Trial · NCT04256421
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator-Assessed Progression Free Survival (PFS) in the Primary Analysis Set (PAS) | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months) | Primary analysis set (PAS): All randomized participants without presence or history of brain metastases at baseline. | months | MEDIAN |
| PRIMARY | Overall Survival (OS) in the PAS | From randomization to death from any cause (up to approximately 24 months) | PAS: All randomized participants without presence or history of brain metastases at baseline. | months | MEDIAN |
| SECONDARY | PFS in the FAS | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 24 months) | FAS: All randomized participants, whether or not the participant received the assigned treatment. | months | MEDIAN |
| SECONDARY | OS in the FAS | From randomization to death from any cause (up to approximately 24 months) | FAS: All randomized participants, whether or not the participant received the assigned treatment. | months | MEDIAN |
| SECONDARY | Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS | From randomization up to approximately 24 months | PAS: All randomized participants without presence or history of brain metastases at baseline. | percentage of participants | NUMBER |
| SECONDARY | Investigator-Assessed Confirmed ORR in the FAS | From randomization up to approximately 24 months | FAS: All randomized participants, whether or not the participant received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Investigator-Assessed Duration of Response (DOR) in the PAS | From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) | PAS: All randomized participants without presence or history of brain metastases at baseline. DOR was analyzed in confirmed responders by investigator. | months | MEDIAN |
| SECONDARY | Investigator-Assessed DOR in the FAS | From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) | FAS: All randomized participants, whether or not the participant received the assigned treatment. DOR was analyzed in confirmed responders by investigator. | months | MEDIAN |
| SECONDARY | Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS | Month 6, Month 12 | PAS: All randomized participants without presence or history of brain metastases at baseline. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | percentage of participants | NUMBER |
| SECONDARY | Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS | Month 6, Month 12 | FAS: All randomized participants, whether or not the participant received the assigned treatment. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival Rates at 12 Months and 24 Months in the PAS | Month 12, Month 24 | PAS: All randomized participants without presence or history of brain metastases at baseline. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival Rates at 12 Months and 24 Months in the FAS | Month 12, Month 24 | FAS: All randomized participants, whether or not the participant received the assigned treatment. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | percentage of participants | NUMBER |
| SECONDARY | Time to Confirmed Deterioration (TTCD) of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Physical Functioning in the PAS | From randomization until the first confirmed clinically meaningful deterioration up to approximately 24 months | PAS: All randomized participants without presence or history of brain metastases at baseline. | months | MEDIAN |
| SECONDARY | TTCD of EORTC QLQ-C30 Physical Functioning in the FAS | From randomization until the first confirmed clinically meaningful deterioration up to approximately 24 months | FAS: All randomized participants, whether or not the participant received the assigned treatment. | months | MEDIAN |
| SECONDARY | TTCD of EORTC QLQ-C30 Global Health Status (GHS)/Quality of Life (QoL) in the PAS | From randomization until the first confirmed clinically meaningful deterioration up to approximately 24 months | PAS: All randomized participants without presence or history of brain metastases at baseline. | months | MEDIAN |
| SECONDARY | TTCD of EORTC QLQ-C30 GHS/QoL in the FAS | From randomization until the first confirmed clinically meaningful deterioration up to 24 months | FAS: All randomized participants, whether or not the participant received the assigned treatment. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events | Up to 65 months | |||
| SECONDARY | Minimum Serum Concentration (Cmin) of Tiragolumab | At the end of each cycle (each cycle is 21 days) of Cycles 1, 2, 3, 7, 11 and 15 (approximately 11 months) | PK-evaluable set: All participants who received at least one dose of study treatment and who had at least one post-baseline PK sample available. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | microgram/milliliter (mcg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Cmin of Atezolizumab | At the end of each cycle (each cycle is 21 days) of Cycles 1, 2, 3, 7, 11 and 15 (approximately 11 months) | PK-evaluable set: All participants who received at least one dose of study treatment and who had at least one post-baseline PK sample available. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Serum Concentration (Cmax) of Tiragolumab | Predose and 30 minutes post end of infusion (EOI) on Day 1 of Cycle 1 (each cycle is 21 days) | PK-evaluable set: All participants who received at least one dose of study treatment and who had at least one post-baseline PK sample available. Overall number of participants analyzed is the number of participants with data available for analyses | mcg/mL | GEOMETRIC_MEAN |
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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GET https://conductscience.org/api/trials/v1/NCT04256421/outcomes