Trial · NCT06350097
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Progression Free Survival (PFS) by BICR in all randomised participants. | It is anticipated that it will be performed approximately 3 years after the first participant is randomised. | PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). |
| Secondary | To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Overall Survival (OS) in all randomised participants. | It is anticipated that it will be performed approximately 7 years after the first participant has been randomised. | OS defined as the time from randomisation until the date of death due to any cause. |
| Secondary | To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS on Central nervous system (CNS) metastases in participants with CNS metastases at baseline | It is anticipated that it will be performed approximately 3 years after the first participant is randomised. | Central nervous system progression-free survival (CNS PFS) is defined as the time from randomisation until the date of objective CNS progression assessed by CNS BICR or death (by any cause in absence of CNS progression). |
| Secondary | To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by investigator in all randomised participants. | It is anticipated that it will be performed approximately 3 years after the first participant is randomised. | PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by investigator, or death due to any cause (in the absence of progression). |
| Secondary | To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Overall Response Rate (ORR) in all randomised participants with measurable disease at baseline. | It is anticipated that it will be performed approximately 3 years after the first participant is randomised. | ORR is defined as the proportion of participants who have a confirmed Complete Response (CR) or confirmed Partial Response (PR), as determined by BICR (and investigator) per RECIST 1.1. |
| Secondary | To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Duration of Response (DoR) in all randomised participants with measurable disease at baseline. | It is anticipated that it will be performed approximately 3 years after the first participant is randomised. | 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) assessment or death due to any cause. The measure of interest is the median of DoR. |
| Secondary | To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib on the prevention of CNS metastases | It is anticipated that it will be performed approximately 3 years after the first participant is randomised. | Neuro-radiologist assessments according to CNS RECIST 1.1 to determine the presence/absence of CNS lesions at progression in participants without CNS metastases at baseline. |
| Secondary | To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS2 in all randomised participants | It is anticipated that it will be analyzed by time of PFS primary which is about 3 years after the first participant has been randomised. | PFS2 will be defined as the time from randomisation to the earliest of the progression event (following the initial progression) subsequent to first subsequent anti-cancer therapy, or death. |
| Secondary | To assess the Pharmacokinetics (PK) of osimertinib and Datopotamab Deruxtecan | It is anticipated that it will be performed approximately 3 years after the first participant has been randomised. | Concentration of osimertinib and its metabolite AZ5104, Datopotamab Deruxtecan, and DXd in plasma. |
| Secondary | To investigate the immunogenicity of Datopotamab Deruxtecan | It is anticipated that it will be performed approximately 3 years after the first participant has been randomised, together with PFS primary. | Presence of ADAs for Datopotamab Deruxtecan (confirmatory results: positive or negative, titres, and neutralizing antibodies). |
| Secondary | To compare the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results from baseline tumour samples | It is anticipated that it will be performed approximately 3 years after the first participant is randomised. | Concordance of EGFR mutation status between the local EGFR mutation test and the central cobas® EGFR Mutation Test v2 results from tumour samples with evaluable results. |
| Secondary | To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan vs. osimertinib monotherapy based on the cobas® EGFR Mutation Test v2 plasma screening test result for Ex19del or L858R EGFR mutations | It is anticipated that it will be performed approximately 3 years after the first participant has been randomised, together with PFS primary. | PFS by Investigator by plasma EGFR mutation status PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by investigator, or death due to any cause (in the absence of progression). |
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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