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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Cancer

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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

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