DESTINY-PANTUMOUR04 (DP-04)

AstraZeneca

Status: Enrolling

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

Treatments: Drug: Trastuzumab deruxtecan

Study type: Observational

Funder types: Industry

Identifiers

NCT07124000

D781WR00001

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Trastuzumab deruxtecan

Description:

Patients with locally advanced, unresectable, or metastatic HER-2 positive (IHC3+) solid tumours for whom a clinician decision has been made for treatment with T-DXd as part of routine clinical practice and in line with the FDA label

Treatment:

Drug: Trastuzumab deruxtecan