CA209-331 Nivolumab vs Chemotherapy in SCLC
Research type
Research Study
Full title
An Open-Label,Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects with Relapsed Small-cell Lung Cancer after Platinum based First Line Chemotherapy
IRAS ID
187302
Contact name
Timothy Yap
Contact email
Sponsor organisation
Bristol-Myers Squibb
Eudract number
2015-001097-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 16 days
Research summary
Summary of Research
Lung cancer is the second most common cancer in the UK and the most common cause of cancer related deaths in men and women. Small-cell Lung cancer (SCLC) is a form of lung cancer. Most SCLC patients have advanced cancer at diagnosis, and unfortunately with current standard chemotherapy and radiation treatment survival remains poor, with less than 5% of patients with advanced disease alive five years on from diagnosis. This is a clinical trial of an immune therapy called nivolumab compared with chemotherapy alone (the current standard).
Nivolumab is a new type of immunotherapy drug which is designed to stimulates the body’s own immune system to help attack cancer cells.
Following a screening period, eligible patients will be randomised to 1 of 2 treatment arms. Patients will receive either nivolumab or a chemotherapy called Topotecan. Patients will receive nivolumab or Topotecan until their cancer gets worse or their doctor decides they should come out of the study. 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 also undergo an ECG and Echo.
Patients will be treated by trained oncology teams in specialised NHS clinics. 480 patients are to be treated in the study with approximately 24 being treated in the UK. The study is sponsored by Bristol-Myers Squibb.REC name
London - Central Research Ethics Committee
REC reference
15/LO/1807
Date of REC Opinion
2 Nov 2015
REC opinion
Favourable Opinion