Bortezomib (Velcade) + Pemetrexed (Alimta) in Advanced NSCLC

Inclusion Criteria:

• Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC who have received one prior platinum-based chemotherapy regimen.
• One prior treatment with any biologically targeted agent is acceptable
• Stable, previously treated, brain metastases are allowed if clinically stable without steroid treatment for 10 days.
• ECOG performance status of 0 or 1.
• Measurable and/or evaluable indicator lesion(s).
• Adequate hematologic, renal and hepatic function
• Patient is of a legally consenting age
• Patient has a life-expectancy >2 months.
• Voluntary written informed consent before performance of any study-related procedure
• Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.
• Male patient agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:

• Prior treatment with pemetrexed (Alimta) or Bortezomib (Velcade).
• Patient was treated for another cancer within 3 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
• Peripheral neuropathy NCI grade > 2.
• Symptomatic or uncontrolled brain metastasis.
• Radiation therapy to major bone marrow (> 10% of bone marrow) areas or to target lesions within 30 days prior to study entry.
• Patient has received other investigational drugs with 14 days before enrollment.
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Any systemic therapy within 21 days prior to study entry.
• Patient known to be human immunodeficiency virus (HIV)-positive.
• Patient had a significant cardiac event within 6 months of enrollment
• History of arrhythmia
• Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
• QT prolongation with other medications that required discontinuation of that medication.
• Presence of left bundle branch block (LBBB).
• QTc ≥480 msec or greater on screening ECG.
• Patient has hypersensitivity to bortezomib, boron or mannitol.
• Female patient is pregnant or breast-feeding.