Trial · NCT02409342
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in the TC3 or IC3-WT Populations | From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months) | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) in the TC3 or IC3-WT Populations | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Months | NUMBER |
| SECONDARY | Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months) | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Months | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations | Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 10 Sep 2018 (up to approximately 38 months) | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 4 Feb 2020 (up to approximately 54.5 months) | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) in the TC3 or IC3-WT Populations | From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Months | NUMBER |
| SECONDARY | Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months) | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Months | NUMBER |
| SECONDARY | Percentage of Participants Who Are Alive at 1 Year in the TC3 or IC3-WT Populations | Baseline to 1 year or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations | Baseline to 2 years or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Are Alive at 1 Year in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | Baseline to 1 year or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months) | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Are Alive at 2 Years in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | Baseline to 2 years or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months) | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]). | Percentage of participants | NUMBER |
| SECONDARY | Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations | Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for the TC3 or IC3-WT Populations. | Months | MEDIAN |
| SECONDARY | Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations | Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for the TC3 or IC3-WT Populations. | Score on a scale | MEAN |
| SECONDARY | TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations | Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for the TC3 or IC3-WT Populations. | Months | MEDIAN |
| SECONDARY | OS in Participants With PD-L1 Expression | From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for participants with PD-L1 Expression of PD-L1 status by SP263 \>=50%, SP263 \>=25%, SP263 \>=1% in the Intent-to-Treat Wild Type Population. | Months | MEDIAN |
| SECONDARY | Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1 | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for participants with PD-L1 Expression of PD-L1 status by SP263 \>=50%, SP263 \>=25%, SP263 \>=1% in the Intent-to-Treat Wild Type Population. | Months | MEDIAN |
| SECONDARY | OS in Participants With Blood Tumor Mutational Burden (bTMB) | From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for the bTMB subpopulations in the Intent-to-Treat Wild Type population. | Months | MEDIAN |
| SECONDARY | Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1 | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) | Analysis was performed for participants with bTMB \>=10 Intent-to-treat Wild Type Population. | Months | MEDIAN |
| SECONDARY | Minimum Observed Serum Concentration (Cmin) of Atezolizumab | Prior to infusion (0 hour) on Day 1 of Cycles 2, 3, 4, 8, 16, and every eighth cycle thereafter, and at treatment discontinuation until data cut-off on 10 September 2018 (up to approximately 38 months) (cycle duration = 21 days) | PK analyses was based on PK observations from all randomized participants who received atezolizumab and provided at least one PK sample that was evaluable. | micrograms per milliliter (μg/ mL) | 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.
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