At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Denosumab, Zoledronic acid, and 3 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 226 participants across 74 sites in 10 countries.
Detailed Summary
This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.
Study Details
Timeline
Interventions
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.
Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy.
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.
Standard of care chemotherapy consisting of pemetrexed or gemcitabine in combination with cisplatin or carboplatin administered according to local practice.
Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy.