CA209-9LA Nivolumab combination in patients with NSCLC
Research type
Research Study
Full title
A Study of Nivolumab plus Ipilimumab in Combination with Chemotherapy vs. Chemotherapy alone as First Line Therapy in stage IV Non-Small Cell Lung Cancer (NSCLC)
IRAS ID
229129
Contact name
James Spicer
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2017-001195-35
Duration of Study in the UK
3 years, 3 months, 23 days
Research summary
Non-small cell lung cancer (NSCLC) remains the leading cause of cancer-related deaths worldwide, accounting for approximately 18% of all cancer deaths. Patients with advanced NSCLC treated with the standard first line platinum-based chemotherapy survive around 10 months, and at 5 years less than 5% of these patients are alive.
The main purpose of the study is to see if nivolumab and ipilimumab in combination with chemotherapy is better at improving survival when compared to standard platinum-based chemotherapy. This study will also test the effectiveness (how well the drug works), safety, and tolerability of the combination in patients with advanced NSCLC.
Nivolumab and ipilimumab are types of immunotherapy which stimulate the body’s own immune system to attack cancer cells. Nivolumab is now approved in the US and Europe to treat advanced NSCLC in patients who have already had platinum-based chemotherapy. Ipilimumab is already on the market in the UK for the treatment of melanoma, a type of skin cancer.
In an earlier trial in advanced NSCLC patients ipilimumab enhanced nivolumab’s anti-cancer activity. Two cycles of chemotherapy may be helpful to control cancer symptoms and tumor growth quickly and may be sufficient to also enhance the effects of nivolumab and ipilimumab.
In this trial, patients will undergo screening tests to check that it is safe for them to take part in the trial. Those patients who are suitable will be randomly allocated to receive either nivolumab and ipilimumab plus platinum-based chemotherapy or platinum-based chemotherapy alone.
Patients will undergo the following procedures during the study: tumor tissue biopsy (possible), CT/MRI scans, physical exams, blood sampling for routine safety testing and study specific testing.
420 patients are to be treated in the study with approximately 16-24 to be treated in the UK. The study is sponsored by Bristol-Myers Squibb.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/1488
Date of REC Opinion
22 Nov 2017
REC opinion
Further Information Favourable Opinion