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)

Novartis

Status and phase: Completed; Phase 3

Conditions: Non-Small-Cell Lung Cancer

Treatments: Drug: Zoledronic acid 4 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00172042

CZOL446G2419

Details and patient eligibility

About

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).

Enrollment: 437 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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437 participants in 2 patient groups

Zoledronic acid

Experimental group

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.

Treatment:

Drug: Zoledronic acid 4 mg

Control

Other group

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.

Treatment:

Drug: Zoledronic acid 4 mg