CA266-0002 ROSETTA Lung-202

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%.

• IRAS ID

  1013492

• Contact name

  GSM-CT Representative

• Contact email

  mg-gsm-ct@bms.com

• Sponsor organisation

  Bristol-Myers Squibb Services Unlimited Company

• Eudract number

  2025-523586-18

• Research summary

  This study is testing a new medicine called pumitamig and comparing it with pembrolizumab, which is a commonly used treatment for non-small cell lung cancer (NSCLC that is locally advanced (spread to nearby tissues in the chest) or metastatic (spread to other parts of your body outside the lung) and has a high level of a protein called PD L1. The aim is to find out whether pumitamig can help people live longer and stop their cancer from getting worse for longer than current standard treatment.
  The study is for adults aged 18 years or older who have a specific type of NSCLC (squamous and non-squamous) advanced stage disease (stage IIIB/IIIC or IV) and are not suitable for surgery to remove the cancer. The cancer may be confined to the chest (locally advanced) or may have spread to other parts of the body (metastatic). The tumour must express a protein called programmed death receptor ligand-1 (PD-L1) which affects how well the body fights cancer cells.
  Pumitamig is still being researched. Doctors are studying how well it works and what side effects it may cause. It has not yet been approved for use in this type of lung cancer.
  Around 750 people worldwide, including people in the UK, will take part in this study.
  The study has four stages:
  1. Screening – Hospital tests over 2–3 visits in about 4 weeks to check if someone can join.
  2. Treatment – Visits every 3 weeks for up to 2 years, or until the cancer worsens, side effects become unacceptable, or the participant chooses to stop.
  3. Safety follow up – Health checks at 30 and 90 days after the last dose.
  4. Long term follow up – Telephone health checks every 12 weeks for up to 7 years or until the study ends

• REC name

  Wales REC 2

• REC reference

  26/WA/0035

• Date of REC Opinion

  25 Mar 2026

• REC opinion

  Further Information Favourable Opinion