Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celgene
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
Male or non-pregnant and non-lactating female, and equal or greater than age 18
* If a female patient is of child-bearing potential, as evidence by regular menstrual periods, she must have a negative serum pregnancy test (beta human chorionic gonadotropin \[βhCG\]) documented within 72 hours of the first administration of study drug
* If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator
No other current active malignancy
Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion)
Patients must have received no prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study
Patient has the following blood counts at baseline:
* Absolute neutrophil count (ANC) greater than or equal to 1.5x10\^9/L
* Platelets greater than or equal to 100x10\^9/L
* Hemoglobin (Hgb) greater than or equal to 9 g/dL
Patient has the following blood chemistry levels at baseline:
* Aspartate aminotransferase (SGOT), alanine aminotransferase (SGPT) less than or equal to 2.5 x upper limit of normal range (ULN) or less than or equal to 5.0 x ULN if liver metastases;
* Total bilirubin less than or equal to ULN
* Creatinine less than or equal to 1.5 mg/dL
Expected survival of greater than 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities
You may not be if
Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable and off therapy for greater than or equal to 1 month
The only evidence of disease is non-measurable
Patient has pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events \[CTCAE\] Version 3).
Patient received radiotherapy in the last 4 weeks, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed
Patient has a clinically significant concurrent illness
Patient has received treatment with any investigational drug within the previous 4 weeks
Patient has a history of allergy or hypersensitivity to any of the study drugs
Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug
Patient is enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices.
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