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NCT Number: NCT00172042

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)

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).

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Jette, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Zometa®

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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

  5. Kaplan-Meier Estimates for Overall Survival

    Time frame: Months 6, 12, 18, and 24

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 15, 2005
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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