ETOP 25-23 ADOPT-lung

  • Research type

    Research Study

  • Full title

    An international, multicentre, open-label randomised phase III trial to evaluate the benefit of adding adjuvant durvalumab after neoadjuvant chemotherapy plus durvalumab in patients with stage IIB-IIIB (N2) resectable NSCLC

  • IRAS ID

    1009898

  • Contact name

    Monika Hoerrmann

  • Contact email

    monika.hoerrmann@conet-gmbh.de

  • Sponsor organisation

    ETOP IBCSG Partners Foundation

  • Clinicaltrials.gov Identifier

    NCT06284317

  • Research summary

    Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. The decision about treatment depends on the size of the tumour and how far it has spread to other parts of the body. Surgery is the standard treatment for people with early-stage NSCLC.
    People with early-stage NSCLC may have neoadjuvant therapy, including chemotherapy and immunotherapy, before surgery. The aim of neoadjuvant treatment is to shrink the tumour and make surgery more effective.
    If, after neoadjuvant treatment, there are no signs of cancer cells left in the tissue removed during surgery, this is called a pathological complete response.
    After surgery, adjuvant therapy, including chemotherapy and immunotherapy, is given to eradicate any remaining cancer cells and minimise the risk of recurrence.
    Durvalumab (Imfinzi®) is an immunotherapy drug. It is an antibody that stimulates the body’s own immune system to fight against cancer cells. Durvalumab seeks out cancer cells and attaches itself to them. The immune system then recognises these cancer cells and destroys them.
    In a recent study of patients with early-stage NSCLC, durvalumab was shown to be effective when given both before and after surgery. However, the specific effect relates to the treatment before or after surgery remains unclear.
    The ADOPT-lung study is investigating whether adjuvant treatment with durvalumab is needed after surgery.
    Before surgery, patients will receive neoadjuvant treatment with chemotherapy and durvalumab. After surgery, patients will receive adjuvant treatment with durvalumab for one year or no further treatment.

  • REC name

    Wales REC 2

  • REC reference

    25/WA/0006

  • Date of REC Opinion

    30 Jan 2025

  • REC opinion

    Further Information Favourable Opinion