Trial · NCT03043872
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP | From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months). | The global FAS included all patients randomized prior to the end of global recruitment. Interim analysis for OS in the global cohort was performed for comparison of the D + EP vs EP groups only. | months | MEDIAN |
| PRIMARY | OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP | From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | The global FAS included all patients randomized prior to the end of global recruitment. | months | MEDIAN |
| PRIMARY | OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP | From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months). | The China FAS included all randomized patients in the China cohort. China cohort first analysis for OS was performed for comparison of the D + EP vs EP groups only. | months | MEDIAN |
| PRIMARY | OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP | From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months). | The China FAS included all randomized patients in the China cohort. | months | MEDIAN |
| SECONDARY | OS in the Global Cohort; D + T + EP Compared With D + EP | From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | The global FAS included all patients randomized prior to the end of global recruitment. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | The global FAS included all patients randomized prior to the end of global recruitment. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | The global FAS included all patients randomized prior to the end of global recruitment. The denominator was a subset of the FAS population who had measurable disease at baseline. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Alive and Progression Free at 6 Months (APF6) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 6 months post-randomization. | The global FAS included all patients randomized prior to the end of global recruitment. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Alive and Progression Free at 12 Months (APF12) in the Global Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until 12 months post-randomization. | The global FAS included all patients randomized prior to the end of global recruitment. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Alive at 18 Months (OS18) in the Global Cohort | At 18 months post-randomization. Assessed at the global cohort final analysis DCO (27 January 2020). | The global FAS included all patients randomized prior to the end of global recruitment. | percentage of patients | NUMBER |
| SECONDARY | Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations in the Global Cohort | Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020). | The global PK analysis set included all patients randomized prior to the end of global recruitment who received at least 1 dose of investigational product (IP), per the protocol for whom any post-dose PK data were available. PK for durvalumab was performed for the D + T + EP and D + EP groups only. | micrograms/milliliter (μg/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK of Tremelimumab; Peak and Trough Serum Concentrations in the Global Cohort | Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020). | The global PK analysis set included all patients randomized prior to the end of global recruitment who received at least 1 dose of IP, per the protocol for whom any post-dose PK data were available. PK for tremelimumab was performed for the D + T + EP group only. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab in the Global Cohort | Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, durvalumab). Assessed at the global cohort final analysis DCO (27 January 2020). | The global ADA evaluable patients included those in the global safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for durvalumab was performed for the D + T + EP and D + EP groups only. The denominator was durvalumab ADA evaluable patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With ADA Response to Tremelimumab in the Global Cohort | Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the global cohort final analysis DCO (27 January 2020). | The global ADA evaluable patients included those in the global safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for tremelimumab was performed for the D + T + EP group only. The denominator was tremelimumab ADA evaluable patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Deterioration of Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) in the Global Cohort | At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | The global FAS included all patients randomized prior to the end of global recruitment. For QLQ-C30 function scales and global health status/HRQoL, only patients with baseline scores ≥10 (and with data available) were included in the analysis. For QLQ-C30 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis. | months | MEDIAN |
| SECONDARY | Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13) in the Global Cohort | At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until global cohort final analysis DCO (maximum of approximately 33 months). | The global FAS included all patients randomized prior to the end of global recruitment. For QLQ-L13 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis. | months | MEDIAN |
| SECONDARY | Change From Baseline in Primary PRO Symptoms as Assessed by EORTC QLQ in the Global Cohort; D + T + EP Compared With EP | At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months. | The global FAS included all patients randomized prior to the end of global recruitment. For each symptom scale, only patients with data available were included in the analysis. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Primary Symptoms, Assessed Using EORTC QLQ-C30 and EORTC QLQ-LC13 in the Global Cohort; D + EP Compared With EP | At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed up to 12 months. | The global FAS included all patients randomized prior to the end of global recruitment. For each symptom scale, only patients with data available were included in the analysis. | scores on a scale | MEAN |
| SECONDARY | OS in the China Cohort; D + T + EP Compared With D + EP | From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months). | The China FAS included all randomized patients in the China cohort. | months | MEDIAN |
| SECONDARY | PFS in the China Cohort | Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until China cohort second analysis DCO (maximum of approximately 29 months). | The China FAS included all randomized patients in the China cohort. | months | MEDIAN |
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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