A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies (PROSPERITY)

Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study ID
NCT05993234
Status
Recruiting
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Conditions

  • HER2-positive Advanced Gastric Cancer
  • HER2-positive Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan — DRUG
    This is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice. T-DXd to be administered according to the SmPC. Conventional therapy (eg. platinum-fluoropyrimidine doublet chemotherapy, nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and pembrolizumab monotherapy) to be administered according to the SmPC.

Study Details

Trastuzumab deruxtecan (T-DXD) as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. This study will assess the effectiveness of T-DXd, patient demographic and clinical characteristics, and treatment patterns in patients with advanced HER2-positive advanced gastric or GEJ adenocarcinoma.

Key Dates

Start date
Dec 5, 2023
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
257 participants (estimated)

Arms

  • Arm: Trastuzumab deruxtecan (T-DXd)
    Participants with HER2-positive gastric or gastroesophageal junction adenocarcinoma who will be treated with trastuzumab deruxtecan and part of the enrolled participants will receive conventional therapy. The participants on conventional therapy will be analyzed for exploratory purposes only.

Primary Outcome Measure

Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma [ Time Frame: Baseline up to approximately 2 years ]

Central Contacts