Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)
Condition: Lung Cancer; Chemotherapy-Induced Thrombocytopenia; Non-Small Cell Lung Cancer; Cancer; Lung Neoplasms; Oncology; Solid Tumors; Thrombocytopenia
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Thrombocytopenia
Intervention: Romiplostim; Placebo; Gemcitabine; Carboplatin; Cisplatin
Intervention description: Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.; Placebo subcutaneous injection.; Intravenous infusion; Intravenous infusion; Intravenous infusion
Intervention MeSH terms: Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Non-Small Cell Lung Cancer; Chemotherapy Induced Thrombocytopenia; CIT; NSCLC; Stage IIIB NSCLC; Stage IV NSCLC; Gemcitabine; Carboplatin; Cisplatin

Summary:

      The purpose of this study is to identify an effective, well tolerated dose and schedule of
      romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia
      (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed locally advanced or metastatic stage IIIB or
             stage IV NSCLC receiving 21-day cycles of gemcitabine/carboplatin or
             gemcitabine/cisplatin

          -  Life expectancy ≥ 12 weeks at the time of screening

          -  Thrombocytopenia as evidenced by a platelet count ≤ 50 x 10^9/L during the qualifying
             cycle of chemotherapy, OR platelet count < 100 x 10^9/L on Day 22 of the qualifying
             cycle (for eligibility inclusion: ability to receive the same dose of chemotherapy on
             study), this criteria ensures that the patient must be dose delayed for platelet
             recovery

          -  Ability to receive the same dose and schedule of chemotherapy during the first
             on-study treatment cycle as was given in the qualifying cycle (except Day 8
             gemcitabine)

          -  Absolute neutrophil count (ANC) ≥ 1,000/µL, hemoglobin ≥ 9.5 g/dL, and platelet count
             ≥ 100 x 10 ^9/L on Day 1 of the first on study chemotherapy treatment cycle

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of
             screening

          -  Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase
             (ALT) < 3.0 x upper limit of normal (ULN) (except for patients with a confirmed
             diagnosis of Gilbert's Syndrome)

          -  Adequate renal function; serum creatinine < 1.5 x ULN

        Exclusion Criteria:

          -  Receipt of > 1 prior systemic chemotherapy regimen

          -  Sepsis, disseminated coagulation or any other condition (i.e. immune [idiopathic]
             thrombocytopenic purpura [ITP], thrombotic thrombocytopenic purpura [TTP], hemolytic
             uremic syndrome [HUS]) that may exacerbate thrombocytopenia

          -  History of unstable angina, congestive heart failure, uncontrolled hypertension
             (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year of
             screening ) myocardial infarction

          -  History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1
             year of screening

          -  History of pulmonary embolism or other venous thrombosis within 1 year of screening
             (except for catheter-related clots)

          -  Use of any nitrosourea or mitomycin-C within 6 weeks of screening

          -  Have received any thrombopoietic growth factor or related substance

          -  Have received granulocyte macrophage colony stimulating factor (GM-CSF) within the
             last 4 weeks prior to screening

          -  Have received any experimental therapy within 4 weeks prior to screening

          -  Have ever received a bone marrow or peripheral blood stem cell infusion (within 1 year
             of screening)

          -  Known hypersensitivity to any recombinant E. coli-derived product.