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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)

Primary Purpose

Non-Small-Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zoledronic acid 4 mg
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Small-Cell Lung Cancer focused on measuring Non-Small-Cell Lung Cancer, Bisphosphonates, Zoledronic acid, Bone metastases, Prevention of bone metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Zoledronic acid

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).
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).
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.
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
Kaplan-Meier Estimates for Overall Survival

Full Information

First Posted
September 13, 2005
Last Updated
April 13, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00172042
Brief Title
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)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Cancer
Keywords
Non-Small-Cell Lung Cancer, Bisphosphonates, Zoledronic acid, Bone metastases, Prevention of bone metastases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
437 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic acid
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
Zoledronic acid 4 mg
Other Intervention Name(s)
Zometa®
Intervention Description
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).
Primary Outcome Measure Information:
Title
Progression-Free Survival
Description
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
Title
Kaplan-Meier Estimates for Progression-free Survival
Description
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
Title
Percentage of Participants With Progression-Free Survival Events
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months
Description
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
Title
Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases
Description
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
Title
Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry
Description
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
Title
Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)
Description
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
Title
Kaplan-Meier Estimates for Overall Survival
Time Frame
Months 6, 12, 18, and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Jette
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
Country
Belgium
Facility Name
Novartis Investigative Site
City
Beijing
Country
China
Facility Name
Novartis Investigative Site
City
Guangzhou
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
Country
China
Facility Name
Novartis Investigative Site
City
Clamart
Country
France
Facility Name
Novartis Investigative Site
City
Clemont
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Coburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
Country
Germany
Facility Name
Novartis Investigative Site
City
Halle
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigative Site
City
Ludwigsburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Mannheim
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
Country
Germany
Facility Name
Novartis Investigative Site
City
Neumuenster
Country
Germany
Facility Name
Novartis Investigative Site
City
Trier
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
Country
Germany
Facility Name
Novartis Investigative Site
City
Athens
Country
Greece
Facility Name
Novartis Investigative Site
City
Patra - RIO
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
Country
Greece
Facility Name
Novartis Investigative Site
City
Budapest
Country
Hungary
Facility Name
Novartis Investigative Site
City
Deszk
Country
Hungary
Facility Name
Novartis Investigative Site
City
Matrahaza
Country
Hungary
Facility Name
Novartis Investigative Site
City
Pecs
Country
Hungary
Facility Name
Novartis Investigative Site
City
Bergamo
Country
Italy
Facility Name
Novartis Investigative Site
City
Carpi
Country
Italy
Facility Name
Novartis Investigative Site
City
Catania
Country
Italy
Facility Name
Novartis Investigative Site
City
Como
Country
Italy
Facility Name
Novartis Investigative Site
City
Cosenza
Country
Italy
Facility Name
Novartis Investigative Site
City
Livorno
Country
Italy
Facility Name
Novartis Investigative Site
City
Novara
Country
Italy
Facility Name
Novartis Investigative Site
City
Orbassano
Country
Italy
Facility Name
Novartis Investigative Site
City
Padova
Country
Italy
Facility Name
Novartis Investigative Site
City
Reggio Calabria
Country
Italy
Facility Name
Novartis Investigative Site
City
Rome
Country
Italy
Facility Name
Novartis Investigative Site
City
Taormina
Country
Italy
Facility Name
Novartis Investigative Site
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Amsterdam
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Eindhoven
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hertogenbosch
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hoofddorp
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Lodz
Country
Poland
Facility Name
Novartis Investigative Site
City
Olsztyn
Country
Poland
Facility Name
Novartis Investigative Site
City
Poznan
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
Country
Poland
Facility Name
Novartis Investigative Site
City
Coimbra
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
Country
Portugal
Facility Name
Novartis Investigative Site
City
Alicante
Country
Spain
Facility Name
Novartis Investigative Site
City
Donostia
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
Country
Spain
Facility Name
Novartis Investigative Site
City
Malaga
Country
Spain
Facility Name
Novartis Investigative Site
City
Sabadell
Country
Spain
Facility Name
Novartis Investigative Site
City
Lin-Ko
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Bangkok
Country
Thailand
Facility Name
Novartis Investigative Site
City
Chaingmai
Country
Thailand
Facility Name
Novartis Investigative Site
City
Aberdeen
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leeds
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leicester
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Nottingham
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Sutton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22730101
Citation
Scagliotti GV, Kosmidis P, de Marinis F, Schreurs AJM, Albert I, Engel-Riedel W, Schallier D, Barbera S, Kuo HP, Sallo V, Perez JR, Manegold C. Zoledronic acid in patients with stage IIIA/B NSCLC: results of a randomized, phase III study. Ann Oncol. 2012 Aug;23(8):2082-2087. doi: 10.1093/annonc/mds128. Epub 2012 Jun 22.
Results Reference
derived

Learn more about this trial

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)

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