Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplastic Processes

Pharmaceutical Solutions

All Drugs and Chemicals

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Zoledronic Acid

Diphosphonates

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.

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.

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).

Zoledronic acid 4 mg

Novartis Pharmaceuticals

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).

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)

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

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 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 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).

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).

Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.

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

Safety results are subsequently presented according to treatment actually received at the start of the study (224 in zoledronic acid arm, 213 in control arm); two patients were randomized to the zoledronic acid arm but did not receive study drug at the start of the study hence included into control arm for safety analysis.

Control

Total

Age, Continuous

Sex: Female, Male

Study Director

Intent-to-Treat Population consisting of all randomized participants.

Progression-Free Survival

6 months

12 months

18 months

24 months

Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months

Intent-to-Treat Population consisting of all randomized participants. Any participant without documented bone metastases at the date of analysis was to be censored at the date of the last bone scan.

Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases

Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry

6 month

12 month

18 month

24 month

Intent-to-Treat Population consisting of all randomized participants. Any participant in whom no SRE had been observed during the study was to be censored at the date of the last visit or the date of death whichever was the earlier.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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)	NCT00172042	Non-Small-Cell ...	Zoledronic acid...	18 Years -	Novartis
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)	NCT00172042	Non-Small-Cell ...	Zoledronic acid...	18 Years -	Novartis

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