CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 437 enrolled
Drug / intervention
Zoledronic acid 4 mgdrug
Likely dose
Zoledronic acid 4 mg IV infusion in 100 mL calcium-free solutionAI-extracted
Key inclusion· 3
  • ✓Histologically or cytologically confirmed NSCLC
  • ✓Stage IIIA or IIIB disease, excluding pleural effusion
  • ✓Completed primary treatment with no disease progression
Key exclusion· 3
  • ✕NSCLC diagnosed >6 months ago
  • ✕Prior bisphosphonate therapy within 12 months
  • ✕Presence of metastases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00172042
NCT00172042Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Sep 15, 2005·Updated May 4, 2015

In Brief

A Phase 3 clinical trial evaluating Zoledronic acid 4 mg for Non-Small-Cell Lung Cancer. Completed, enrolled 437 participants across 69 sites in 15 countries.

Detailed Summary

30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small-Cell Lung Cancer
CountriesBelgium, China, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, South Korea, Spain, Taiwan, Thailand, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartMar 1, 2005
Primary CompletionMay 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 20.8 years ago

Interventions

Zoledronic acid 4 mgdrug

Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).