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)

Non-Small-Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00172042
• Other study ID #: CZOL446G2419
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: April 13, 2015
• Start date: March 2005
• Est. completion date: June 2010

Study information

• Verified date: April 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

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).

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Jette
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Liege
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Guangzhou
China	Novartis Investigative Site	Shanghai
France	Novartis Investigative Site	Clamart
France	Novartis Investigative Site	Clemont
Germany	Novartis Investigative Site	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
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Patra - RIO
Greece	Novartis Investigative Site	Thessaloniki
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Deszk
Hungary	Novartis Investigative Site	Matrahaza
Hungary	Novartis Investigative Site	Pecs
Italy	Novartis Investigative Site	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
Korea, Republic of	Novartis Investigative Site	Seoul
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Eindhoven
Netherlands	Novartis Investigative Site	Hertogenbosch
Netherlands	Novartis Investigative Site	Hoofddorp
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Olsztyn
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Warszawa
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
Spain	Novartis Investigative Site	Alicante
Spain	Novartis Investigative Site	Donostia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga
Spain	Novartis Investigative Site	Sabadell
Taiwan	Novartis Investigative Site	Lin-Ko
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chaingmai
United Kingdom	Novartis Investigative Site	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  China,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 months	No
Primary	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.	Months 6, 12, 18, and 24	No
Primary	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.	Up to 24 months	No
Secondary	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).	Months 6, 12, 18 and 24	No
Secondary	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).	Months 6, 12, 18, and 24	No
Secondary	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.	Months 12 and 24	No
Secondary	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	Months 6,12, 18, and 24	No
Secondary	Kaplan-Meier Estimates for Overall Survival		Months 6, 12, 18, and 24	No