A Phase 2 Study with Denosumab in Non-Small Cell Lung Cancer
Research type
Research Study
Full title
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.
IRAS ID
135777
Contact name
Conrad Lewanski
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2013-001662-42
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
The purpose of this study is to find out more about denosumab in people with non-small cell lung cancer and what effect the addition of denosumab to platinum-based chemotherapy has on the disease. This study will look at whether this effect is related to certain biomarkers that may be present in the tumour cells. A biomarker is something in the blood and/or tissue that can be used to measure the status of disease and/or the effects of denosumab on the body. Also, the study will determine if the treatment with denosumab causes any side effects.
To do this, denosumab in combination with chemotherapy will be compared to placebo in combination with chemotherapy. At the dose at which it will be used in this study, denosumab has been approved by the regulatory health agencies in some countries (like the Food and Drug Administration [FDA] and the European Medicines Agency [EMA]) for use in people with bone metastasis from solid tumours for the prevention of skeletal complications.
Participants will attend treatment visits every 3-4 weeks where they will be dosed with either denosumab or placebo. At each dosing visit blood and urine samples will be taken. Tissue samples may also be collected if taking tissue samples is part of the participant’s routine care. The blood and tissue samples will be used to test biomarker development which will help determine how participants are responding to denosumab and enhance understanding of lung cancer. Some blood samples may be used to extract participant DNA in order to identify DNA modification which may help evaluate the effects on denosumab. This testing is optional and additional consent will be sought for this. Participants are expected to partake in the trial for up to 3 years.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0364
Date of REC Opinion
6 Dec 2013
REC opinion
Further Information Favourable Opinion