Trial · NCT03371017
Outcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in PD-L1-positive Population | Time from randomization to death (Up to 68 months) | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | months | MEDIAN |
| PRIMARY | OS in Modified Intent-to-treat (mITT) Population | Time from randomization to death (Up to 68 months) | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | 12-month Survival Rate in PD-L1-positive Population | 12 months | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | percentage of participants | NUMBER |
| SECONDARY | 12-month Survival Rate in mITT Population | 12 months | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | percentage of participants | NUMBER |
| SECONDARY | 18-month Survival Rate in PD-L1-positive Population | 18 months | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | percentage of participants | NUMBER |
| SECONDARY | 18-month Survival Rate in mITT Population | 18 months | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) in PD-L1-positive Population | Time from randomization to the first occurrence of PD or death (Up to 68 months) | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | PFS in mITT Population | Time from randomization to the first occurrence of PD or death (Up to 68 months) | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) in Response-evaluable Population, Subset of PD-L1-positive Population | Baseline up to end of study (Up to 68 months) | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable Population included participants randomized in the study with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | ORR in Response-evaluable Population, Subset of mITT Population | Baseline up to end of study (Up to 68 months) | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1 (SP142)-positive and PD-L1 (SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable Population included participants randomized in the study with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response (DoR) in DoR-evaluable Population Subset of PD-L1-positive Population | Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months) | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. DOR-evaluable population included participants randomized in the study with measurable disease at baseline and an OR. | months | MEDIAN |
| SECONDARY | DoR in DoR-evaluable Population Subset of mITT Population | Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months) | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. DOR-evaluable population included participants randomized in the study with measurable disease at baseline and an OR. | months | MEDIAN |
| SECONDARY | Clinical Benefit Rate (CBR) in Response-evaluable Population Subset of PD-L1-positive Population | Up to 68 months | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating immune cells IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable population included participants randomized in the study with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | CBR in Response-evaluable Population Subset of mITT Population | Up to 68 months | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable population included participants randomized in the study with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | Confirmed Objective Response Rate (C-ORR) in Response-evaluable Population Subset of PD-L1-positive Population | Up to 68 months | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable population included participants randomized in the study with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | C-ORR in Response-evaluable Population Subset of mITT Population | Up to 68 months | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. Response-evaluable population included participants randomized in the study with measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | DoR for Confirmed Responders (C-DoR) in C-DoR-evaluable Population Subset of PD-L1-positive Population | Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months) | PD-L1 population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. C-DOR-evaluable population included participants randomized in the study with measurable disease at baseline and a confirmed OR. | months | MEDIAN |
| SECONDARY | C-DoR in C-DoR-evaluable Population Subset of mITT Population | Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months) | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. C-DOR-evaluable population included participants randomized in the study with measurable disease at baseline and a confirmed OR. | months | MEDIAN |
| SECONDARY | Time to Confirmed Deterioration (TTD) in Global Health Status/Quality of Life (GHS/QoL) According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) in PD-L1-positive Population | Up to 68 months | PD-L1 positive population included all participants randomized in the study whose PD-L1 status was tumor-infiltrating IC of 1% or greater (IC1/2/3) at the time of randomization, grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | TTD in GHS/QoL According to EORTC QLQ-C30 in mITT Population | Up to 68 months | mITT population included all participants randomized under the protocol versions prior to version 4.0 (referred to as all-comers, i.e., PD-L1(SP142)-positive and PD-L1(SP142)-negative participants), grouped according to their assigned treatment arm, whether or not the assigned study treatment was received. | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03371017/outcomes