TriangleNCT04334759 · OUTCOME
Median Progression-Free Survival (PFS)
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
- Disease was evaluated at baseline, at weeks 6, 12, 18, 26, 34, 42, 50 and then every 12 weeks until disease progression (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
PFS based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) defined per modified RECIST 1.1 for PM and iRECIST, or death, or is censored at time of last disease assessment.
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 | 8.0 | Not reported | 7.8 | 9.8 | Not reported |
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 7 | Not reported | 5.9 | 8 | Not reported |
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 7.8 | Not reported | 6.5 | 11 | Not reported |
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 7.7 | Not reported | 6.1 | NA | The upper level of the 95% Confidence Interval is not reached. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.8
- upper Limit
- 9.8
- value
- 8.0
- group Id
- OG001
- lower Limit
- 5.9
- upper Limit
- 8
- value
- 7
- group Id
- OG002
- lower Limit
- 6.5
- upper Limit
- 11
- value
- 7.8
- comment
- The upper level of the 95% Confidence Interval is not reached.
- group Id
- OG003
- lower Limit
- 6.1
- upper Limit
- NA
- value
- 7.7
- 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
- PFS based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) defined per modified RECIST 1.1 for PM and iRECIST, or death, or is censored at time of last disease assessment.
- 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
- Disease was evaluated at baseline, at weeks 6, 12, 18, 26, 34, 42, 50 and then every 12 weeks until disease progression (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 Progression-Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice