TriangleNCT02409342 · OUTCOME
Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 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)
What was measured
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
Analysis population: 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 \[WT\]).
Groups in this outcome
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
Atezolizumab
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
| Group | Source count |
|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 277 |
| Atezolizumab | 277 |
Reported measurements
TC2/3 or IC2/3-WT Population
| Group | Source count |
|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 162 |
| Atezolizumab | 166 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 5.5 | Not reported | 4.5 | 5.7 | Not reported |
| Atezolizumab | 7.3 | Not reported | 5.6 | 9.3 | Not reported |
TC1/2/3 or IC1/2/3-WT Population
| Group | Source count |
|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 277 |
| Atezolizumab | 277 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 5.6 | Not reported | 4.7 | 5.7 | Not reported |
| Atezolizumab | 5.8 | Not reported | 5.5 | 7.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.501
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.820
- group Description
- TC2/3 or IC2/3-WT Population
- group Ids
- OG000
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0004
- p Value Comment
- P-value is descriptive as it was not formally tested.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.641
- statistical Method
- Log Rank
- ci Lower Limit
- 0.595
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.863
- group Description
- TC1/2/3 or IC1/2/3-WT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0004
- p Value Comment
- P-value is descriptive as it was not formally tested.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.716
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.501
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.820
- group Description
- TC2/3 or IC2/3-WT Population
- group Ids
- OG000
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0004
- p Value Comment
- P-value is descriptive as it was not formally tested.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.641
- statistical Method
- Log Rank
- ci Lower Limit
- 0.595
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.863
- group Description
- TC1/2/3 or IC1/2/3-WT Population
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0004
- p Value Comment
- P-value is descriptive as it was not formally tested.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.716
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- 5.7
- value
- 5.5
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 9.3
- value
- 7.3
- denoms
- counts
- group Id
- OG000
- value
- 162
- group Id
- OG001
- value
- 166
- units
- Participants
- title
- TC2/3 or IC2/3-WT Population
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.7
- upper Limit
- 5.7
- value
- 5.6
- group Id
- OG001
- lower Limit
- 5.5
- upper Limit
- 7.3
- value
- 5.8
- denoms
- counts
- group Id
- OG000
- value
- 277
- group Id
- OG001
- value
- 277
- units
- Participants
- title
- TC1/2/3 or IC1/2/3-WT Population
- denoms
- counts
- group Id
- OG000
- value
- 277
- group Id
- OG001
- value
- 277
- units
- Participants
- description
- PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
- id
- OG000
- title
- Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
- description
- Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
- id
- OG001
- title
- Atezolizumab
- param Type
- NUMBER
- population Description
- 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 \[WT\]).
- reporting Status
- POSTED
- time Frame
- 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)
- title
- Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice