Trial · NCT07291037
Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
NCT07291037, Phase 3, Recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations. Trials, record NCT07291037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07291037
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
- NCT number
- NCT07291037
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 400 participants, estimated
- Lead sponsor
- AstraZeneca
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Interventions
- Datopotamab deruxtecan (Dato-DXd), Docetaxel
- First posted
- 2025-12-18
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) | Approximately 2.5 years | PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR), or death due to any cause. |
| Primary | Overall survival (OS) | Approximately 3.5 years | OS is defined as the time from randomization until the date of death due to any cause. |
| Secondary | Objective response rate (ORR) | Approximately 2.5 years | ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). |
| Secondary | Duration of response (DoR) | Approximately 2.5 years | DoR is defined as the time from the date of first documented response until the date of documented progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR) or death due to any cause. |
| Secondary | Time to second progression or death (PFS2) | Approximately 2.5 years | PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after first subsequent therapy, or death. The date of the second progression will be recorded by the Investigator in the electronic Case Report Form (eCRF) and defined according to local standard clinical practice based on radiological or clinical progression. |
| Secondary | Participant-reported lung cancer symptoms of non-small cell lung cancer (NSCLC) | Approximately 2.5 years | Time to deterioration (TTD) in pulmonary symptoms (dyspnoea, cough, and chest pain). TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as change from baseline that reaches an meaningful change threshold (MCT). |
| Secondary | Participant-reported physical functioning | Approximately 2.5 years | Time to deterioration (TTD) in physical functioning. TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold (MCT). |
| Secondary | Participant-reported global health status (GHS)/quality of life (QoL) | Approximately 2.5 years | Time to deterioration (TTD) in GHS/QoL. TTD is defined as time from the date of randomisation to the date of first deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold (MCT) |
| Secondary | Diagnostic development and biomarker assay concordance analysis | Approximately 2.5 years | Evaluate the relationship between TROP2 NMR status at a defined cutoff and efficacy endpoints, as determined by the diagnostic device. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07291037
GET https://conductscience.org/api/trials/v1/NCT07291037/registered