Trial · NCT06764875
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
NCT06764875, Phase 3, Recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer. Trials, record NCT06764875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06764875
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
- NCT number
- NCT06764875
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 840 participants, estimated
- Lead sponsor
- AstraZeneca
- Conditions
- HER2-positive Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Interventions
- Rilvegostomig, Trastuzumab deruxtecan, Trastuzumab, Pembrolizumab, 5-fluorouracil, Capecitabine, Cisplatin, Oxaliplatin
- First posted
- 2025-01-09
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival (PFS) | Up to approximately 6 years | PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. |
| Primary | Overall Survival (OS) | Up to approximately 6 years | OS is defined as time from randomization until the date of death due to any cause. |
| Secondary | Objective Response Rate (ORR) | Up to approximately 6 years | ORR according to RECIST v1.1. ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR). |
| Secondary | Duration of Response (DoR) | Up to approximately 6 years | DoR according to RECIST v1.1. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1 or death due to any cause. |
| Secondary | Proportion of all randomized participants alive and progression-free at 6 months (PFS6) | Up to 6 months | Proportion of all randomized participants alive and progression-free at 6 months calculated for progression. |
| Secondary | Proportion of all randomized participants alive and progression-free at 12 months (PFS12) | Up to 12 months | Proportion of all randomized participants alive and progression-free at 12 months calculated for progression. |
| Secondary | Time to second progression or death (PFS2) | Up to approximately 6 years | PFS2 is defined as the time from randomization to the earliest of the progression event (following the initial progression), after the first subsequent therapy, or death, where the first objective progression includes progression occurring after 2 missed visits. |
| Secondary | Occurrence of adverse events (AEs) and serious adverse events (SAEs) | Up to approximately 6 years | Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0. |
| Secondary | Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum | Up to approximately 6 years | Concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, fluoropyrimidine, and capecitabine in serum or plasma. |
| Secondary | Immunogenicity of rilvegostomig and T-DXd assessed by the presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd | Up to approximately 6 years | Presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd (confirmatory results: titers and neutralizing antibodies for confirmed positive samples). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06764875
GET https://conductscience.org/api/trials/v1/NCT06764875/registered