Overview

Non-small Cell Lung Cancer Registry

Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Diphosphonates
Zoledronic Acid
Criteria
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