How many clinical trials are studying Datopotamab Deruxtecan?

8 recruiting trials in our tracked data involve Datopotamab Deruxtecan.

What conditions is Datopotamab Deruxtecan being studied for?

In our tracked recruiting trials, Datopotamab Deruxtecan is being studied in trials for Breast Cancer, Lung Cancer, Non Small Cell Lung Cancer.

Datopotamab Deruxtecan: clinical trials recruiting now

Q: Is Datopotamab Deruxtecan FDA-approved?

Yes. According to the FDA drug label available through openFDA, Datopotamab Deruxtecan is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Datopotamab Deruxtecan appears in the FDA drug-label database. Marketed as DATROWAY.

FDA-approved use

DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy [see Clinical Studies (14.2) ] . ( 1.2 ) adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. ( 1.3 ) 1.1 Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) DATROWAY is indicated for t…

FDA label via openFDA

Phase breakdown

Phase 2 5 Phase 3 2 Not applicable 1

Conditions being studied

Condition	Trials
Breast Cancer · Datopotamab Deruxtecan for Breast Cancer	5
Lung Cancer · Datopotamab Deruxtecan for Lung Cancer	3
Non Small Cell Lung Cancer · Datopotamab Deruxtecan for Non Small Cell Lung Cancer	3
HER2-negative Breast Cancer	2
Angiosarcoma	1
Brain Metastases	1
Breast Cancer Female	1
Breast Cancer Stage IV	1
Breast Neoplasms	1
Breast Tumors	1
Drug-Related Side Effects and Adverse Reactions	1
ER Positive Breast Cancer	1
ER-negative Breast Cancer	1
Early-stage Breast Cancer	1
HER2 Negative Breast Carcinoma	1

Recruiting trials involving Datopotamab Deruxtecan

A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)
NCT06822543 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 13 locations
DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
NCT06176261 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 3 locations
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
NCT01042379 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 42 locations
Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response
NCT07582887 · Phase: Not specified · Ages: 18 Years and older · Sex: All (male and female) · 1 location
PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
NCT07069595 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
NCT05866432 · Phase: Phase 2 · Ages: 18 Years to 100 Years · Sex: All (male and female) · 1 location
Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT06350097 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 167 locations
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
NCT06357533 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 287 locations

Common questions

Is Datopotamab Deruxtecan FDA-approved?

Yes, marketed as DATROWAY.

How many recruiting trials involve Datopotamab Deruxtecan?

8 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.