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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
437
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).
Novartis Investigative Site
Jette, Belgium
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Liège, Belgium
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Guangzhou, China
Novartis Investigative Site
Progression-Free Survival
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.
Time frame: Up to 24 months
Kaplan-Meier Estimates for Progression-free Survival
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.
Time frame: Months 6, 12, 18, and 24
Percentage of Participants With Progression-Free Survival Events
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.
Time frame: Up to 24 months
Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 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 frame: Months 6, 12, 18 and 24
Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases
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).
Time frame: Months 6, 12, 18, and 24
Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry
Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.
Time frame: Months 12 and 24
Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)
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
Time frame: Months 6,12, 18, and 24
Kaplan-Meier Estimates for Overall Survival
Time frame: Months 6, 12, 18, and 24
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Shanghai, China
Novartis Investigative Site
Clamart, France
Novartis Investigative Site
Clémont, France
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Coburg, Germany
...and 59 more locations