Trial · NCT05687266
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) by blinded independent central review (BICR) in the non-squamous TROP2 biomarker positive population | Approximately 3 years | PFS is defined as time from randomisation until progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by BICR, or death due to any cause. |
| Primary | Overall Survival (OS) in the non-squamous TROP2 biomarker positive population | Approximately 5 years | OS is defined as the time from randomisation until the date of death due to any cause. |
| Primary | PFS by BICR in the non-squamous population | Approximately 3 years | PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. |
| Primary | OS in the non-squamous population | Approximately 5 years | OS is defined as the time from randomisation until the date of death due to any cause. |
| Secondary | PFS by BICR in ITT and TROP2 biomarker-defined populations | Approximately 3 years | PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. |
| Secondary | OS in ITT and TROP2 biomarker-defined populations | Approximately 5 years | OS is defined as the time from randomisation until the date of death due to any cause. |
| Secondary | Objective Response Rate (ORR) in ITT, non-squamous and TROP2 biomarker-defined populations | Approximately 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 BICR per RECIST 1.1. |
| Secondary | Duration of Response (DoR) in ITT, non-squamous and TROP2 biomarker-defined populations | Approximately 5 years | DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR and investigator clinical assessment or death due to any cause. |
| Secondary | PFS by investigator in ITT, non-squamous and TROP2 biomarker-defined populations | Approximately 3 years | PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by investigator clinical assessment, or death due to any cause. |
| Secondary | Pharmacokinetics of Dato-DXd when combined with durvalumab and carboplatin. | Approximately 5 years | Concentration of Dato-DXd, total anti-TROP2 antibody, and DXd (payload deruxtecan) in plasma and pharmacokinetic (PK) parameters (such as peak and trough concentrations, as data allow; sparse sampling). |
| Secondary | Anti-Drug Antibody (ADA) for Dato-DXd | Approximately 5 years | The immunogenicity of Dato-DXd when combined with durvalumab and carboplatin. |
| Secondary | Time to Second Progression or Death (PFS2) in ITT, non-squamous and TROP2 biomarker-defined populations | Approximately 5 years | PFS2 is defined as the time from randomisation to the earliest of the progression events (following the initial progression), subsequent to first subsequent therapy, or death. |
| Secondary | Clinical Outcome Assessments in ITT, non-squamous and TROP2 biomarker-defined populations | Approximately 5 years | Clinical Outcome Assessments, such as TTD in pulmonary symptoms (dyspnoea, cough and chest pain) as measured by the NSCLC-SAQ, and TTD in physical functioning as measured by PROMIS Physical Function short form 8c |
| Other | Safety of Dato-DXd in combination with durvalumab and carboplatin | Approximately 5 years | Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE Version 5.0). |
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.
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