Could T-DXd outperform standard care for multiple HER2-Positive cancers? new study investigates
NCT ID NCT06973161
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether the drug T-DXd works better than standard treatments for people with several types of HER2-positive solid tumors. Researchers will compare data from previous T-DXd trials with real-world medical records of patients who received standard care. The goal is to see if T-DXd helps patients live longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trastuzumab deruxtecan (T-DXd)
- What this could lead to
- If successful, this could provide stronger evidence that T-DXd is more effective than standard treatments for several HER2-positive cancers.
- What could go wrong
- This is a retrospective study using existing data, not a new trial. Results may be less reliable than a randomized controlled trial, and differences in patient groups could skew comparisons.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
140 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
-
Mar 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population of interest is adult patients with HER2 IHC3+ unresectable and/or metastatic disease falling within the indications of interest. All IHC3+ patients who initiated 5.4 mg/kg of T-DXd in DP-02, DC-02, or DL-01 for each indication will be included in the T-Dxd arm of this study. To identify RW SoC patients for each indication, relevant eligibility criteria from the corresponding referent trial will be applied and modified for the RW setting where required.
- Ages
-
18 to 130 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (for the ECA): Male or female patients aged 18 years or older at the time of locally advanced, unresectable or metastatic disease diagnosis. Patients diagnosed with one of the following malignancies: Locally advanced, unresectable or metastatic colorectal adenocarcinoma, biliary tract, bladder (urothelial), cervical, endometrial, epithelial ovarian, pancreatic, or other solid tumors, or unresectable and/or metastatic non-squamous NSCLC. Patients may be included on the basis of de-novo locally advanced, unresectable or metastatic disease diagnosis or progression from initial diagnosis at earlier stages. Patients must have received at least one line of prior systemic anti-cancer therapy (SACT) therapy in the advanced/ unresectable/ metastatic setting (i.e. excluding adjuvant/ neoadjuvant SACT) prior to index. Index date (start of 2nd or later line SoC systemic anti-cancer therapy (SACT) treatment) for advanced disease occurring between January 2017 and December 2022. \[CRC patients only\] Prior treatment at index with at least one of the following in prior lines of therapy: Fluoropyrimidine, oxaliplatin, and irinotecan Anti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type Anti-vascular endothelial growth factor (VEGF) treatment Anti-programmed death-ligand 1 (PD-\[L\]-1) therapy if tumor is microsatellite instable (MSI)-high/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high \[CRC patients only\] BRAF wild-type cancer and confirmed RAS status (either mutant or wild type) identified through testing of the primary tumor or metastatic site at any time following initial diagnosis. IHC3+ HER2-expression confirmed through testing of tumor samples taken in the advanced/ recurrent/ metastatic disease stage. The sample taken closest in time prior to the or at start of the index line of therapy should be used to confirm IHC3+ HER2 status. Positive IHC3+ tests may be the result of testing at the time of sampling by the sites or retrospective testing based on archival tumor samples ECOG of 0 or 1 (or Karnofsky score of ≥ 70%8), or missing performance status based on most recently recorded information prior to or at index date. Patients without recorded history of liver disease, leukaemia, aplastic anaemia or haemophilia at index date. Patients known to have died must have a complete recorded date of death. Exclusion Criteria (for the ECA): Record of other primary malignancies (except non-melanoma skin cancer) at any time prior to or after index. Record of spinal cord compression prior to or at index or active CNS metastases at index (with active CNS metastases determined per physician judgment OR receipt of radiotherapy directed at CNS metastases within 6 months prior to index). Record of myocardial infarction within 6 months prior to index date or congestive heart failure at any time prior to or at index date. Record of lung-specific intercurrent clinically significant illness based on physician judgement prior to or at index date. History of (non-infectious) ILD/ pneumonitis prior to or at index. Record of autoimmune, connective tissue or inflammatory disorders prior to or at index date. Record of complete pneumonectomy prior to or at index date. Presence of systemic infection at index date. Record of HIV prior to or at index date, or active Hep B or Hep C infection at index date. Treatment with T-DXd or DXd-containing ADC at any time prior to or at index. Record of pregnancy at or at any time following advanced/ unresectable/ metastatic disease diagnosis. Treatment as part of a clinical trial at any time prior to or at index. \[Pan-tumor patients only\] Patients with a record of pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART) at index. \[Colorectal patients only\] Patients with record of leptomeningeal carcinomatosis prior to or at index. \[NSCLC patients only\] Treatment with a HER2-targeted therapy (except for pan-HER class tyrosine kinase inhibitors) at any time prior to or at index. \[NSCLC patients only\] Record of unstable angina at any time prior to or at index date.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Biliary tract cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Spartanburg, South Carolina, 29303, United States
-
Research Site
Houston, Texas, 77030, United States
-
Research Site
Vienna, Austria
-
Research Site
Liège, Belgium
-
Research Site
London, Ontario, N6A 5A5, Canada
-
Research Site
Olomouc, Czechia
-
Research Site
Copenhagen, Denmark
-
Research Site
Caen, France
-
Research Site
Lille, France
-
Research Site
Marseille, France
-
Research Site
Nice, France
-
Research Site
Paris, France
-
Research Site
Saint-Herblain, France
-
Research Site
Berlin, Germany
-
Research Site
Essen, Germany
-
Research Site
Frankfurt, Germany
-
Research Site
Heidelberg, Germany
-
Research Site
Würzburg, Germany
-
Research Site
Meldola, Italy
-
Research Site
Rome, Italy
-
Research Site
Porto, Portugal
-
Research Site
Barcelona, Spain
-
Research Site
Madrid, Spain
-
Research Site
Pamplona, Spain
-
Research Site
Valencia, Spain
-
Research Site
Leeds, United Kingdom
-
Research Site
London, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Surgeons could freeze lung tumors from miles away using 5G robots
- Can hormone pills replace chemo for aggressive endometrial cancer?
- Dutch bladder cancer cohort aims to map survival and recurrence
- Second try: pumping chemo straight into the liver for tumors that outsmarted standard treatment
- Can AI make lung cancer scans easier to read?
- Can a Three-Drug combo crack pancreatic Cancer's defenses?