Phase 3
Completed N=437
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 (NSCLC)
Source: ClinicalTrials.gov NCT00172042 ↗Enrolled (actual)
437
Serious AEs
35.5%
Results posted
Jul 2011
Primary outcomePrimary: Progression-Free Survival — 9.0; 11.3 Months
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival |
9.0; 11.3 | — |
| PRIMARY Kaplan-Meier Estimates for Progression-free Survival |
63.0; 67.9; 44.4; 48.8; 30.7; 40.6 | — |
| PRIMARY Percentage of Participants With Progression-Free Survival Events |
60.2; 55.5; 8.4; 5.7 | — |
| SECONDARY Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months |
2.2; 4.3; 4.0; 7.1; 6.2; 8.1 | — |
| SECONDARY Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases |
2.7; 1.9; 4.2; 9.0; 11.1; 12.6 | — |
| SECONDARY Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry |
2.2; 1.4; 2.2; 1.4 | — |
| SECONDARY Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE) |
1.0; 0.0; 2.7; 1.8; 2.7; 1.8 | — |
| SECONDARY Kaplan-Meier Estimates for Overall Survival |
92.8; 93.6; 81.8; 81.8; 72.4; 71.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00172042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.