DS-8201a in participants with HER2+ Cancer after disease progression

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study of Trastuzumab Deruxtecan in Subjects with HER2 Positive Metastatic and/or Unresectable Gastric or Gastro Esophageal Junction (GEJ) Adenocarcinoma Subjects who have Progressed on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

• IRAS ID

  295535

• Contact name

  Elizabeth Smyth

• Contact email

  Elizabeth.Smyth@addenbrookes.nhs.uk

• Sponsor organisation

  Daiichi Sankyo, Inc.

• Eudract number

  2020-004559-34

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT04704934

• Clinicaltrials.gov Identifier

  136179, IND

• Duration of Study in the UK

  3 years, 2 months, 13 days

• Research summary

  Gastric cancer (GC) is diagnosed at an advanced stage in approximately 50% of patients, when it has a poor outcome.

  The study drug trastuzumab deruxtecan (T-DXd) is being developed by Daiichi Sankyo, Inc. and AstraZeneca. The main purpose of this study is to gather information about T-DXd in participants with human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-oesophageal junction (GEJ) adenocarcinoma that progressed on or after a trastuzumab-containing regimen. HER2-positive gastric cancer or gastro-oesophageal junction (GEJ) adenocarcinoma is a cancer that tests positive for a protein called HER2, which promotes the growth of cancer cells

  T-DXd has been approved in certain countries for HER2 positive breast and gastric cancer but it has not been approved for this disease type i.e., gastric cancer patients who have progressed on or after a trastuzumab containing regimen.

  Ramucirumab (Ram) and paclitaxel (PTX) are the other drugs to be used in this study. The combination (Ram + PTX) is considered standard of care in many of countries for the treatment of this disease.

  There is no established targeted therapy for HER2-positive advanced GC in the second-line setting after progression on first-line treatment with a trastuzumab-containing regimen. Preferred second-line treatments for metastatic or locally advanced GC include Ram + PTX (as single agents or in combination) or other chemotherapeutic agents.

  The study plans to have about 490 participants. Participants will be randomly assigned with a 50% chance (similar to flipping a coin) to one of the following dose groups:
  • Treatment Group 1: T-DXd 6.4 mg/kg
  • Treatment Group 2: Ram 8 mg/kg + PTX 80 mg/m2

  The study will be divided into 4 periods Tissue Screening, Screening, Treatment, and Follow-up (which includes Long-Term Follow-Up) with an average study duration for the Tissue Screening, Screening, and Treatment periods of approximately 40 weeks.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  21/EM/0109

• Date of REC Opinion

  23 Jun 2021

• REC opinion

  Further Information Favourable Opinion