Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

Official Title

A Randomized, Double-blind, Multi-centre Phase 2 Trial of Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

Summary:

This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.

Trial Description

Primary Outcome:

• Overall Survival (OS)

Secondary Outcome:

• Correlation of Tumour Tissue RANK Expression With Overall Survival
• Correlation of Tumour Tissue RANK Ligand Expression With Overall Survival
• Objective Response Rate
• Correlation of Tumour Tissue RANK Expression With Objective Response Rate
• Correlation of Tumour Tissue RANKL Expression With Objective Response Rate
• Clinical Benefit Rate
• Progression-free Survival (PFS)
• Serum Denosumab Trough Levels in Participants Who Received Q3W Dosing
• Serum Denosumab Trough Levels in Participants Who Received Q4W Dosing
• Number of Participants With Treatment-emergent Adverse Events

This is a global randomized double-blind placebo-controlled study in patients with Stage IV untreated non-small cell lung cancer (NSCLC) with or without bone metastasis. Eligible participants are to receive 4 to 6 cycles of a standard of care platinum-doublet chemotherapy regimen. Participants will be randomized in a 2:1 ratio to receive denosumab or matching placebo with the first investigational product dose coinciding with participant's first cycle of chemotherapy and continuing until the primary analysis, unacceptable toxicity, withdrawal of consent, death, or lost to follow-up. Participants who discontinued the investigational product early (ie, before primary analysis) were followed for disease status and survival. The primary analysis took place when 149 events of death had been reported. All participants were followed for 2 years after the last dose of blinded investigational product.

View this trial on ClinicalTrials.gov