NCT06973161

ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors

External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors (ESPERANZA)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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

• Bladder Cancer
• Biliary Tract Cancer
• Cervical Cancer
• Endometrial Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Colorectal Cancer
• Lung Cancer
• Other Tumors

Timeline

• Start date: 2025-06-10
• Primary completion: 2026-03-17
• Completion: 2026-03-17
• First posted: 2025-05-15
• Last updated: 2026-04-08

Locations

27 sites across 12 countries: United States, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Italy, Portugal, Spain, United Kingdom