TriangleNCT02409342 · OUTCOME
Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline to 2 years or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
Analysis population: 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 \[WT\]).
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) | 98 |
| Atezolizumab | 107 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | 24.79 | Not reported | 13.11 | 36.47 | Not reported |
| Atezolizumab | 45.49 | Not reported | 32.11 | 58.88 | Not reported |
Source statistical analyses
- ci Lower Limit
- 2.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 38.47
- group Description
- 2-Years TC3 or IC3-WT Population
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Event Free Rate
- param Value
- 20.70
Complete source fields
- analyses
- ci Lower Limit
- 2.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 38.47
- group Description
- 2-Years TC3 or IC3-WT Population
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in Event Free Rate
- param Value
- 20.70
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.11
- upper Limit
- 36.47
- value
- 24.79
- group Id
- OG001
- lower Limit
- 32.11
- upper Limit
- 58.88
- value
- 45.49
- denoms
- counts
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 107
- units
- Participants
- 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 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 \[WT\]).
- reporting Status
- POSTED
- time Frame
- Baseline to 2 years or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
- title
- Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice