AMAZE-lung

  • Research type

    Research Study

  • Full title

    A multicentre single-arm phase II trial of amivantamab, lazertinib plus bevacizumab in patients with EGFR-mutant advanced NSCLC with progression on previous third generation EGFR TKI

  • IRAS ID

    1006785

  • Contact name

    Monika Hoerrmann

  • Contact email

    monika.hoerrmann@conet-gmbh.de

  • Sponsor organisation

    ETOP IBCSG Partners Foundation

  • Eudract number

    2021-002337-42

  • Clinicaltrials.gov Identifier

    NCT05601973

  • Research summary

    Non-small cell lung cancer (NSCLC) is the most common form of lung cancer. Several factors can cause NSCLC, one of which is a change in the so-called 'EGFR' gene.
    As per current clinical practice, patients with NSCLC with a change in the 'EGFR' gene receive osimertinib (Tagrisso®) or lazertinib, oral drugs that block 'EGFR'.
    Patients with lung cancer generally respond well when they are treated with osimertinib or lazertinib. However, lung cancer often returns within 1-5 years after starting the treatment. Doctors call this a recurrence. Cancer recurrence occurs when the drugs stop working. One possible reason osimertinib or lazertinib stops working is the additional “EGFR” changes that cause the drugs to bind to cell tumour less well.
    The usual therapy for patients whose lung cancer no longer responds to osimertinib or lazertinib is chemotherapy.
    In the AMAZE-lung study, researchers want to see if there is an alternative to chemotherapy for these patients. They want to see if treatment with two antibodies called amivantamab and bevacizumab can effectively stop the growth of lung cancer.
    Amivantamab blocks EGFR and another molecule called MET. Bevacizumab helps block the blood supply to cancer cells. Both drugs may help stop the growth of lung cancer. Amivantamab may also reverse the resistance to lazertinib. Therefore, patients in the AMAZE-lung study will continue to receive lazertinib or begin treatment with lazertinib if they have previously received osimertinib.
    Thus, treatment in the AMAZE-lung study will consist of amivantamab, bevacizumab and lazertinib. Amivantamab and bevacizumab are given as infusions every three weeks. Lazertinib is taken as an oral drug once daily. The treatment continues as long as the lung cancer remains stable. Patients may stop the treatment earlier if they experience side effects that are not tolerable.

  • REC name

    North East - Newcastle & North Tyneside 2 Research Ethics Committee

  • REC reference

    23/NE/0156

  • Date of REC Opinion

    22 Sep 2023

  • REC opinion

    Further Information Favourable Opinion