NCT03215706 · OUTCOME
ORR by BICR by Tumor Mutational Burden
A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC · Source last updated 2025-12-17
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 date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
What was measured
ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.
Analysis population: All Randomized Participants, Global Population with tumor mutational burden measurements
Groups in this outcome
Treatment A
Nivolumab + Ipilimumab + Chemotherapy
Treatment B
Chemotherapy only
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 355 |
|---|
| Treatment B | 356 |
|---|
Reported measurements
≥ 10 Mutations/MB
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 101 |
|---|
| Treatment B | 82 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 45.5 | Not reported | 35.6 | 55.8 | Not reported |
|---|
| Treatment B | 29.3 | Not reported | 19.7 | 40.4 | Not reported |
|---|
< 10 Mutations/MB
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 136 |
|---|
| Treatment B | 137 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 31.6 | Not reported | 23.9 | 40.1 | Not reported |
|---|
| Treatment B | 27.0 | Not reported | 19.8 | 35.3 | Not reported |
|---|
Overall
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 237 |
|---|
| Treatment B | 219 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 37.6 | Not reported | 31.4 | 44.1 | Not reported |
|---|
| Treatment B | 27.9 | Not reported | 22.0 | 34.3 | Not reported |
|---|
Not Evaluable
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 118 |
|---|
| Treatment B | 137 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 36.4 | Not reported | 27.8 | 45.8 | Not reported |
|---|
| Treatment B | 21.2 | Not reported | 14.7 | 29.0 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.6
- upper Limit
- 55.8
- value
- 45.5
- group Id
- OG001
- lower Limit
- 19.7
- upper Limit
- 40.4
- value
- 29.3
- denoms
- counts
- group Id
- OG000
- value
- 101
- group Id
- OG001
- value
- 82
- units
- Participants
- title
- ≥ 10 Mutations/MB
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.9
- upper Limit
- 40.1
- value
- 31.6
- group Id
- OG001
- lower Limit
- 19.8
- upper Limit
- 35.3
- value
- 27.0
- denoms
- counts
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 137
- units
- Participants
- title
- < 10 Mutations/MB
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.4
- upper Limit
- 44.1
- value
- 37.6
- group Id
- OG001
- lower Limit
- 22.0
- upper Limit
- 34.3
- value
- 27.9
- denoms
- counts
- group Id
- OG000
- value
- 237
- group Id
- OG001
- value
- 219
- units
- Participants
- title
- Overall
- categories
- measurements
- group Id
- OG000
- lower Limit
- 27.8
- upper Limit
- 45.8
- value
- 36.4
- group Id
- OG001
- lower Limit
- 14.7
- upper Limit
- 29.0
- value
- 21.2
- denoms
- counts
- group Id
- OG000
- value
- 118
- group Id
- OG001
- value
- 137
- units
- Participants
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 355
- group Id
- OG001
- value
- 356
- units
- Participants
- description
- ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab + Ipilimumab + Chemotherapy
- id
- OG000
- title
- Treatment A
- description
- Chemotherapy only
- id
- OG001
- title
- Treatment B
- param Type
- NUMBER
- population Description
- All Randomized Participants, Global Population with tumor mutational burden measurements
- reporting Status
- POSTED
- time Frame
- From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
- title
- ORR by BICR by Tumor Mutational Burden
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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