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Ramucirumab

Phase 3

Gastric Cancer, Adenocarcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment490
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04704934Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)PHASE3 ACTIVE NOT_RECRUITING 490May 21, 2021Aug 31, 2026Jan 12, 2026156 Argentina, Belgium +22
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Study Endpoints
Primary Endpoints
Overall Survival in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Time from date of randomization until death (due to any cause), up to approximately 36 months

Overall survival (OS) is defined as the time from date of randomization until death from any cause.

Secondary Endpoints
Progression-free Survival in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Time from date of randomization until first objective radiographic disease progression or death (due to any cause) whichever occurs first, up to approximately 36 months
Objective Response Rate in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
From start of treatment to date of documented disease progression, up to approximately 36 months
Duration of Response in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel
Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to approximately 36 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Trastuzumab deruxtecanEXPERIMENTALParticipants 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.
Ramucirumab + paclitaxelACTIVE_COMPARATORParticipants 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.
Interventions
NameTypeDescription
Trastuzumab deruxtecanDRUG6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle
RamucirumabDRUG8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
PaclitaxelDRUG80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites156

Inclusion Criteria: * Adults (according to local regulation) and able to provide informed consent for study participation. * Pathologically documented gastric and GEJ adenocarcinoma that has been previously treated in the metastatic setting (unresectable, locally advanced, or metastatic disease). *...

Countries:ArgentinaBelgiumBrazilChileChinaFranceGermanyHong KongHungaryIrelandIsraelItalyJapanPolandPortugalRomaniaRussiaSingaporeSouth KoreaSpainTaiwanTurkey (Türkiye)UkraineUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04704934studyFirstPostDate: changed