Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study

INTRODUCTION

  • Org Study ID: D781WR00001
  • Secondary ID: N/A
  • NCT ID: NCT07124000
  • Sponsor: AstraZeneca

BRIEF SUMMARY

This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US

DETAILED DESCRIPTION

This study is a multicenter, hybrid, observational study of approximately 100 prospectively enrolled patients with HER2-positive (IHC 3+) solid tumors in the US initiated on trastuzumab deruxtecan (T-DXd) as per FDA label in routine clinical practice and enrolled at the point of starting treatment with T-DXd. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options will be eligible for inclusion. Patients with breast, colorectal, non-small cell lung cancer (NSCLC), gastric/gastroesophageal junction (GEJ) cancers, and haematological malignancies are not eligible for this study.

Approximately 30 sites will be selected including community oncology practices, hospital systems and academic medical centers (AMCs), with a focus on enrolling a patient population representative of real-world care with the majority of patients from community settings. The primary objective of the study is to assess real world response rate and real world duration of response, and the secondary objective is to assess real world time to treatment discontinuation and real world time to next treatment.

  • Overall Status
    Recruiting
  • Start Date
    September 18, 2025
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Real world response rate (rwRR)

Primary Outcome 1 - Timeframe: Through study completion

Primary Outcome 2 - Measure: Real world duration of response (rwDoR)

Primary Outcome 2 - Timeframe: up to 2.5 years after enrolment

CONDITION

  • Adenocarcinoma (NOS)
  • Anal Cancer
  • Bladder Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Esophageal Cancer
  • Gall Bladder Cancer
  • Gastrointestinal Stromal Tumour
  • Head and Neck Cancer
  • Liver Cancer
  • Melanoma
  • Mouth Cancer
  • Nasopharangeal Cancer
  • Neuroendocrine
  • Gastrointestinal Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Renal Cell Carcinoma
  • Salivary Gland Cancer
  • Sarcoma
  • Small Cell Lung Cancer
  • Testicular Cancer
  • Throat Cancer
  • Thyroid Cancer
  • Urethral Cancer
  • Vaginal Cancer
  • Vulvar Cancer

ELIGIBILITY

Inclusion Criteria:
1. Adults aged ≥18 years

- 2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);

- 3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;

- 4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;

- 5. Patients who are willing and able to provide a signed and dated informed consent.
Exclusion Criteria:
1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;

- 2. Prior T-DXd therapy;

- 3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.

- 4. Patient is participating in a clinical trial at time of enrolment

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: [email protected]

LOCATION

Facility Status Contact
Facility: Research Site
Birmingham, Alabama 35243
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Bullhead City, Arizona 86442
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Casa Grande, Arizona 85122
United States
Status: Recruiting Contact: N/A
Facility: Research Site
San Diego, California 92123
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Boulder, Colorado 80309
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Coral Springs, Florida 33065
United States
Status: Recruiting Contact: N/A
Facility: Research Site
St. Petersburg, Florida 33714
United States
Status: Recruiting Contact: N/A
Facility: Research Site
West Palm Beach, Florida 33401
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Decatur, Illinois 62526
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Topeka, Kansas 66604
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Durham, North Carolina 27708
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Wilson, North Carolina 27893
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Canton, Ohio 44718
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Maumee, Ohio 43537
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Dallas, Texas 75390
United States
Status: Recruiting Contact: N/A