Ph 3 adjuvant pembro +/- V940 after neoadjuvant pembro+chemo in NSCLC

• Research type

  Research Study

• Full title

  A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)

• IRAS ID

  1010272

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06623422

• Research summary

  Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer and can sometimes be removed with surgery. Researchers want to know if giving V940 and pembrolizumab, the study medicines, after surgery can help prevent the cancer from coming back in people with NSCLC whose tumours did not respond completely to neoadjuvant (pre surgical) treatment. V940 is designed to help a person’s immune system attack their specific cancer. Pembrolizumab is an immunotherapy.
  The goal of this study is to learn if participants who receive V940 and pembrolizumab after surgery are cancer free longer than participants who receive placebo and pembrolizumab.
  About 680 participants with NSCLC will be in this study. They will be at least 18 years old and:
  • Have NSCLC that can be removed with surgery
  • Can receive pembrolizumab and chemotherapy
  • Have not had prior treatment for NSCLC
  Participants will have surgery to remove the NSCLC and will also receive 3 of these treatments:
  • Chemotherapy of the researcher’s choice before surgery
  • Pembrolizumab every 3 weeks before surgery and every 6 weeks after surgery
  • V940 every 3 weeks after surgery
  • Placebo every 3 weeks after surgery

  Participants may be in this study for about 12 years. This study has 2 parts:
  Part 1 (before surgery): Participants will receive pembrolizumab and chemotherapy for 3 months and then have surgery to remove the NSCLC.
  Part 2 (after surgery): Participants who have signs of cancer cells in their tissues removed during surgery will have an equal chance to receive either:
  • V940 for about 4 months and pembrolizumab for about 10 months
  • Placebo for about 4 months and pembrolizumab for about 10 months
  Neither the participants nor the researchers will know if a person receiving V940 or placebo (double-blind study).

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  24/SC/0239

• Date of REC Opinion

  16 Oct 2024

• REC opinion

  Further Information Favourable Opinion