TriangleNCT02477826 · OUTCOME
Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale
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
- Week 12
What was measured
The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
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 | 31.3 | Not reported | 26.8 | 36.1 | Not reported |
| Part 1-Arm A: Nivolumab | 35.4 | Not reported | 30.6 | 40.3 | Not reported |
| Part 1-Arm C: Chemotherapy | 25.7 | Not reported | 21.5 | 30.3 | Not reported |
| Part 1-Arm D: Nivo + Ipi | 33.2 | Not reported | 26.5 | 40.4 | Not reported |
| Part 1-Arm G: Nivo + Chemo | 28.8 | Not reported | 22.3 | 36.1 | Not reported |
| Part 1-Arm F: Chemotherapy | 37.6 | Not reported | 30.7 | 45.0 | Not reported |
| Part 2 - Arm H: Nivolumab + Chemotherapy | 30.0 | Not reported | 25.4 | 34.9 | Not reported |
| Part 2 - Arm I: Chemotherapy | 24.3 | Not reported | 20.1 | 29.0 | Not reported |
| Part 3 -Arm J: Nivolumab + Ipilimumab | 23.0 | Not reported | 16.0 | 31.4 | Not reported |
| Part 3 - Arm K: Chemotherapy | 26.0 | Not reported | 18.6 | 34.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.8
- upper Limit
- 36.1
- value
- 31.3
- group Id
- OG001
- lower Limit
- 30.6
- upper Limit
- 40.3
- value
- 35.4
- group Id
- OG002
- lower Limit
- 21.5
- upper Limit
- 30.3
- value
- 25.7
- group Id
- OG003
- lower Limit
- 26.5
- upper Limit
- 40.4
- value
- 33.2
- group Id
- OG004
- lower Limit
- 22.3
- upper Limit
- 36.1
- value
- 28.8
- group Id
- OG005
- lower Limit
- 30.7
- upper Limit
- 45.0
- value
- 37.6
- group Id
- OG006
- lower Limit
- 25.4
- upper Limit
- 34.9
- value
- 30.0
- group Id
- OG007
- lower Limit
- 20.1
- upper Limit
- 29.0
- value
- 24.3
- group Id
- OG008
- lower Limit
- 16.0
- upper Limit
- 31.4
- value
- 23.0
- group Id
- OG009
- lower Limit
- 18.6
- upper Limit
- 34.5
- value
- 26.0
- 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
- The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
- 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
- Week 12
- title
- Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice