NCT03215706 · OUTCOME
PFS 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
- MEDIAN
- Unit
- Months
- 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
PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
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 Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 8.94 | Not reported | 5.55 | 13.01 | Not reported |
|---|
| Treatment B | 4.70 | Not reported | 4.14 | 5.62 | Not reported |
|---|
< 10 Mutations/MB
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 136 |
|---|
| Treatment B | 137 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 5.62 | Not reported | 4.17 | 7.20 | Not reported |
|---|
| Treatment B | 5.16 | Not reported | 4.21 | 5.62 | Not reported |
|---|
Overall
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 237 |
|---|
| Treatment B | 219 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 6.37 | Not reported | 5.36 | 8.21 | Not reported |
|---|
| Treatment B | 4.96 | Not reported | 4.27 | 5.55 | Not reported |
|---|
Not Evaluable
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 118 |
|---|
| Treatment B | 137 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 6.74 | Not reported | 4.24 | 9.69 | Not reported |
|---|
| Treatment B | 5.45 | Not reported | 4.17 | 5.82 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.55
- upper Limit
- 13.01
- value
- 8.94
- group Id
- OG001
- lower Limit
- 4.14
- upper Limit
- 5.62
- value
- 4.70
- 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
- 4.17
- upper Limit
- 7.20
- value
- 5.62
- group Id
- OG001
- lower Limit
- 4.21
- upper Limit
- 5.62
- value
- 5.16
- 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
- 5.36
- upper Limit
- 8.21
- value
- 6.37
- group Id
- OG001
- lower Limit
- 4.27
- upper Limit
- 5.55
- value
- 4.96
- denoms
- counts
- group Id
- OG000
- value
- 237
- group Id
- OG001
- value
- 219
- units
- Participants
- title
- Overall
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.24
- upper Limit
- 9.69
- value
- 6.74
- group Id
- OG001
- lower Limit
- 4.17
- upper Limit
- 5.82
- value
- 5.45
- 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
- PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
- 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
- MEDIAN
- 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
- PFS by BICR by Tumor Mutational Burden
- type
- SECONDARY
- unit Of Measure
- Months
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