MK-3475A SC vs Pembrolizumab IV for PD-L1 TPS Strong Metastatic NSCLC

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater

• IRAS ID

  1010155

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06698042

• Research summary

  Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that:
  • Is metastatic, which means cancer has spread to other parts of the body
  • Has a high level of PD-L1 on the cancer cells. PD-L1 is a type of protein found on cancer cells that can help the cancer hide from the body’s immune system.
  Standard treatment for people with this type of metastatic NSCLC is pembrolizumab. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Pembrolizumab is usually given into a vein as an intravenous (IV) infusion.
  Researchers want to know if MK-3475A can treat this type of metastatic NSCLC. MK-3475A is pembrolizumab that is given under the skin as a subcutaneous (SC) injection.
  The goal of this trial is to compare what happens to pembrolizumab in a person’s body over time when it is given as an IV infusion or SC injection.

  About 160 people will be in this trial. They will be at least 18 years old and:
  • Have not been treated for metastatic NSCLC
  • Do not have certain types of lung disease

  People will have an equal chance of receiving one of these treatments:
  • SC pembrolizumab, which is given as an SC injection
  • IV pembrolizumab, which is given as an IV infusion
  People will receive treatment once every 6 weeks for about 2 years or until their cancer gets worse, they do not tolerate the treatment, or they or the researchers decide to stop it.
  People may give urine, blood, and tumour samples during the trial. They will also have imaging tests, physical examinations, and answer questions about how they are feeling and their ability to carry out daily tasks. People may be in this trial for up to 5 years.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  24/LO/0614

• Date of REC Opinion

  7 Oct 2024

• REC opinion

  Further Information Favourable Opinion