A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis

Inclusion Criteria:

- Age greater than or equal to 18 years

- Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell
carcinoma).

- Unresectable Stage IIIB with pleural effusion or stage IV NSCLC

- ECOG performance status of 0 or 1

Exclusion Criteria:

- Patients who received an IV bisphosphonate (e.g.pamidronate; zoledronic acid)

- Patients who received an oral bisphosphonate therapy in the 6 months prior to
screening (alendronate; etidronate; risedronate; tiludronate; ibandronate)

- Patients who are currently receiving any investigational drugs that are suspected to
have renal toxicity and/or are excreted by the kidneys

- Known clinically significant hypersensitivity to zoledronic acid or other
bisphosphonates or any of the excipients in the formulation of zoledronic acid
(mannitol, sodium citrate)

- Abnormal renal function or creatinine clearance

- Unstable brain metastasis

- Women of childbearing potential not using a medically recognized form of
contraception, as well as women who are breastfeeding

- Patients with nonmalignant conditions which would confound the evaluation of the
primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol