NCT03215706 · OUTCOME
OS by PD-L1 Tumor Cell Expression
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 to date of death (assessed up to October 2024, approximately 72 months)
What was measured
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
Analysis population: All Randomized Participants, Global Population with PD-L1 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 | 360 |
|---|
| Treatment B | 358 |
|---|
Reported measurements
< 1% PD-L1 Expression
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 135 |
|---|
| Treatment B | 129 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 17.74 | Not reported | 13.67 | 20.27 | Not reported |
|---|
| Treatment B | 9.79 | Not reported | 7.69 | 13.54 | Not reported |
|---|
>= 1% PD-L1 Expression
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 204 |
|---|
| Treatment B | 204 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 15.80 | Not reported | 13.77 | 22.18 | Not reported |
|---|
| Treatment B | 10.89 | Not reported | 9.49 | 13.17 | Not reported |
|---|
with 1-49% PD-L1 Expression
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 128 |
|---|
| Treatment B | 106 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 15.20 | Not reported | 12.62 | 21.22 | Not reported |
|---|
| Treatment B | 10.37 | Not reported | 8.67 | 12.35 | Not reported |
|---|
with >= 50% PD-L1 Expression
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 76 |
|---|
| Treatment B | 98 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 18.91 | Not reported | 13.11 | 29.11 | Not reported |
|---|
| Treatment B | 12.93 | Not reported | 9.36 | 17.58 | Not reported |
|---|
Non-Quantifiable PD-L1 Expression
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A | 21 |
|---|
| Treatment B | 25 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A | 10.84 | Not reported | 7.16 | 15.57 | Not reported |
|---|
| Treatment B | 17.05 | Not reported | 8.64 | NA | Upper Limit Not Reached |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.67
- upper Limit
- 20.27
- value
- 17.74
- group Id
- OG001
- lower Limit
- 7.69
- upper Limit
- 13.54
- value
- 9.79
- denoms
- counts
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 129
- units
- Participants
- title
- < 1% PD-L1 Expression
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.77
- upper Limit
- 22.18
- value
- 15.80
- group Id
- OG001
- lower Limit
- 9.49
- upper Limit
- 13.17
- value
- 10.89
- denoms
- counts
- group Id
- OG000
- value
- 204
- group Id
- OG001
- value
- 204
- units
- Participants
- title
- >= 1% PD-L1 Expression
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.62
- upper Limit
- 21.22
- value
- 15.20
- group Id
- OG001
- lower Limit
- 8.67
- upper Limit
- 12.35
- value
- 10.37
- denoms
- counts
- group Id
- OG000
- value
- 128
- group Id
- OG001
- value
- 106
- units
- Participants
- title
- with 1-49% PD-L1 Expression
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.11
- upper Limit
- 29.11
- value
- 18.91
- group Id
- OG001
- lower Limit
- 9.36
- upper Limit
- 17.58
- value
- 12.93
- denoms
- counts
- group Id
- OG000
- value
- 76
- group Id
- OG001
- value
- 98
- units
- Participants
- title
- with >= 50% PD-L1 Expression
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.16
- upper Limit
- 15.57
- value
- 10.84
- comment
- Upper Limit Not Reached
- group Id
- OG001
- lower Limit
- 8.64
- upper Limit
- NA
- value
- 17.05
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 25
- units
- Participants
- title
- Non-Quantifiable PD-L1 Expression
- denoms
- counts
- group Id
- OG000
- value
- 360
- group Id
- OG001
- value
- 358
- units
- Participants
- description
- OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
- 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 PD-L1 measurements
- reporting Status
- POSTED
- time Frame
- From date of randomization to date of death (assessed up to October 2024, approximately 72 months)
- title
- OS by PD-L1 Tumor Cell Expression
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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