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)

• Progression-Free Survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  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.
• Kaplan-Meier Estimates for Progression-free Survival [ Time Frame: Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  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.
• Percentage of Participants With Progression-Free Survival Events [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.

• Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months [ Time Frame: Months 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
  Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).
• Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases [ Time Frame: Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  Time to occurrence of bone metastases was defined as the time from randomization to the date of the first documented bone metastases which could be asymptomatic or symptomatic at the time of detection. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).
• Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry [ Time Frame: Months 12 and 24 ] [ Designated as safety issue: No ]
  Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.
• Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE) [ Time Frame: Months 6,12, 18, and 24 ] [ Designated as safety issue: No ]
  Time to the first skeletal related event defined as the time from randomization to the date of occurrence of the first SRE. Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event
• Kaplan-Meier Estimates for Overall Survival [ Time Frame: Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]

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).

• Experimental: Zoledronic acid
  Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
  Intervention: Drug: Zoledronic acid 4 mg
• No Intervention: Control
  No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
  Intervention: Drug: Zoledronic acid 4 mg

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.