TriangleNCT04334759 · OUTCOME
Objective Tumour Response Rate (OTRR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Disease was evaluated at baseline, then 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). The treatment duration ranged from 0 to 36 months.
What was measured
Objective tumour response rate (OTRR) is defined as the proportion of participants with a documented complete response, partial response (CR + PR) based on iRECIST criteria.
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 | 0.566 | Not reported | 0.470 | 0.660 | Not reported |
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 0.350 | Not reported | 0.231 | 0.484 | Not reported |
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 0.529 | Not reported | 0.278 | 0.770 | Not reported |
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 0.435 | Not reported | 0.232 | 0.655 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.470
- upper Limit
- 0.660
- value
- 0.566
- group Id
- OG001
- lower Limit
- 0.231
- upper Limit
- 0.484
- value
- 0.350
- group Id
- OG002
- lower Limit
- 0.278
- upper Limit
- 0.770
- value
- 0.529
- group Id
- OG003
- lower Limit
- 0.232
- upper Limit
- 0.655
- value
- 0.435
- 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
- Objective tumour response rate (OTRR) is defined as the proportion of participants with a documented complete response, partial response (CR + PR) based on iRECIST criteria.
- 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
- NUMBER
- 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, then 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). The treatment duration ranged from 0 to 36 months.
- title
- Objective Tumour Response Rate (OTRR)
- type
- SECONDARY
- unit Of Measure
- proportion of participants
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Preserved source evidence · Not medical advice