Trial Information
A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer
Inclusion Criteria:
- Histologically or cytologically confirmed Non-small Cell Lung Cancer (NSCLC)
- Newly Diagnosed, Stage IIIA and Stage IIIB excluding patients with pleural effusion
- Patients must have received primary treatment for their disease and had no
progression
Exclusion Criteria:
- Diagnosed with NSCLC longer than 6 months ago
- Treatment with other bisphosphonates in past 12 months
- Presence of metastases
Other protocol-defined inclusion and exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Progression-Free Survival
Outcome Description:
Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Outcome Time Frame:
Up to 24 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
European Union: European Medicines Agency
Study ID:
CZOL446G2419
NCT ID:
NCT00172042
Start Date:
March 2005
Completion Date:
June 2010
Related Keywords:
- Non-Small-Cell Lung Cancer
- Non-Small-Cell Lung Cancer
- Bisphosphonates
- Zoledronic acid
- Bone metastases
- Prevention of bone metastases
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasm Metastasis
- Bone Neoplasms
- Bone Marrow Diseases