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 | Completed Phase 3 Results

• 1 other identifier: CZOL446G2419
• Study Type: interventional
• Target: 437
• Locations: 15 countries
• Sites: 69

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).

Conditions

Non-Small-Cell Lung Cancer

Keywords

Non-Small-Cell Lung Cancer; Bisphosphonates; Zoledronic acid; Bone metastases; Prevention of bone metastases

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (5)

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

  Months 6, 12, 18 and 24

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

  Months 6, 12, 18, and 24

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

  Months 12 and 24

• Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)

  Months 6,12, 18, and 24

• Kaplan-Meier Estimates for Overall Survival

  Months 6, 12, 18, and 24

Study Arms (2)

Zoledronic acid

EXPERIMENTAL

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

Control

OTHER

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

Interventions

Zoledronic acid 4 mg DRUG

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).

Also known as: Zometa®

Control; Zoledronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosed with NSCLC longer than 6 months ago
• Treatment with other bisphosphonates in past 12 months
• Presence of metastases

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (69)

Novartis Investigative Site

Jette, Belgium

Location

Novartis Investigative Site

Leuven, Belgium

Location

Novartis Investigative Site

Liège, Belgium

Location

Novartis Investigative Site

Beijing, China

Location

Novartis Investigative Site

Guangzhou, China

Location

Novartis Investigative Site

Shanghai, China

Location

Novartis Investigative Site

Clamart, France

Location

Novartis Investigative Site

Clémont, France

Location

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Coburg, Germany

Location

Novartis Investigative Site

Cologne, Germany

Location

Novartis Investigative Site

Essen, Germany

Location

Novartis Investigative Site

Halle, Germany

Location

Novartis Investigative Site

Hamburg, Germany

Location

Novartis Investigative Site

Heidelberg, Germany

Location

Novartis Investigative Site

Leipzig, Germany

Location

Novartis Investigative Site

Ludwigsburg, Germany

Location

Novartis Investigative Site

Mannheim, Germany

Location

Novartis Investigative Site

München, Germany

Location

Novartis Investigative Site

Neumünster, Germany

Location

Novartis Investigative Site

Trier, Germany

Location

Novartis Investigative Site

Ulm, Germany

Location

Novartis Investigative Site

Athens, Greece

Location

Novartis Investigative Site

Patra - RIO, Greece

Location

Novartis Investigative Site

Thessaloniki, Greece

Location

Novartis Investigative Site

Budapest, Hungary

Location

Novartis Investigative Site

Deszk, Hungary

Location

Novartis Investigative Site

Mátraháza, Hungary

Location

Novartis Investigative Site

Pécs, Hungary

Location

Novartis Investigative Site

Bergamo, Italy

Location

Novartis Investigative Site

Carpi, Italy

Location

Novartis Investigative Site

Catania, Italy

Location

Novartis Investigative Site

Como, Italy

Location

Novartis Investigative Site

Cosenza, Italy

Location

Novartis Investigative Site

Livorno, Italy

Location

Novartis Investigative Site

Novara, Italy

Location

Novartis Investigative Site

Orbassano, Italy

Location

Novartis Investigative Site

Padua, Italy

Location

Novartis Investigative Site

Reggio Calabria, Italy

Location

Novartis Investigative Site

Rome, Italy

Location

Novartis Investigative Site

Taormina, Italy

Location

Novartis Investigative Site

's-Hertogenbosch, Netherlands

Location

Novartis Investigative Site

Amsterdam, Netherlands

Location

Novartis Investigative Site

Eindhoven, Netherlands

Location

Novartis Investigative Site

Hoofddorp, Netherlands

Location

Novartis Investigative Site

Lodz, Poland

Location

Novartis Investigative Site

Olsztyn, Poland

Location

Novartis Investigative Site

Poznan, Poland

Location

Novartis Investigative Site

Warsaw, Poland

Location

Novartis Investigative Site

Coimbra, Portugal

Location

Novartis Investigative Site

Lisbon, Portugal

Location

Novartis Investigative Site

Porto, Portugal

Location

Novartis Investigative Site

Seoul, South Korea

Location

Novartis Investigative Site

Alicante, Spain

Location

Novartis Investigative Site

Donostia / San Sebastian, Spain

Location

Novartis Investigative Site

Madrid, Spain

Location

Novartis Investigative Site

Málaga, Spain

Location

Novartis Investigative Site

Sabadell, Spain

Location

Novartis Investigative Site

Lin-Ko, Taiwan

Location

Novartis Investigative Site

Taichung, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan

Location

Novartis Investigative Site

Bangkok, Thailand

Location

Novartis Investigative Site

Chaingmai, Thailand

Location

Novartis Investigative Site

Aberdeen, United Kingdom

Location

Novartis Investigative Site

Leeds, United Kingdom

Location

Novartis Investigative Site

Leicester, United Kingdom

Location

Novartis Investigative Site

London, United Kingdom

Location

Novartis Investigative Site

Nottingham, United Kingdom

Location

Novartis Investigative Site

Sutton, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22730101 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 4, 2015
• Results First Posted: July 19, 2011

Record last verified: 2015-04

Locations

PT (3); TW (3); FR (2); CN (3); GR (3); KR (1); PL (4); TH (2); BE (3); ES (5); HU (4); NL (4); IT (12); DE (14); GB (6)