DESTINY-PANTUMOUR04
Status
RECRUITING
Phase
Age
18 - 130 Years
Enrollments
100Conditions
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 CancerDrugs
Trastuzumab deruxtecanSummary
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.
Locations
8 locations Found with status Recruiting
Status
- RECRUITING
Central Contacts
- AstraZeneca Clinical Study Information Center
- 1-877-240-9479
- [email protected]
Status
- RECRUITING
Central Contacts
- AstraZeneca Clinical Study Information Center
- 1-877-240-9479
- [email protected]
Status
- RECRUITING
Central Contacts
- AstraZeneca Clinical Study Information Center
- 1-877-240-9479
- [email protected]
Status
- RECRUITING
Central Contacts
- AstraZeneca Clinical Study Information Center
- 1-877-240-9479
- [email protected]
Status
- RECRUITING
Central Contacts
- AstraZeneca Clinical Study Information Center
- 1-877-240-9479
- [email protected]
Status
- RECRUITING
Central Contacts
- AstraZeneca Clinical Study Information Center
- 1-877-240-9479
- [email protected]
Status
- RECRUITING
Central Contacts
- AstraZeneca Clinical Study Information Center
- 1-877-240-9479
- [email protected]
Status
- RECRUITING
Central Contacts
- AstraZeneca Clinical Study Information Center
- 1-877-240-9479
- [email protected]
Eligibility Criteria
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
Study Plan
Trastuzumab deruxtecan
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
DRUG:
Trastuzumab deruxtecanDescription:
Trastuzumab deruxtecan monotherapy
Outcome Measures
Primary Outcome Measures
Real world response rate (rwRR)
Real world duration of response (rwDoR)
Secondary Outcome Measures
Real world time to treatment discontinuation (rwTTD)
Real world time to next treatment (rwTTNT)
Timeline
Last Updated
October 20, 2025Start Date
August 15, 2025Today
March 13, 2026Completion Date ( Estimated )
March 30, 2028
Sponsors of this trial
Lead Sponsor
AstraZeneca
RECRUITING 
18 - 80 Years