CA2241093 Nivo+Rela FDC + Chemo vs Pembro + Chemo in NSQ Stage 4 NSCLC

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and with Tumor Cell PD-L1 expression greater than or equal to 1%

• IRAS ID

  1010536

• Contact name

  GSM-CT Representative

• Contact email

  mg-gsm-ct@bms.com

• Sponsor organisation

  Bristol-Myers Squibb Services Unlimited Company

• Clinicaltrials.gov Identifier

  NCT06561386

• Research summary

  Study CA2241093 (RELATIVITY-1093) is a global study of a new cancer therapy (nivolumab + relatlimab fixed dose combination) called BMS 986213. The study will compare BMS 986213 with chemotherapy against the standard of care treatment, pembrolizumab with chemotherapy, in participants with non-squamous (NSQ) non-small cell lung cancer (NSCLC).
  Participants will be: 18 years or older; have NSCLC that is advanced (stage IV) or has come back (recurred); and have tumours that express a protein called programmed death receptor ligand-1 (PD-L1) which affect how well the body fights cancer cells.
  BMS 986213 is an immunotherapy drug that affects the body’s defence (immune) system. It is not approved for advanced lung cancer. It is being researched to understand its side effects and how well it works. Researchers think BMS986213 may lead to an improved immune response and promote tumour cell death. Pembrolizumab is an immunotherapy drug approved for the treatment of patients with advanced lung cancer.
  About 800 participants will take part in this study world-wide including about 29 in the UK.
  The study has three parts: a screening period, treatment period, and a follow-up period. During each period, participants will have two or more visits to the study hospital with the study team to undergo tests and review their health.
  Participants will receive treatment for up to 2 years, until their cancer gets worse, they choose to leave the study, the study doctor decides it is best for them to stop treatment or the study is ended. Follow-up visits will take place at the hospital after treatment has ended. Afterwards, some follow-up visits may be done by the study team by telephone.

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  24/NS/0136

• Date of REC Opinion

  19 Dec 2024

• REC opinion

  Further Information Favourable Opinion