Health Condition 1: null- Advanced Nonâ??Small Cell Lung Cancer
Conditions
Interventions
Intervention1: BIO 11006 and SOC (Pemetrexed and Carboplatin): Bio 11006 will be administered at a dose of 125mg twice daily. Pemetrexed 500 mg/m2 and carboplatin AUC6 as standard of care will be admi
Sponsors
Biomarck Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be the progression free survival PFS in patients who have received BIO 11006 plus SOC compared to those who have received SOC alone. The secondary efficacy endpoints will include response rate per Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, OS,weight maintenance,and breathing via modified Borg scale.Timepoint: Cycle 1 Day 1, 3 months after 4 cycles, follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints will include the frequency, type, severity, and duration of TEAEs. Sources of TEAEs may include spontaneous patient reports, results of physical examinations, and clinical laboratory measurementsTimepoint: Every 3 weeks. | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed