TriangleNCT05091567 · OUTCOME
Randomized Phase: Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 26 months
What was measured
OS was defined as the time from randomization to the date of death from any cause.
Analysis population: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
Groups in this outcome
Atezolizumab
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
Atezolizumab+ Lurbinectedin
Participants received atezolizumab, 1200 mg, Q3W as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
| Group | Source count |
|---|---|
| Atezolizumab | 241 |
| Atezolizumab+ Lurbinectedin | 242 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab | 10.64 | 9.49 | 9.49 | 12.16 | Not reported |
| Atezolizumab+ Lurbinectedin | 13.24 | 11.89 | 11.89 | 16.36 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.95
- group Description
- Stratified Analysis: The stratification factors were ECOG PS at randomization (0 vs. 1); LDH at randomization (\<=ULN vs \>ULN) via local laboratory test; Presence of liver metastases at enrollment (yes vs. no); Prior receipt of PCI (yes vs. no).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.0174
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.95
- group Description
- Stratified Analysis: The stratification factors were ECOG PS at randomization (0 vs. 1); LDH at randomization (\<=ULN vs \>ULN) via local laboratory test; Presence of liver metastases at enrollment (yes vs. no); Prior receipt of PCI (yes vs. no).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.0174
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.49
- spread
- 9.49
- upper Limit
- 12.16
- value
- 10.64
- group Id
- OG001
- lower Limit
- 11.89
- spread
- 11.89
- upper Limit
- 16.36
- value
- 13.24
- denoms
- counts
- group Id
- OG000
- value
- 241
- group Id
- OG001
- value
- 242
- units
- Participants
- description
- OS was defined as the time from randomization to the date of death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
- id
- OG000
- title
- Atezolizumab
- description
- Participants received atezolizumab, 1200 mg, Q3W as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
- id
- OG001
- title
- Atezolizumab+ Lurbinectedin
- param Type
- MEDIAN
- population Description
- FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
- reporting Status
- POSTED
- time Frame
- Up to 26 months
- title
- Randomized Phase: Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice