A Randomized Study of the Safety and Efficacy of BIO-11006 in the Treatment of Advanced Nonâ??Small Cell Lung Cancer in Patients who Are not Candidates for Curative Surgery and/or Radiation and who Are Receiving Pemetrexed and Carboplatin.

Biomarck Pharmaceuticals0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients with histologically proven non-squamous NSCLC (relapsed and newly diagnosed patients are allowed on study).
•2.Male or female patients at least 18 years of age. Female patients must be of non-childbearing potential (i.e., surgically sterile or post-menopausal [defined as at least 1 year of non-therapy induced amenorrhea]) or be willing to use highly effective forms of contraception (i.e., failure rate of less than 1% per year). Female patients of childbearing potential must have a negative pregnancy test prior to the first dose of study drug.
•3.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
•4.Has the ability to understand and comply with the requirements of the study (as determined by the Investigator).
•5.Provided written informed consent and authorization for use and disclosure of protected health information.
•6.Measurable disease per RECIST Version 1.1.

•1.Pregnant or breastfeeding.
•2.Prisoner.
•3.Patients with squamous disease.
•4.Patients with NSCLC who are candidates for curative surgery and/or radiation therapy.
•5.Patients with any contraindication to standard of care pemetrexed and carboplatin.
•6.Patients with a baseline absolute neutrophil count (ANC) less than 2000 cells/mm3 or platelet count less than 100,000 cells/mm3 and hemoglobin less than 10 g/dL (OK to reach via transfusion)
•7.Patients with creatinine clearance (CrCl) less than 45 mL/min
•8.Bilirubin greater than 2 Ã? the upper limit of normal
•9.Known hypersensitivity to any component of BIO-11006, pemetrexed, or carboplatin.
•10.Treatment with another investigational agent within 12 weeks of enrollment.
•11.Known history of human immunodeficiency virus, hepatitis B, hepatitis C or tuberculosis.
•12.Current pneumonia or idiopathic pulmonary fibrosis.
•13.Patients taking drugs primarily metabolized by cytochrome P450 isoenzymes.
•14.Severe infections (per P.I. opinion) within 3 months prior to enrollment, including hospitalization for infection.
•15.Organ transplant or bone marrow transplant recipient.
•16.Patients with CNS metastases

发起方

Biomarck Pharmaceuticals