Phase 3 study of efficacy of MEDI5752 vs Pembro in metastatic NSC Lung Cancer (eVOLVE‑Lung02)

• Research type

  Research Study

• Full title

  A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC).

• IRAS ID

  1007630

• Contact name

  Yehan Wijesinghe

• Contact email

  yehan.wijesinghe1@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2023-000056-38

• Research summary

  Cancer is a disease in which some cells in the body grow uncontrollably; may form tumours; and may spread to other parts of the body (become metastatic). Non-small cell lung cancer (NSCLC) is a type of cancer that starts in the lung. Researchers are looking for a better way to treat metastatic NSCLC (mNSCLC).

  People with mNSCLC are often treated with drugs called immune checkpoint inhibitors (ICIs), which help the immune system fight cancer. Patients can get their tumours tested for a protein called PD-L1 to see if ICIs are a good treatment option. Tumours with low levels of PD-L1 are usually more difficult to treat with ICIs. Pembrolizumab is an ICI given with chemotherapy in people with mNSCLC. The trial drug volrustomig (also called MEDI5752) is an ICI that is designed to work differently from pembrolizumab. In this trial, researchers want to learn if volrustomig could work better than pembrolizumab in participants with mNSCLC who have PD-L1 in less than half of their tumour cells.
  This is a randomized, open-label trial. Randomized means that the treatment each participant receives will be randomly assigned. Open-label means the participants, researchers and other trial staff know which treatment each participant is receiving. There are two treatment arms:

  Standard of care – Pembrolizumab + Chemotherapy
  Experimental – Volrustomig + Chemotherapy

  Participants will receive trial treatment for as long as it is helping, up to a maximum of 2 years.

  Volrustomig, pembrolizumab, and chemotherapy drugs in this trial are given through a needle directly into a vein. The type of chemotherapy each participant receives will depend on information doctors have learned about their tumours.
  This trial will include about 900 participants, all over 18 years of age with mNSCLC and PD-L1 in less than half of their tumor cells.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  23/LO/0733

• Date of REC Opinion

  18 Oct 2023

• REC opinion

  Further Information Favourable Opinion