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)

April 13, 2015 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

437

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Jette, Belgium
        • Novartis Investigative Site
      • Leuven, Belgium
        • Novartis Investigative Site
      • Liege, Belgium
        • Novartis Investigative Site
  • China
      • Beijing, China
        • Novartis Investigative Site
      • Guangzhou, China
        • Novartis Investigative Site
      • Shanghai, China
        • Novartis Investigative Site
  • France
      • Clamart, France
        • Novartis Investigative Site
      • Clemont, France
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Coburg, Germany
        • Novartis Investigative Site
      • Essen, Germany
        • Novartis Investigative Site
      • Halle, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Heidelberg, Germany
        • Novartis Investigative Site
      • Koeln, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Ludwigsburg, Germany
        • Novartis Investigative Site
      • Mannheim, Germany
        • Novartis Investigative Site
      • Muenchen, Germany
        • Novartis Investigative Site
      • Neumuenster, Germany
        • Novartis Investigative Site
      • Trier, Germany
        • Novartis Investigative Site
      • Ulm, Germany
        • Novartis Investigative Site
  • Greece
      • Athens, Greece
        • Novartis Investigative Site
      • Patra - RIO, Greece
        • Novartis Investigative Site
      • Thessaloniki, Greece
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary
        • Novartis Investigative Site
      • Deszk, Hungary
        • Novartis Investigative Site
      • Matrahaza, Hungary
        • Novartis Investigative Site
      • Pecs, Hungary
        • Novartis Investigative Site
  • Italy
      • Bergamo, Italy
        • Novartis Investigative Site
      • Carpi, Italy
        • Novartis Investigative Site
      • Catania, Italy
        • Novartis Investigative Site
      • Como, Italy
        • Novartis Investigative Site
      • Cosenza, Italy
        • Novartis Investigative Site
      • Livorno, Italy
        • Novartis Investigative Site
      • Novara, Italy
        • Novartis Investigative Site
      • Orbassano, Italy
        • Novartis Investigative Site
      • Padova, Italy
        • Novartis Investigative Site
      • Reggio Calabria, Italy
        • Novartis Investigative Site
      • Rome, Italy
        • Novartis Investigative Site
      • Taormina, Italy
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands
        • Novartis Investigative Site
      • Eindhoven, Netherlands
        • Novartis Investigative Site
      • Hertogenbosch, Netherlands
        • Novartis Investigative Site
      • Hoofddorp, Netherlands
        • Novartis Investigative Site
  • Poland
      • Lodz, Poland
        • Novartis Investigative Site
      • Olsztyn, Poland
        • Novartis Investigative Site
      • Poznan, Poland
        • Novartis Investigative Site
      • Warszawa, Poland
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal
        • Novartis Investigative Site
      • Lisboa, Portugal
        • Novartis Investigative Site
      • Porto, Portugal
        • Novartis Investigative Site
  • Spain
      • Alicante, Spain
        • Novartis Investigative Site
      • Donostia, Spain
        • Novartis Investigative Site
      • Madrid, Spain
        • Novartis Investigative Site
      • Malaga, Spain
        • Novartis Investigative Site
      • Sabadell, Spain
        • Novartis Investigative Site
  • Taiwan
      • Lin-Ko, Taiwan
        • Novartis Investigative Site
      • Taichung, Taiwan
        • Novartis Investigative Site
      • Taipei, Taiwan
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand
        • Novartis Investigative Site
      • Chaingmai, Thailand
        • Novartis Investigative Site
  • United Kingdom
      • Aberdeen, United Kingdom
        • Novartis Investigative Site
      • Leeds, United Kingdom
        • Novartis Investigative Site
      • Leicester, United Kingdom
        • Novartis Investigative Site
      • London, United Kingdom
        • Novartis Investigative Site
      • Nottingham, United Kingdom
        • Novartis Investigative Site
      • Sutton, United Kingdom
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Zoledronic acid 4 mg
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).
Other Names:
  • Zometa®
Other: 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.
Drug: Zoledronic acid 4 mg
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).
Other Names:
  • Zometa®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: Up to 24 months
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.
Up to 24 months
Kaplan-Meier Estimates for Progression-free Survival
Time Frame: Months 6, 12, 18, and 24
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.
Months 6, 12, 18, and 24
Percentage of Participants With Progression-Free Survival Events
Time Frame: Up to 24 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.
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months
Time Frame: Months 6, 12, 18 and 24
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).
Months 6, 12, 18 and 24
Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases
Time Frame: Months 6, 12, 18, and 24
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).
Months 6, 12, 18, and 24
Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry
Time Frame: Months 12 and 24
Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.
Months 12 and 24
Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)
Time Frame: Months 6,12, 18, and 24
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
Months 6,12, 18, and 24
Kaplan-Meier Estimates for Overall Survival
Time Frame: Months 6, 12, 18, and 24
Months 6, 12, 18, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446G2419

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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