Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

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List	Outcome	Time frame	Description
Primary	Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC)	From date of randomization until time of final analysis, an average of approximately 4 years	Number of participants with Overall Survival (OS)
Primary	Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup	From date of randomization until time of final analysis, an average of approximately 4 years	Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)
Secondary	Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC)	From date of randomization until time of final analysis, an average of approximately 4 years	Number of participants with Overall Survival (OS)
Secondary	Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup	12, 18 and 24 months after randomization	Percentage of patients alive
Secondary	Progression Free Survival (PFS) in the PD-L1 TC/IC High Subgroup	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years	Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Secondary	Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years	Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: \>= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)
Secondary	Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years	Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression
Secondary	Overall Survival (OS) Status in the All-comers (Full Analysis Set)	From date of randomization until time of final analysis, an average of approximately 4 years	Number of participants with Overall Survival (OS)
Secondary	Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set)	From date of randomization until time of final analysis, an average of approximately 4 years	Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)
Secondary	Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set)	12, 18 and 24 months after randomization	Percentage of patients alive
Secondary	Progression Free Survival (PFS) in the All-comers (Full Analysis Set)	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years	Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Secondary	Objective Response Rate (ORR) in the All-comers (Full Analysis Set)	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years	Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: \>= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)
Secondary	Duration of Response (DoR) in the All-comers (Full Analysis Set)	Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years	Time from the date of first documented response until the first date of documented progression or death in the absence of disease 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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