A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ramucirumab; Paclitaxel; Carboplatin
Intervention description: 10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, on Day 1 of each 21-day cycle.; 200 milligrams per meter squared (mg/m^2), administered intravenously (IV) following the ramucirumab infusion, on day 1 of each 21-day cycle, for up to six cycles.; Administered after paclitaxel, as an intravenous infusion (IV), over 30 minutes on day 1 of each 21-day cycle, for up to six cycles. The dose to be administered is calculated based on the participant's actual body weight at time of treatment and the area under the curve (AUC) dosing. The target AUC for carboplatin treatment is AUC=6.
Intervention MeSH terms: Paclitaxel; Carboplatin; Ramucirumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non Small Cell Lung Cancer; Lung; NSCLC

Summary:

      The purpose of this study is to evaluate the progression-free survival (PFS) rate at 6 months
      of ramucirumab administered in combination with paclitaxel and carboplatin as first-line
      therapy for Stage IIIB or IV non-small cell lung cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed NSCLC

          -  Advanced NSCLC

          -  Measurable disease (as defined by Response Evaluation Criteria in Solid Tumors [RECIST
             1.0])

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status is ≤ 1

          -  Age ≥ 18 years

          -  Adequate hematologic function = an absolute neutrophil count (ANC) ≥ 1500/μL,
             hemoglobin ≥ 9 g/dL, and a platelet count ≥ 100,000/microliter (μL)

          -  Adequate hepatic function = a total bilirubin ≤ 1.5 mg/dL transaminases and alkaline
             phosphatase ≤ 5 x the upper limit of normal (ULN)

          -  Adequate renal function serum creatinine ≤ 1.5 x ULN or calculated creatinine
             clearance (CrCl) > 60 mL/minute, and urine dipstick for protein < 1+ (ie, either 0 or
             trace)

          -  Adequate coagulation function, INR ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5
             seconds above ULN

          -  Adequate contraception

          -  Signed informed consent

        Exclusion Criteria:

          -  Untreated CNS metastases

          -  Prior bevacizumab therapy

          -  Radiologically documented evidence of major blood vessel invasion or encasement by
             cancer

          -  Prior systemic chemotherapy for Stage IIIB/IV NSCLC

          -  Prior systemic chemotherapy or radiation therapy for Stage I-IIIA NSCLC < 1 year prior

          -  Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of
             the cervix

          -  Concurrent treatment with other anticancer therapy, including other chemotherapy,
             immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy

          -  Ongoing or active infection, symptomatic congestive heart failure, unstable angina
             pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
             limit compliance with study requirements

          -  Uncontrolled thrombotic or hemorrhagic disorders

          -  Poorly-controlled hypertension

          -  Chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of
             platelet function

          -  History of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon)

          -  Serious non-healing wound, ulcer, or bone fracture

          -  Undergone major surgery or subcutaneous venous access device placement. Post-operative
             bleeding complications or wound complications from a surgical procedures performed in
             the last 2 months

          -  Elective or a planned major surgery to be performed during the course of the trial

          -  Peripheral neuropathy ≥ Grade 2 (National Cancer Institute Common Toxicity Criteria
             for Adverse Events, Version 3.0 [NCI-CTCAE v 3.0])

          -  If female, is pregnant or lactating

          -  Radiographic evidence of intratumor cavitation

          -  Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry