ESPERANZA: T-DXd Pan-tumor ECA Study

Not yet recruiting

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

• Registration Number: NCT06973161
• Lead Sponsor: AstraZeneca

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-23
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Study Start: 2025-05-30
• Primary Completion: 2025-11-03
• Study Completion: 2025-11-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	Anticipated to be approximately 11 to 17 months	Time from the date of first dose of treatment until the date of death due to any cause.