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

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