Pembro With or Without MK-2870 in Resectable NSCLC not Achieving pCR

• Research type

  Research Study

• Full title

  A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery

• IRAS ID

  1009210

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  This trial is testing MK-2870 given in combination with pembrolizumab (MK-2870 plus pembro) after surgery in people with newly diagnosed non-small cell lung cancer (NSCLC).

  MK-2870 is experimental. It has not been approved to be given alone, or in combination with pembro, to treat any disease. Pembro (also called KEYTRUDA®) has been approved by certain health authorities for the treatment of various cancers, including NSCLC in the UK.

  Participants can be in the trial if:
  • Aged at least 18 years old
  • Have newly diagnosed NSCLC that can be removed with surgery
  • Are able to undergo surgery
  • Have no prior treatment for NSCLC. However, if the participant has already received pembrolizumab with chemotherapy (chemo) followed by surgery, they may still be able to join the trial.
  • Able to receive treatment with immunotherapy in combination with chemo

  About 1,418 people will start treatment before surgery. About 780 people will get trial treatment after surgery.

  If the participant didn’t have surgery for NSCLC before beginning the trial, they’ll receive pembro and chemo for up to 12 weeks. The type of chemo the participant receives depends on the type of NSCLC. Participants may have surgery after followed by radiotherapy for 6 weeks.

  If the participant had surgery for NSCLC before beginning the trial, they’ll get the trial treatment.

  Participants will have an equal chance of receiving either:
  • MK-2870 plus pembro
  • Pembro alone

  MK-2870 is given 1 time every 2 weeks and pembro is given 1 time every 6 weeks. MK-2870 and pembro are given through a needle into a vein as an intravenous infusion.

  During the trial, participants may give urine/blood samples, have tumour and imaging tests, physical examinations, answer questions about how they’re feeling and their ability to carry out daily tasks. A participant may be in this trial for about 5-10 years.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  24/NE/0063

• Date of REC Opinion

  28 Mar 2024

• REC opinion

  Further Information Favourable Opinion