AVANZAR

• Research type

  Research Study

• Full title

  A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR)

• IRAS ID

  1006036

• Contact name

  Abhijit Nair

• Sponsor organisation

  AstraZeneca UK Ltd

• Eudract number

  2021-004606-21

• Clinicaltrials.gov Identifier

  NCT05687266

• Research summary

  The purpose of this study is to learn more about whether an investigational drug called datopotamab deruxtecan (Dato-DXd) given in combination with two approved medicines (durvalumab and carboplatin) will be safe and effective for the treatment of locally-advanced or metastatic non-small cell lung cancer (NSCLC). This study will compare the experimental treatment with an approved treatment called pembrolizumab, given in combination with platinum-based chemotherapy. Dato-DXd is a new type of anti-cancer drug called an antibody drug conjugate (ADC) that targets cancer cells expressing high-levels of a specific molecule. Dato-DXd is made up of two parts linked together. One part is a protein called a monoclonal antibody (datopotamab or Dato) that recognizes and attaches to a specific protein found on the surface of cancer cells called trophoblast cell surface protein 2 (TROP2). Another part contains a chemotherapy-like molecule called deruxtecan (DXd). When Dato-DXd binds to a TROP2 protein on a cancer cell, the link holding the two parts together breaks and DXd is released into the cancer cell damaging or killing it.
  Dato-DXd is given by intravenous (IV) infusion once every 3 weeks.
  Patients meeting the screening criteria will be randomly assigned to one of two treatment arms, Dato-DXd+durvalumab+carboplatin (experimental treatment) or pembrolizumab+platinum-based chemotherapy (comparator treatment). Patients have a 50% (1 in 2) chance of receiving the experimental treatment versus the comparator treatment. Approximately 1000 patients will take part in approximately 24 countries in North and South America, Europe and Asia. This study involves screening, treatment, and follow-up (after study treatment discontinuation) periods. Patients who decide to take part in the study will attend regular clinic visits for drug infusions, physical exams, blood/urine and other safety tests, and imaging scans for tumour assessments. The study is planned to go on for about 5 years.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  22/NW/0322

• Date of REC Opinion

  18 Nov 2022

• REC opinion

  Further Information Favourable Opinion