A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Gemcitabine; Cisplatin; IMC-A12 (cixutumumab); Cetuximab; IMC-A12 (cixutumumab); Cetuximab; Carboplatin
Intervention description: 1000 milligrams per square meter (mg/m^2) on Days 1 and 8 of each cycle
[First 6 cycles (18 weeks)]; 75 mg/m^2 on Day 1 of each cycle
[First 6 cycles (18 weeks)]; 6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle)
[First 6 cycles (18 weeks)]; 400 mg/m^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m^2 once per week thereafter
[First 6 cycles (18 weeks)]; 10 mg/kg IV infusion, administered once every 2 weeks
(Maintenance therapy); 500 mg/m^2 IV infusion, administered once every 2 weeks
(Maintenance therapy); Area under the curve (AUC) = 5, Day 1 of each cycle
[First 6 cycles (18 weeks)]
*Carboplatin will be replaced by Cisplatin
Intervention MeSH terms: Carboplatin; Gemcitabine; Cetuximab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tumors; Antibodies, Monoclonal; Stage IIIb Metastatic Non-Small Cell Lung Cancer; Stage IV Metastatic Non-Small Cell Lung Cancer

Summary:

      The purpose of this study is to determine the number of participants whose cancer shrinks or
      disappears after treatment on the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has histologically or cytologically confirmed, Stage IIIb - IV NSCLC

          -  Has metastatic disease

          -  Has a tumor measurable according to Response Evaluation Criteria in Solid Tumors
             (RECIST)

          -  Has adequate hematologic function

          -  Has adequate hepatic function

          -  Has adequate renal function

          -  Women of childbearing potential must agree to use adequate contraception (hormonal or
             barrier method of birth control; abstinence) prior to study entry and for the duration
             of study participation

        Exclusion Criteria:

          -  Has uncontrolled brain metastases

          -  Has leptomeningeal disease

          -  Has received previous chemotherapy for NSCLC (participants who have received adjuvant
             chemotherapy are eligible if the last administration of the prior adjuvant regimen
             occurred at least 6 months prior to randomization)

          -  Receiving any other investigational agent(s)

          -  Has a history of treatment with other agents targeting the insulin-like growth factor
             (IGF) or the epidermal growth factor (EGF) receptor

          -  Has a known allergy / history of hypersensitivity reaction to any of the treatment
             components

          -  Has poorly controlled diabetes mellitus. Participants with a history of diabetes
             mellitus are allowed to participate, provided that their blood glucose is within
             normal range [fasting glucose <160 milligrams per deciliter (mg/dL) or below the upper
             limit of normal (ULN) and hemoglobin A1C≤ 7%] and that they are on a stable dietary or
             therapeutic regimen for this condition

          -  Has an uncontrolled intercurrent illness

          -  Pregnant or lactating

          -  Has a history of another primary cancer, with the exception of: a) curatively resected
             nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c)
             other primary solid tumor treated with curative intent and no known active disease
             present and no treatment administered during the last 3 years

          -  Has superior vena cava syndrome contraindicating hydration

          -  Has current clinically-relevant coronary artery disease (New York Heart Association
             III or IV) or uncontrolled congestive heart failure

          -  Has any National Cancer Institute Common Toxicity Criteria for Adverse Events
             (NCI-CTCAE) Version (v) 3.0 Grade ≥2 peripheral neuropathy

          -  Has significant third space fluid retention, requiring repeated drainage