Trial intelligence / Profile preview

Denosumab with Chemotherapy in Metastatic NSCLC

NCT01951586Phase 2

Key facts

Status: Completed
Start: Dec 2013
Primary completion: Jul 2016
Countries: 10
Sponsor: Amgen
Modality: Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies

Drugs: denosumab
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, randomised, double-blind trial in non-small cell lung cancer (NSCLC) comparing Denosumab Arm with Placebo Arm (2 arms). Primary endpoint: Overall Survival. Started Dec 2013; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Denosumab Arm
Denosumab + Standard Chemotherapy (+ Placebo ZA if bone mets)
Placebo Arm
Placebo + Standard Chemotherapy (+ Zoledronic Acid if bone mets)

Who it enrols

Stage IV NSCLC patients (with or without bone metastases) planned for first-line platinum-doublet chemotherapy, excluding those with EGFR/ALK mutations or brain metastases.

Endpoints

Primary

Overall SurvivalFrom randomization until end of study

Secondary

Correlation of Tumor Tissue RANK Expression With Overall SurvivalFrom randomization until data cut-off
Correlation of Tumor Tissue RANK Ligand Expression With Overall SurvivalFrom randomization until data cut-off
Objective Response RateFrom randomization until data cut-off
Clinical Benefit RateFrom randomization until data cut-off
Progression-free SurvivalFrom randomization until data cut-off
Serum Denosumab Trough LevelsUp to 24 weeks
Number of Participants With Treatment-emergent Adverse EventsFrom first dose to end of study

Results

Not all primary endpoints met

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