Relatlimab + Nivolumab + Chemo vs Nivolumab + Chemo in NSCLC
Research type
Research Study
Full title
A Phase 2 Randomized Double-blind Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy as First Line Treatment for Participants with Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
IRAS ID
277750
Contact name
Professor Fiona Blackhall
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2020-004026-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
150316, IND
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
The purpose of this study is to see how safe and effective relatlimab and nivolumab are when given in combination with chemotherapy in people who have non-small cell lung cancer (NSCLC). In this study, only individuals who have NSCLC that is advanced (Stage IV), or has come back (recurred), will be able to participate. There are 2 main parts to this study. In Part 1, different doses of relatlimab will be given together with nivolumab and chemotherapy to make sure that the study drug combination is safe and well tolerated in patients with NSCLC. In Part 1, the dose to be used in Part 2 will be found. In Part 2, participants will receive either nivolumab + relatlimab (at the dose determined from Part 1) with chemotherapy or nivolumab + placebo with chemotherapy. The purpose of the placebo in this study is to help the study doctors determine whether or not relatlimab and nivolumab with chemotherapy is more effective than nivolumab and chemotherapy alone.
The study is divided into 3 time periods: a Screening Period, a Treatment Period, and a Follow-Up Period. During each study period, participants will have 1 or more visits with the study doctor at the study clinic. The Screening Visit(s) will last about 6 hours. All other visits will take approximately 5 hours; however, this could be longer.REC name
London - Harrow Research Ethics Committee
REC reference
21/LO/0151
Date of REC Opinion
17 May 2021
REC opinion
Further Information Favourable Opinion