TROPION-Lung10

• Research type

  Research Study

• Full title

  A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig (AZD2936) or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)

• IRAS ID

  1009084

• Contact name

• Contact email

  UKRegulatoryAffairs@astrazeneca.com

• Sponsor organisation

  Astrazeneca AB

• Clinicaltrials.gov Identifier

  NCT06357533

• Research summary

  Researchers are looking for a better way to treat advanced non small cell lung carcinoma (NSCLC). In people with NSCLC, the body is unable to control the growth of some cells, and these extra cells form tumours. Advanced NSCLC occurs when cancer has grown and spread until it cannot be treated with surgery.

  People with advanced NSCLC are often tested to see if their tumours have a protein called PD-L1. NSCLC with high levels of PD-L1 is often treated with a type of drug called an immune checkpoint inhibitor (CPI). One CPI often used for treatment is pembrolizumab.
  One of the trial drugs, rilvegostomig, is a CPI designed differently from pembrolizumab, and targets PD-L1 and another protein called TIGIT at the same time. The other trial drug, Dato-DXd, is designed to target another protein called TROP2. TROP2 is found at high levels on the surface of some cancer cells. Researchers think that Dato-DXd with rilvegostomig could work better than pembrolizumab for treating people with advanced NSCLC and with high levels of PD-L1. Researchers would also like to review how well this treatment works for participants with TROP2 on their cancer cells.
  This is a randomised, open-label trial. Randomized means that the treatment each participant receives will be randomly assigned. Open-label means the participants, trial doctors and other trial staff know which treatment each participant is receiving. There are three treatment arms:

  Experimental – Rilvegostomig
  Experimental – Rilvegostomig + Dato-DXd
  Control – Pembrolizumab

  Rilvegostomig, Dato-DXd and pembrolizumab are all given through a needle directly into a vein.
  Participants will receive trial treatment for as long as it is helping them. Participants who are randomized to pembrolizumab will receive treatment for up to 2 years.

  This trial will include about 675 participants, all over 18 years of age.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  24/LO/0011

• Date of REC Opinion

  6 Mar 2024

• REC opinion

  Further Information Favourable Opinion