Pembro With or Without MK-2870 in Metastatic Squamous NSCLC

• Research type

  Research Study

• Full title

  A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer

• IRAS ID

  1009838

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC). Current treatments for metastatic NSCLC are chemotherapy and immunotherapy.

  Pembrolizumab and MK-2870 are the trial medicines. MK-2870 attaches to specific targets on cancer cells and delivers treatment to destroy those cells.

  Researchers want to learn if adding MK-2870 to pembrolizumab can treat metastatic NSCLC. The goal of this trial is to learn if people who receive pembrolizumab with MK-2870 live longer overall compared to pembrolizumab alone.

  About 851 people, aged at least 18 years old, will be in this trial and:
  • Have metastatic squamous NSCLC
  • Have not received treatments for metastatic NSCLC
  • Do not have another type of lung cancer

  This trial has 2 parts:
  Part 1 (Induction therapy): Everyone will receive pembrolizumab and chemotherapy for about 3 months as their first treatment.
  Part 2 (Maintenance therapy): People who don’t have the cancer get worse after completing induction therapy will receive more treatment. In Part 2, people will have an equal chance to receive:
  • Pembrolizumab with MK-2870 OR
  • Pembrolizumab alone

  People will receive 2 or all of these treatments through a needle into a vein (intravenous infusion):
  • Pembrolizumab, given every 3 weeks during Part 1 and every 6 weeks during Part 2
  • MK-2870, given every 2 weeks during Part 2
  • Chemotherapy, given every 1 or 3 weeks during Part 1

  People will receive pembrolizumab for up to about 2 years.
  People will receive MK-2870 until the cancer gets worse or they don’t tolerate it.

  Both the people in the trial and the researcher will know which trial treatment a person is getting. During the trial, people will give urine, blood, and tumour samples, have imaging tests and physical examinations, and answer questions.

  A person may be in this trial for about 5 years.

• REC name

  North East - York Research Ethics Committee

• REC reference

  24/NE/0094

• Date of REC Opinion

  30 Jul 2024

• REC opinion

  Further Information Favourable Opinion