A study of SGN-B6A versus docetaxel in previously treated non-small cell lung cancer

• Research type

  Research Study

• Full title

  A randomized, phase 3, open-label study to evaluate SGN-B6A compared with docetaxel in adult subjects with previously treated non-small cell lung cancer

• IRAS ID

  1008246

• Contact name

  Scott Knowles

• Contact email

  EU-Regulatory@seagen.com

• Sponsor organisation

  Seagen Inc.

• Clinicaltrials.gov Identifier

  NCT06012435

• Research summary

  This study is being carried out to test if SGN-B6A (investigational drug) is safe and effective for the treatment of non-small cell lung cancer (NSCLC).
  SGN-B6A is a type of drug called an antibody drug conjugate (ADC).
  ADCs usually have 2 parts – antibody and drug. The antibody part was designed to find the cancer cell so that the drug part can kill the cancer cell.
  Participants must have NSCLC and meet the screening criteria to join this study. Participants who join this study will have a 50% chance to be given either SGN-B6A or docetaxel.
  Both the participant and the study team will know which drug is being given to the participant.
  Participants who are given SGN-B6A will get SGN-B6A on Day 1 and Day 8 of every 21-day cycle.
  Participants who are given docetaxel will get docetaxel on Day 1 of every 21-day cycle.
  Participants will complete several tests while taking the study drug, which includes questionnaires, physical exams, urine samples, blood samples, electrocardiograms, and imaging scans to measure the cancer such as magnetic resonance imaging scans, computerized tomography scans, and bone scans.

  After the patient has stopped taking the drug, the study team will follow up with the participant for other NSCLC therapies and participant’s status.
  The study will be conducted for approximately 5 years, and approximately 560 participants will take part in this study at 210 locations across 28 countries. This study is sponsored by Seagen Inc.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  24/NE/0039

• Date of REC Opinion

  13 Mar 2024

• REC opinion

  Further Information Favourable Opinion