TriangleNCT02477826 · OUTCOME
Objective Response Rate (ORR) Per BICR
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
What was measured
Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Analysis population: All randomized participants
Groups in this outcome
Part 1-Arm B: Nivo + Ipi
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
Part 1-Arm A: Nivolumab
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
Part 1-Arm C: Chemotherapy
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
Part 1-Arm D: Nivo + Ipi
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
Part 1-Arm G: Nivo + Chemo
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
Part 1-Arm F: Chemotherapy
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
Part 2 - Arm H: Nivolumab + Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
Part 2 - Arm I: Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
Part 3 -Arm J: Nivolumab + Ipilimumab
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
Part 3 - Arm K: Chemotherapy
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
| Group | Source count |
|---|---|
| Part 1-Arm B: Nivo + Ipi | 396 |
| Part 1-Arm A: Nivolumab | 396 |
| Part 1-Arm C: Chemotherapy | 397 |
| Part 1-Arm D: Nivo + Ipi | 187 |
| Part 1-Arm G: Nivo + Chemo | 177 |
| Part 1-Arm F: Chemotherapy | 186 |
| Part 2 - Arm H: Nivolumab + Chemotherapy | 377 |
| Part 2 - Arm I: Chemotherapy | 378 |
| Part 3 -Arm J: Nivolumab + Ipilimumab | 126 |
| Part 3 - Arm K: Chemotherapy | 127 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1-Arm B: Nivo + Ipi | 36.4 | Not reported | 31.6 | 41.3 | Not reported |
| Part 1-Arm A: Nivolumab | 27.5 | Not reported | 23.2 | 32.2 | Not reported |
| Part 1-Arm C: Chemotherapy | 29.7 | Not reported | 25.3 | 34.5 | Not reported |
| Part 1-Arm D: Nivo + Ipi | 26.2 | Not reported | 20.1 | 33.1 | Not reported |
| Part 1-Arm G: Nivo + Chemo | 37.9 | Not reported | 30.7 | 45.4 | Not reported |
| Part 1-Arm F: Chemotherapy | 23.1 | Not reported | 17.3 | 29.8 | Not reported |
| Part 2 - Arm H: Nivolumab + Chemotherapy | 52.3 | Not reported | 47.1 | 57.4 | Not reported |
| Part 2 - Arm I: Chemotherapy | 29.9 | Not reported | 25.3 | 34.8 | Not reported |
| Part 3 -Arm J: Nivolumab + Ipilimumab | 38.1 | Not reported | 29.6 | 47.2 | Not reported |
| Part 3 - Arm K: Chemotherapy | 30.7 | Not reported | 22.8 | 39.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.6
- upper Limit
- 41.3
- value
- 36.4
- group Id
- OG001
- lower Limit
- 23.2
- upper Limit
- 32.2
- value
- 27.5
- group Id
- OG002
- lower Limit
- 25.3
- upper Limit
- 34.5
- value
- 29.7
- group Id
- OG003
- lower Limit
- 20.1
- upper Limit
- 33.1
- value
- 26.2
- group Id
- OG004
- lower Limit
- 30.7
- upper Limit
- 45.4
- value
- 37.9
- group Id
- OG005
- lower Limit
- 17.3
- upper Limit
- 29.8
- value
- 23.1
- group Id
- OG006
- lower Limit
- 47.1
- upper Limit
- 57.4
- value
- 52.3
- group Id
- OG007
- lower Limit
- 25.3
- upper Limit
- 34.8
- value
- 29.9
- group Id
- OG008
- lower Limit
- 29.6
- upper Limit
- 47.2
- value
- 38.1
- group Id
- OG009
- lower Limit
- 22.8
- upper Limit
- 39.5
- value
- 30.7
- denoms
- counts
- group Id
- OG000
- value
- 396
- group Id
- OG001
- value
- 396
- group Id
- OG002
- value
- 397
- group Id
- OG003
- value
- 187
- group Id
- OG004
- value
- 177
- group Id
- OG005
- value
- 186
- group Id
- OG006
- value
- 377
- group Id
- OG007
- value
- 378
- group Id
- OG008
- value
- 126
- group Id
- OG009
- value
- 127
- units
- Participants
- description
- Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Part 1-Arm B: Nivo + Ipi
- description
- Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Part 1-Arm A: Nivolumab
- description
- Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- OG002
- title
- Part 1-Arm C: Chemotherapy
- description
- Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Part 1-Arm D: Nivo + Ipi
- description
- Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- OG004
- title
- Part 1-Arm G: Nivo + Chemo
- description
- Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- OG005
- title
- Part 1-Arm F: Chemotherapy
- description
- Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- OG006
- title
- Part 2 - Arm H: Nivolumab + Chemotherapy
- description
- Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- OG007
- title
- Part 2 - Arm I: Chemotherapy
- description
- Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- OG008
- title
- Part 3 -Arm J: Nivolumab + Ipilimumab
- description
- Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
- id
- OG009
- title
- Part 3 - Arm K: Chemotherapy
- param Type
- NUMBER
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
- title
- Objective Response Rate (ORR) Per BICR
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice