CA209-227 - Nivolumab or nivolumab plus ipilimumab vs SOC in NSCLC
Research type
Research Study
Full title
An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab plus Ipilimumab, versus platinum doublet chemotherapy in Subjects with Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
IRAS ID
174852
Contact name
Valerie Perpette
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2014-003630-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 3 days
Research summary
Lung cancer is the second most common cancer in the UK and the most common cause of cancer related deaths in men and women. The most common form is non-small cell lung cancer (NSCLC). A significant number of NSCLC patients have advanced cancer at diagnosis, and unfortunately with current standard treatment survival rate remains poor, with less than 5% of patients with advanced disease alive five years on from diagnosis. This is a clinical trial of a novel immune therapy called nivolumab, either alone or combined with another immune therapy called ipilimumab, compared with chemotherapy alone (the current standard).
Nivolumab is a new type of immunotherapy drug which stimulates the body’s own immune system to help attack cancer cells. It works by blocking a protein on the body’s immune cells, called PD1, so that tumours can be recognised as foreign and attacked by the immune system. Ipilimumab is already on the market in the UK for the treatment of melanoma, a type of skin cancer.
Following a screening period, eligible patients will be randomised to 1 of 6 treatment arms depending on their PDL1 status and their type of NSCLC. Patients will receive either nivolumab; one of two regimens of nivolumab and ipilimumab in combination or chemotherapy. Patients will receive nivolumab and ipilimumab until their cancer gets worse or their doctor decides they should come out of the study (except for the chemotherapy arm). Patients will undergo the following procedures during the study: tumour tissue biopsy (possible), CT/MRI scans, physical exams, vital signs and blood sampling for routine safety testing and study specific testing.
Patients will be treated by trained oncology teams in specialised NHS clinics. 1980 patients are to be treated in the study with approximately 60 being treated in the UK. The study is sponsored by Bristol-Myers Squibb.REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0475
Date of REC Opinion
28 Aug 2015
REC opinion
Favourable Opinion