Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

Sponsor
Daiichi Sankyo
Study ID
NCT04704934
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Gastric Cancer, Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Trastuzumab deruxtecan — DRUG
    6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle
  • Ramucirumab — DRUG
    8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
  • Paclitaxel — DRUG
    80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle

Study Details

This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy.

Key Dates

Start date
May 21, 2021
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
490 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab deruxtecan
    Participants who will be randomized to receive a 6.4 mg/kg intravenous (IV) dose of trastuzumab deruxtecan once every 3 weeks on Day 1 of each 21-day cycle.
  • Active Comparator: Ramucirumab + paclitaxel
    Participants who will be randomized to receive a 8 mg/kg IV dose of ramucirumab on Days 1 and 15 in combination with 80 mg/m\^2 IV dose of paclitaxel on Days 1, 8, and 15 of a 28-day cycle.

Primary Outcome Measure

Overall Survival in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel [ Time Frame: Time from date of randomization until death (due to any cause), up to approximately 36 months ]

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