CA209-73L-Comparison of 3 treatments including Nivo plus CCRT in NSCLC
Research type
Research Study
Full title
A Phase 3, Randomized, Open Label Study to Compare Nivolumab plus Concurrent Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT Followed by Nivolumab vs CCRT followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
IRAS ID
268815
Contact name
Head of Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2019-001222-98
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
41336, NIHR Reference Number
Duration of Study in the UK
4 years, 6 months, 12 days
Research summary
This is a multicentre, phase 3 study in patients with untreated non-small cell lung cancer that is locally advanced. This study will compare treatment with nivolumab given at the same time as chemotherapy and radiotherapy (known as concurrent chemoradiotherapy or CCRT) followed by treatment with either nivolumab and ipilimumab or nivolumab alone, or CCRT followed by durvalumab. The objective is to see whether one treatment regimen will significantly improve the overall survival and the length of time before the cancer gets worse after treatment (progression free survival), compared to the others.
888 patients will take part in this study with 28 in the UK.
Patients will be randomly assigned to one of the 3 treatment arms below:
• Arm A – nivolumab + CCRT followed by maintenance period of nivolumab plus ipilimumab for up to 12 months
• Arm B – nivolumab + CCRT followed by maintenance period of only nivolumab for up to 12 months
• Arm C – CCRT followed by durvalumab for up to 12 months
Between the CCRT period and the maintenance period, there will be a recovery period up to 42 days.
Treatment will be discontinued if patient withdraws consent, if their cancer gets worse or if for any reason it is no longer safe for the patient to continue in the trial.
Patients will have the following procedures while on treatment: vital signs (temperature, heart rate and blood pressure), lung function tests, CT scans, physical exams, ECGs and blood sampling. They will also regularly complete questionnaires on how they are feeling. A fresh tissue biopsy will be collected at screening if existing tissue is not available or cannot be used. Patients will have follow-up visits after the end of their treatment. These visits are mainly to check the patient is well and not suffering any ill effects from the treatment.REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0137
Date of REC Opinion
22 Aug 2019
REC opinion
Further Information Favourable Opinion