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Trial · NCT04379596

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

NCT04379596, Phase 2, Active not recruiting, AstraZeneca

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03). Trials, record NCT04379596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04379596

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
NCT number
NCT04379596
Status
Active not recruiting
Phases
Phase 2
Enrollment
452 participants, actual
Lead sponsor
AstraZeneca
Conditions
Gastric Cancer
Interventions
Fluorouracil (5-FU), Capecitabine, Durvalumab, Oxaliplatin, Trastuzumab, Trastuzumab deruxtecan, Cisplatin, Pembrolizumab, Volrustomig, Rilvegostomig
First posted
2020-05-07
Last updated
2026-08-28
Other registries' IDs
eudract:2019-004483-22

Source ClinicalTrials.gov

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPart 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0Safety will be assessed up to the follow-up period, approximately 24 months.Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0
PrimaryPart 1: Ocurrence of dose-limiting toxicities (DLTs)Safety will be assessed up to the follow-up period, approximately 24 months.Occurrence of dose limiting toxicities
PrimaryPart 1: Changes from baseline in laboratory parametersSafety will be assessed up to the follow-up period, approximately 24 months.Changes in laboratory parameters (every in appropriate units) compared to baseline results.
PrimaryPart 1: Changes from baseline in vital signsSafety will be assessed up to the follow-up period, approximately 24 months.Changes in vital signs results compared to baseline results.
PrimaryPart 1: Changes from baseline in electrocardiogram (ECG) resultsSafety will be assessed up to the follow-up period, approximately 24 months.Changes in ECG results compared to baseline results.
PrimaryPart 2, Part 3, Part 4 and Part 5: Endpoint assessed by Investigator per RECIST v1.1: Confirmed Objective Response Rate (ORR)(Endpoint: ORR) Efficacy will be assessed at an average of approximately 12 monthsConfirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
SecondaryPart 1: Objective Response Rate (ORR)Efficacy will be assessed at an average of approximately 12 monthsConfirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
SecondaryPart 2, Part 3, Part 4 and Part 5: Occurrence of adverse events (AEs) and serious adverse events (SAEs)Safety will be assessed up to follow-up period, approximately 24 monthsOccurrence of AEs and SAEs graded according to NCI CTCAE v5.0
SecondaryPart 2, Part 3, Part 4 and Part 5: Changes from baseline in laboratory parametersSafety will be assessed up to follow-up period, approximately 24 monthsChanges in laboratory parameters (every in appropriate units) compared to baseline results.
SecondaryPart 2, Part 3, Part 4 and Part 5: Changes from baseline in vital signsSafety will be assessed up to follow-up period, approximately 24 monthsChanges in vital signs results compared to baseline results.

Outcomes0

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.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
40341124DERIVED

Source PubMed

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT04379596

GET https://conductscience.org/api/trials/v1/NCT04379596/registered?page=2