Duravelo 4

• Research type

  Research Study

• Full title

  Phase 2 Study of Zelenectide Pevedotin in Participants with Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer (Duravelo-4)

• IRAS ID

  1012123

• Contact name

  BicycleTx Limited Medical Affairs -

• Contact email

  medinfo@bicycletx.com

• Sponsor organisation

  BicycleTx Limited

• Clinicaltrials.gov Identifier

  NCT06933329

• Research summary

  Zelenectide pevedotin is a type of medication called a ‘bicycle drug conjugate’ which is designed to target the protein, Nectin-4. High levels of Nectin-4 protein have been found on the surface of tumour cells in lung cancer with NECTIN4 gene amplification. This medication is expected to kill tumour cells that have a large quantity of this protein.
  This study primarily aims to determine if zelenectide pevedotin works against non-squamous/squamous non-small cell lung cancer (NSCLC). This is a group of patients with poor prognosis with an expected median survival of 10 months.
  Approximately up to 73 participants (48 participants with non-squamous NSCLC and 25 participants with squamous NSCLC) with NECTIN4 amplified cancers will take part in this study at approximately 40 sites in approximately 6 countries.
  Participants will receive zelenectide pevedotin on day 1 and 8 of each 21-day cycle as an intravenous (IV) infusion into a vein.
  There are 5 stages to this study: pre-screening, screening, treatment period, end of treatment and follow-up. The follow-up period includes a short-term safety follow-up period followed by a long-term follow-up period . A safety follow-up visit will occur approximately 30 days after the last study medication treatment. The long-term follow-up period includes visits/calls approximately every 3 months.

  This study involves procedures such as: physical examinations; collection of vital signs; eye examinations; electrocardiograms (ECGs); pulmonary function tests; collection of blood, urine and tumour tissue samples; radiological scans (such as CT, MRI, bone scan or PET scan).
  Not all participants will stay in the study for the same amount of time. The number of treatment cycles received will depend on how well patients tolerate the study medications, if they are responding to the study medication and their overall condition. Potentially patients could be in this study for up to 1.5 years.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  25/SC/0175

• Date of REC Opinion

  4 Jul 2025

• REC opinion

  Further Information Favourable Opinion