BP29360 - RO5479599 in advanced or metastatic squamous NSCLC
Research type
Research Study
Full title
Open label phase Ib/II, multi-center study of the combination of RO5479599 with carboplatin and paclitaxel in patients with advanced or metastatic non small cell lung cancer (NSCLC) of squamous histology who have not received prior chemotherapy or targeted therapy for NSCLC
IRAS ID
157309
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2014-001498-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 25 days
Research summary
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Squamous NSCLC is a sub-type of NSCLC and accounts for approximately 30% of all NSCLC cases. Advanced/metastatic squamous NSCLC remains difficult to treat and there is a high need for new treatment options to improve the overall survival of these patients.
There is a protein called HER3 which is frequently located in NSCLC tumour cells. Preclinical experiments have shown that the study drug, RO5479599, is able to bind to this HER3 protein which slowed down tumour growth and decreased the size of the tumour.
The purpose of this study is to find out more about how the study drug, RO5479599, works and how it is tolerated by the human body. We hope to learn if the combination of the three treatments (RO5479599, paclitaxel and carboplatin) is safe, can be tolerated and if they can slow down tumour growth or decrease the size of the tumour.
Patients with advanced/metastatic squamous NSCLC, who have not received prior therapy for NSCLC, may be eligible for inclusion in this study. The study is being conducted at specialist cancer centres in the UK (and internationally). A total of approximately 53 patients will be recruited into this study. In the UK it is expected that a total of 4 patients will be enrolled at 2 participating centres.
Participants will receive the treatments, as an infusion through a vein in their arm, every three weeks until they are no longer benefiting from the treatment.
Throughout the study, participants will be seen frequently at clinic visits and will undergo tests (e.g. CT scans, tumour biopsy, heart tests, blood tests, urine tests, saliva and sputum tests) to monitor the safety of the treatment and its effects on cancer. The study is sponsored by the pharmaceutical company Roche.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
15/SC/0315
Date of REC Opinion
8 Jun 2015
REC opinion
Favourable Opinion