Non-small Cell Lung Cancer Registry

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

This trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is to see if a blood test can be used to predict when cancer-related bone lesions develop. This trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage IV non-small cell lung cancer that cannot be treated by surgery.

Intervention(s) in this Clinical Trial

• Drug: zoledronic acid

Primary Measures

• Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
• Group 2: Observational

Secondary Measures

• Patients with an SRE will be evaluated for:
• Time from stage IIIB/IV NSCLC diagnosis to progression to bone
• Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications
• The effect of serum NTX levels on the development of skeletal events (SREs), and
• Overall survival
• Group 2: Obervational

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

L. Lacerna, MD Study Chair Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00099541

Study ID Number: CZOL446EUS99

ClinicalTrials.gov Identifier: NCT00099541

Health Authority: United States: Institutional Review Board

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