoma/large cell
             or other) non small cell lung cancer

          -  Has Stage IV disease at the time of study entry

          -  Measurable or nonmeasurable disease (as defined by the Response Evaluation Criteria in
             Solid Tumors RECIST 1.0) at the time of study entry (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 an Eastern Cooperative Oncology Group performance status score of 0-2

          -  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 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 participants 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

        Exclusion Criteria:

          -  Has squamous non small cell lung cancer

          -  Has received prior anticancer therapy with monoclonal antibodies, signal transduction
             inhibitors, or any therapies targeting the Epidermal Growth Factor Hormone (EGFR),
             vascular endothelial growth factor (VEGF), or VEGF receptor

          -  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)

          -  Undergone major surgery or received any investigational therapy in the 4 weeks prior
             to randomization

          -  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, potentially precluding protocol compliance

          -  Has 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 The participant has a known allergy /
             history of hypersensitivity reaction to any of the treatment components, including any
             ingredient used in the formulation of 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