TriangleNCT04334759 · OUTCOME
Median 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
- Minimum follow-up is 24 months after randomisation. Median follow-up for survival is of 33 months with range (3 months - 47 months).
What was measured
OS based on the Kaplan-Meier method is defined as the duration from randomisation to the date of death due to any cause, or is censored at date last known alive.
Analysis population: The analysis population is comprised of intention-to-treat patients. One patient in the experimental arm of the Chemo Cohort was excluded due to a randomization error, with no treatment or follow-up data available.
Groups in this outcome
Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
Control Arm for Chemo Cohort: Chemotherapy, Then Observation
Standard Chemotherapy for 4 to 6 cycles, followed by Observation Standard Chemotherapy: Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks) for 4 to 6 cycles, followed by Observation
Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
Control Arm for IO Cohort: Ipilimumab and Nivolumab
Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years. Ipilimumab and Nivolumab: Ipilimumab 1 mg/kg every 6 weeks and Nivolumab 360 mg every 3 weeks or 3 mg/kg every 2 weeks for up to 2 years
| Group | Source count |
|---|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 113 |
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 60 |
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 17 |
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 21 | Not reported | 18 | 27 | Not reported |
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 18 | Not reported | 14 | 30 | Not reported |
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 21 | Not reported | 9.2 | NA | The upper level of 95% Confidence interval is not reached. |
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | NA | Not reported | NA | NA | Median and 95% confidence intervals are not reached due to the small number of events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18
- upper Limit
- 27
- value
- 21
- group Id
- OG001
- lower Limit
- 14
- upper Limit
- 30
- value
- 18
- comment
- The upper level of 95% Confidence interval is not reached.
- group Id
- OG002
- lower Limit
- 9.2
- upper Limit
- NA
- value
- 21
- comment
- Median and 95% confidence intervals are not reached due to the small number of events.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 60
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 23
- units
- Participants
- description
- OS based on the Kaplan-Meier method is defined as the duration from randomisation to the date of death due to any cause, or is censored at date last known alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
- id
- OG000
- title
- Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Standard Chemotherapy for 4 to 6 cycles, followed by Observation Standard Chemotherapy: Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks) for 4 to 6 cycles, followed by Observation
- id
- OG001
- title
- Control Arm for Chemo Cohort: Chemotherapy, Then Observation
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab Durvalumab: Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
- id
- OG002
- title
- Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years. Ipilimumab and Nivolumab: Ipilimumab 1 mg/kg every 6 weeks and Nivolumab 360 mg every 3 weeks or 3 mg/kg every 2 weeks for up to 2 years
- id
- OG003
- title
- Control Arm for IO Cohort: Ipilimumab and Nivolumab
- param Type
- MEDIAN
- population Description
- The analysis population is comprised of intention-to-treat patients. One patient in the experimental arm of the Chemo Cohort was excluded due to a randomization error, with no treatment or follow-up data available.
- reporting Status
- POSTED
- time Frame
- Minimum follow-up is 24 months after randomisation. Median follow-up for survival is of 33 months with range (3 months - 47 months).
- title
- Median Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice