TriangleNCT03041311 · OUTCOME
Overall Survival (OS)
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 date of randomization to date of death due to any cause, assessed up to a maximum of 38.1 months.
What was measured
Overall survival was calculated as the time (months) from date of randomization to the date of death due to any cause. Patients who did not die during the study were censored at the date last known to be alive. Patients lacking data beyond the date of randomization had their survival time censored at date of randomization. Overall survival was not censored if a patient received other anti-tumor treatments after the study drugs. Overall survival was calculated using the Kaplan-Meier method.
Analysis population: Intent-to-treat (ITT Analysis Set)
Groups in this outcome
Trilaciclib+Etoposide/Carboplatin/Atezolizumab
Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.
Placebo+Etoposide/Carboplatin/Atezolizumab
Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.
| Group | Source count |
|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 54 |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 53 |
Reported measurements
25%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 7.2 | Not reported | 4.9 | 10.2 | Not reported |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 6.7 | Not reported | 3.6 | 8.1 | Not reported |
Median
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 12.0 | Not reported | 9.6 | 16.2 | Not reported |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 12.8 | Not reported | 7.9 | 15.5 | Not reported |
75%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 20.6 | Not reported | 14.5 | 23.2 | Not reported |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 22.4 | Not reported | 15.5 | 30.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.52
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.218
- estimate Comment
- The HR and its 95% CI were calculated using the Cox proportional hazard regression model with treatment and stratification factors of ECOG performance status (0 to 1 versus 2) and presence of brain metastases (Yes versus No).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- For time-to-event variable, the Kaplan-Meier method was used to estimate its within group median value, 25% and 75% percentile values.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9942
- p Value Comment
- The 2-sided p-value was obtained from the stratified log-rank test to account for the stratification factors.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.99
- statistical Comment
- stratified log-rank test
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.52
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.218
- estimate Comment
- The HR and its 95% CI were calculated using the Cox proportional hazard regression model with treatment and stratification factors of ECOG performance status (0 to 1 versus 2) and presence of brain metastases (Yes versus No).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- For time-to-event variable, the Kaplan-Meier method was used to estimate its within group median value, 25% and 75% percentile values.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9942
- p Value Comment
- The 2-sided p-value was obtained from the stratified log-rank test to account for the stratification factors.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.99
- statistical Comment
- stratified log-rank test
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.9
- upper Limit
- 10.2
- value
- 7.2
- group Id
- OG001
- lower Limit
- 3.6
- upper Limit
- 8.1
- value
- 6.7
- title
- 25%
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.6
- upper Limit
- 16.2
- value
- 12.0
- group Id
- OG001
- lower Limit
- 7.9
- upper Limit
- 15.5
- value
- 12.8
- title
- Median
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.5
- upper Limit
- 23.2
- value
- 20.6
- group Id
- OG001
- lower Limit
- 15.5
- upper Limit
- 30.0
- value
- 22.4
- title
- 75%
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 53
- units
- Participants
- description
- Overall survival was calculated as the time (months) from date of randomization to the date of death due to any cause. Patients who did not die during the study were censored at the date last known to be alive. Patients lacking data beyond the date of randomization had their survival time censored at date of randomization. Overall survival was not censored if a patient received other anti-tumor treatments after the study drugs. Overall survival was calculated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.
- id
- OG000
- title
- Trilaciclib+Etoposide/Carboplatin/Atezolizumab
- description
- Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.
- id
- OG001
- title
- Placebo+Etoposide/Carboplatin/Atezolizumab
- param Type
- NUMBER
- population Description
- Intent-to-treat (ITT Analysis Set)
- reporting Status
- POSTED
- time Frame
- From date of randomization to date of death due to any cause, assessed up to a maximum of 38.1 months.
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice