NCT01951586

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Denosumab	Administered by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8; could be administered as often as every 3 weeks (Q3W) to participants receiving Q3W chemotherapy.
DRUG	Zoledronic acid	Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy.
DRUG	Placebo to Denosumab	Administered by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8; could be administered as often as every 3 weeks (Q3W) to participants receiving Q3W chemotherapy.
DRUG	Standard Chemotherapy	Standard of care chemotherapy consisting of pemetrexed or gemcitabine in combination with cisplatin or carboplatin administered according to local practice.
DRUG	Placebo to Zoledronic Acid	Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy.

Timeline

• Start date: 2013-12-31
• Primary completion: 2016-07-29
• Completion: 2017-11-28
• First posted: 2013-09-26
• Last updated: 2021-10-25
• Results posted: 2017-08-28

Locations

74 sites across 10 countries: United States, Australia, Canada, Czechia, France, Germany, Greece, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study