Trial · NCT06417814
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free Survival (PFS) | Up to 2.5 years | PFS is defined as the time from randomization to Blinded Independent Central Review (BICR)-assessed progression using RECIST v1.1 or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinical progression. |
| Secondary | Overall Survival (OS) | Up to 3.5 years | OS is defined as time from randomization until the date of death due to any cause. |
| Secondary | Central Nervous System Progression-free Survival (CNS PFS) | Up to 2.5 years | CNS PFS is defined as the time from randomization to BICR confirmed progression in the CNS or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinically progresses prior to BICR confirmed CNS modified RECIST v1.1 progression. |
| Secondary | Objective Response Rate (ORR) | Up to 2.5 years | ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by BICR per RECIST v1.1. |
| Secondary | Duration of Response (DoR) | Up to 2.5 years | DoR is defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, as assessed by BICR or death due to any cause. |
| Secondary | Progression-free Survival-2 (PFS-2) | Up to 3.5 years | PFS2 is defined as the time from randomization to the earliest of the progression event (following the initial investigator assessed progression), after first subsequent therapy, or death. |
| Secondary | Objective Response Rate (ORR) Using CNS Modified RECIST v1.1 | Up to 2.5 years | ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, using CNS modified RECIST v1.1. |
| Secondary | Duration of Response (DoR) Using CNS Modified RECIST v1.1 | Up to 2.5 years | DoR is defined as the time from the date of first documented response until date of documented progression or death due to any cause using CNS modified RECIST v1.1. |
| Secondary | Time to Deterioration in Pulmonary Symptoms | Up to 3.5 years | Time to deterioration (in pulmonary symptoms \[dyspnea, cough, and chest pain\]) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold. |
| Secondary | Time to Deterioration in Physical Functioning | Up to 3.5 years | Time to deterioration in physical functioning as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 8c will be evaluated. Time to deterioration (in physical functionating) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold. |
| Secondary | Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) | Up to 3.5 years | Time to deterioration in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172 will be reported. Time to deterioration (in GHS/QoL) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold. |
| Secondary | Pharmacokinetics (PK) of Dato-DXd | Up to 3.5 years | Concentration of Dato-DXd, total anti-TROP2 antibody and DXd in plasma. |
| Secondary | Immunogenicity of Dato-DXd | Up to 3.5 years | Presence of antidrug antibody (ADAs) for Dato-DXd (confirmatory results: positive or negative, titers). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06417814/registered