A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer

An Open Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as a Second-Line Therapy for Patients With KRAS Mutation Positive or Squamous Cell Non-Small Cell Lung Cancer

BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.

Inclusion Criteria:

• Males or females at least 18 years of age
• Diagnosis of NSCLC with locally advanced or metastatic disease
• Positive for KRAS mutation or Squamous cell histology
• Previously treated with one platinum-based chemotherapy
• Disease status must be that of measurable and/or evaluable disease
• Performance status of 0 to 1 on the ECOG Scale
• Prior chemotherapy completed at least 3 weeks prior to study enrollment
• Prior radiation therapy allowed to < 25% of the bone marrow
• Patient compliance and geographic proximity that allow adequate follow-up
• Adequate organ function
• Patients with reproductive potential must use contraceptive methods
• Signed informed consent from patient

Exclusion Criteria:

• Active infection
• Pregnancy or planning to become pregnant
• Breast feeding
• Serious concomitant systemic disorders
• Second primary malignancy
• Patients who are symptomatic from brain metastasis
• Presence of detectable (by physical exam) third-space fluid collections
• More than 1 prior cytotoxic chemotherapy regimen for advanced disease
• Prior treatment with docetaxel
• History of severe hypersensitivity reaction to polysorbate 80
• Peripheral neuropathy at study entry
• Patients known to be HIV positive
• Patients known to be seropositive for hepatitis C hepatitis B
• Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia