TriangleNCT03041311 · OUTCOME
Duration of Objective Response (Complete Response or Partial Response)
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, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.
What was measured
Duration of Response (DOR) is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Patients who do not experience PD or death will be censored at the last tumor assessment date. Only those patients with confirmed responses will be included in this analysis.
Analysis population: Response Evaluable 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 | 28 |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 33 |
Reported measurements
25%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 4.4 | Not reported | 2.9 | 4.7 | Not reported |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 3.0 | Not reported | 2.7 | 4.1 | Not reported |
Median
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 5.6 | Not reported | 4.4 | 7.0 | Not reported |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 4.3 | Not reported | 3.4 | 4.7 | Not reported |
75%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trilaciclib+Etoposide/Carboplatin/Atezolizumab | 8.3 | Not reported | 5.8 | 13.2 | Not reported |
| Placebo+Etoposide/Carboplatin/Atezolizumab | 5.0 | Not reported | 4.6 | 10.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.9
- upper Limit
- 4.7
- value
- 4.4
- group Id
- OG001
- lower Limit
- 2.7
- upper Limit
- 4.1
- value
- 3.0
- title
- 25%
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.4
- upper Limit
- 7.0
- value
- 5.6
- group Id
- OG001
- lower Limit
- 3.4
- upper Limit
- 4.7
- value
- 4.3
- title
- Median
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.8
- upper Limit
- 13.2
- value
- 8.3
- group Id
- OG001
- lower Limit
- 4.6
- upper Limit
- 10.5
- value
- 5.0
- title
- 75%
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 33
- units
- Participants
- description
- Duration of Response (DOR) is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Patients who do not experience PD or death will be censored at the last tumor assessment date. Only those patients with confirmed responses will be included in this analysis.
- 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
- Response Evaluable Analysis Set
- reporting Status
- POSTED
- time Frame
- From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.
- title
- Duration of Objective Response (Complete Response or Partial Response)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice