Non-small Cell Lung Cancer MedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult subjects with histologically or cytologically confirmed stage IV NSCLC who provide a tumor sample and are planned to receive 4-6 cycles of platinum-doublet based chemotherapy • Radiographically evaluable disease according to modified RECIST 1.1 criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 119 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 97
Exclusion criteria
Exclusion criteria: • Known presence of epidermal growth factor receptor (EGFR) mutation • Known brain metastases • Any prior therapy (before randomization) for the treatment of NSCLC, except if for non-metastatic disease and was completed at least 6 months prior to randomization • Planned to receive bevacizumab • Subjects with sarcomatoid, carcinoid, and mesenchymal histologies • More than 1 year of cumulative oral bisphosphonate usage prior to randomization • More than 1 previous dose of IV bisphosphonate administration prior to randomization • Significant dental/oral disease, including prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw • Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium, or vitamin D)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the treatment effect of the combination of denosumab and standard of care (SOC) versus SOC alone on overall survival (OS).;Secondary Objective: To assess whether any relative benefit on OS from the combination of denosumab and SOC versus SOC alone in NSCLC is associated with tumor RANK expression • To assess whether any relative benefit on objective response(OR) from the combination of denosumab and SOC versus SOC alone in NSCLC is associated with tumor RANK expression • To assess whether any relative benefit on OS from the combination of denosumab and SOC versus SOC alone in NSCLC is associated with tumor RANK ligand expression • To assess whether any relative benefit on OR from the combination of denosumab and SOC versus SOC alone in NSCLC is associated with tumor RANKL expression • To estimate the treatment effect of the combination of denosumab and SOC versus SOC alone on: o Objective response rate o Clinical benefit rate o Progression-free survival •To assess serum denosumab trough levels •To assess the safety and tolerability of denosumab compared with placebo in combination with standard of care therapy;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Primary analysis cut-off date is event-driven (i.e. when approximately 149 deaths occur) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Tumor tissue RANKL expression in correlation with o OS o Objective response rate (complete response [CR] + partial response [PR]) based on modified RECIST 1.1 (Appendix E of the protocol) • Objective response rate based on modified RECIST 1.1 • Clinical benefit rate ([all objective response] + [stable disease or better for at least 16 weeks]) based on modified RECIST 1.1 • PFS based on modified RECIST 1.1 • Serum denosumab trough levels • Treatment-emergent adverse events;Timepoint(s) of evaluation of this end point: Primary analysis cut-off date is event-driven (i.e. when approximately 149 deaths occur) | — |
Countries
Australia, Canada, Czech Republic, European Union, Germany, Greece, Netherlands, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info – Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed