Trial comparing MK-2870 & pembro to pembro alone in people with NSCLC

• Research type

  Research Study

• Full title

  A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50%

• IRAS ID

  1008641

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC). NSCLC is a type of lung cancer.

  Current treatments for NSCLC may not work, or may stop working, for some people. MK-2870 (trial medicine) works on specific cancer cells to stop them from growing. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Researchers want to know if people who receive MK-2870 with pembrolizumab live longer overall than people who receive pembrolizumab alone.

  About 614 people, aged 18 years old and older, will be in the trial and:
  • Have newly diagnosed NSCLC and has not received prior treatment
  • Have provided a tumour tissue sample where the Programmed death-ligand 1 (PD-L1) is present in more than half of tumour cells
  • Do not have NSCLC with an epidermal growth factor receptor (EGFR) gene mutation or certain other gene mutations

  People will have an equal chance to receive 1 of 2 treatments:
  • MK-2870 with pembrolizumab
  • Pembrolizumab
  People will receive their treatment through a needle into a vein as an intravenous infusion.
  MK-2870 will be given once every 2 weeks until the cancer gets worse, or the researcher decides to stop treatment. Pembrolizumab will be given every 6 weeks for about 2 years.

  During the trial, people will give blood, urine, and tumour tissue, will have imaging tests and physical examinations, and answer questions about how they are feeling.

  Each person could be in the trial for up to 6 years.

  People may or may not benefit from the treatment received during the trial. This trial has an external group of experts that will oversee the overall risk and benefit. If this group of experts decides that the trial treatment is not safe or does not show benefit, the trial can be stopped.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  23/NE/0225

• Date of REC Opinion

  21 Dec 2023

• REC opinion

  Further Information Favourable Opinion