Trial · NCT05555732
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants | From randomization until disease progression or death (whichever occurs first), up to approximately 43 months | Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. |
| Primary | Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants who are TROP2 NMR positive | From randomization until disease progression or death (whichever occurs first), up to approximately 43 months | Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. |
| Primary | Overall Survival in All Randomized Participants | From randomization until disease progression or death (whichever occurs first), up to approximately 76 months | Overall Survival (OS) is defined as the time from randomization to death due to any cause. |
| Primary | Overall Survival in All Randomized Participants who are TROP2 NMR positive | From randomization until disease progression or death (whichever occurs first), up to approximately 76 months | Overall Survival (OS) is defined as the time from randomization to death due to any cause. |
| Secondary | Objective Response Rate by Blinded Independent Central Review in All Randomized Participants | From randomization until disease progression or death (whichever occurs first), up to approximately 43 months | Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1. |
| Secondary | Objective Response Rate by Blinded Independent Central Review in All Randomized Participants who are TROP2 NMR positive | From randomization until disease progression or death (whichever occurs first), up to approximately 43 months | Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1. |
| Secondary | Progression-free Survival by Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive | From randomization until disease progression or death (whichever occurs first), up to approximately 43 months | Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1. |
| Secondary | Objective Response Rate by Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive | From randomization until disease progression or death (whichever occurs first), up to approximately 43 months | Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by the Investigator per RECIST Version 1.1. |
| Secondary | Duration of Response by BICR and Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive | From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 43 months | Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first radiographic disease progression or death due to any cause, whichever occurs first, assessed by BICR and by the Investigator per RECIST Version 1.1. |
| Secondary | Time to Response by BICR and Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive | From randomization to date of first objective response (CR or PR), up to approximately 43 months | Time to Response (TTR) is defined as the time from randomization to the date of the first documentation of objective response (confirmed CR or confirmed PR) in responding participants, assessed by BICR and by the Investigator per RECIST Version 1.1. |
| Secondary | Disease Control Rate by BICR and Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive | From randomization until disease progression or death (whichever occurs first), up to approximately 43 months | Disease Control Rate (DCR) is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by BICR and by the Investigator per RECIST Version 1.1. |
| Secondary | Progression-free Survival 2 in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive | From randomization until disease progression or death (whichever occurs first), up to approximately 76 months | Progression-free Survival 2 (PFS2) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by local standard clinical practice |
| Secondary | Time to Deterioration | From randomization until disease progression or death (whichever occurs first), up to approximately 76 months | Time to Deterioration (TTD) is defined as the time from randomization to first onset of a ≥10-point increase in cough, chest pain, or dyspnea, confirmed by a second adjacent ≥10-point increase from randomization in the same symptom, or confirmed by death within 21 days of a ≥10-point increase from randomization, assessed the European Organization for Research and Treatment of Cancer Lung cancer module (EORTC-QLQ-LC13). |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Up to 76 months | A TEAE is defined as an AE with a start or worsening date on or after the start date of study treatment until 37 days after the end date of study treatment. |
| Secondary | Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA | Baseline and up to 76 months | The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed. |
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
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