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ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors
NCT06973161 · View on ClinicalTrials.gov ↗
Study Summary
In DESTINY-Pan-Tumor \[DP-02\], DESTINY CRC02 \[DC-02\], and DESTINY-Lung01 \[DL-01\], T-DXd demonstrated tumor response across a broad range of HER2-expressing solid tumors, particularly IHC3+ patients. This study will use real-world data (RWD) to identify IHC3+ patients in the real world who received standard of care (SoC) and compare them with IHC3+ patients who received T-DXd in the referent trials. The tumors included are: non-small cell lung cancer \[NSCLC\], colorectal cancer \[CRC\], endometrial cancer, bladder cancer, epithelial ovarian cancer, cervical cancer, pancreatic cancer, biliary tract cancers, and other tumors. This is a real-world external control arm (ECA) study to generate evidence on the comparative effectiveness of T-DXd versus real-world (RW) SoC in adult patients with HER2 IHC3+ solid tumors who have received prior systemic treatment. HER2 IHC3+ patients who initiated 5.4mg/kg of T-DXd in the referent trials (DP-02, DC-02, and DL-01) will be compared against IHC3+ patients who received RW SoC. This will be a retrospective observational study which will use secondary real-world data and data collected in the 3 aforementioned trials. Objectives: The primary objective of this study is to evaluate the comparative effectiveness with respect to overall survival (OS) for T-DXd vs SoC for patients with HER2 IHC3+ expressing solid tumors in two pooled cohorts: one cohort reflecting the tumors in the three referent trials (referred to as the 'tumor agnostic' cohort), consisting of patients with NSCLC, CRC, endometrial, epithelial ovarian, cervical, pancreatic, biliary tract cancers, and other tumors; and a second cohort reflecting the tumors in the DP-02 trial (referred to as 'pan tumor'), consisting of the same tumors but excluding NSCLC and CRC.
Conditions Studied
Study Locations (20)
Other
- Research Site — Vienna
- Research Site — Liège
- Research Site — London, Ontario
- Research Site — Olomouc
- Research Site — Copenhagen
- Research Site — Caen
- Research Site — Lille
- Research Site — Marseille
- Research Site — Nice
- Research Site — Paris
- Research Site — Saint-Herblain
- Research Site — Berlin
- Research Site — Frankfurt
- Research Site — Heidelberg
- Research Site — W Rzburg
- Research Site — Meldola
- Research Site — Rome
- Research Site — Porto
- Research Site — Barcelona
South Carolina
- Research Site — Spartanburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2025-06-10 |
| Est. Completion | 2026-04-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06973161
The ClinicalTrials.gov registry entry for NCT06973161 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 9 conditions, with Lung Cancer appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06973161 reports 20 study locations spanning 2 distinct geographic areas — top geographies include Other, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06973161 about?
NCT06973161 is a clinical study titled "ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors". In DESTINY-Pan-Tumor \[DP-02\], DESTINY CRC02 \[DC-02\], and DESTINY-Lung01 \[DL-01\], T-DXd demonstrated tumor response across a broad range of HER2-expressing solid tumors, particularly IHC3+ patients. This study will use real-world data (RWD) to identify IHC3+ patients in the real world who rece...
What is the current status of trial NCT06973161?
This trial is currently recruiting. The enrollment target is 105 participants. The study started on 2025-06-10. Estimated completion is 2026-04-30.
What conditions does trial NCT06973161 study?
This clinical trial studies the following conditions: Lung Cancer, Colorectal Cancer, Ovarian Cancer, Pancreatic Cancer, Endometrial Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT06973161?
This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06973161 being conducted?
This trial has 20 study locations across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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