A study of MK-7684A plus chemoradiotherapy in stage 3 NSCLC

• Research type

  Research Study

• Full title

  Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK- 7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC (KEYVIBE-006)

• IRAS ID

  1010146

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT05298423

• Research summary

  Researchers are looking for new ways to treat people with Non-Small Cell Lung Cancer (NSCLC). Locally advanced NSCLC means that the cancer is in the lungs and in the chest but has not spread to other parts of the body. The cancer cannot be removed with surgery.

  People with locally advanced NSCLC are sometimes treated with chemotherapy, immunotherapy or radiation therapy. Chemotherapy is medicine to destroy cancer cells or stop them from growing. Radiation therapy is a treatment that uses beams of intense energy (like X-rays) to shrink or get rid of tumours. Immunotherapy is a treatment that helps the immune system fight cancer.

  MK-7684A (a coformulation of MK-7684 (vibostolimab) with MK-3475 (pembrolizumab)) and durvalumab are immunotherapies.

  The goal of this study is to learn if people who receive MK-7684A live longer without the cancer getting worse and live longer overall than people who receive durvalumab.

  About 784 adults who have locally advanced NSCLC and have not received treatment for the NSCLC will be in this open-label trial.

  All participants will receive chemotherapy for about 2 months and radiation therapy for about 6 weeks.

  They will also have an equal chance of receiving one of the following treatments:
  • MK-7684A, starting with the first chemotherapy treatment and continuing every 3 weeks for up to about a year
  • Durvalumab, starting after chemotherapy and radiation therapy and continuing every 2 weeks for up to about a year

  The immunotherapy and chemotherapy treatments will be given through a needle in a vein as an intravenous (IV) infusion.

  People may be in this study for up to about 7 years.

  The trial is sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  24/EE/0246

• Date of REC Opinion

  3 Oct 2024

• REC opinion

  Further Information Favourable Opinion