NCT01642004 · OUTCOME
Progression Free Survival Rate (PFSR)
Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017) · Source last updated 2022-12-28
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 to specified timepoints, up to 84 months
What was measured
PFSR was defined as the percentage of participants who did not experience disease progression or death from any cause at a given time point following randomization. Progression was assessed by investigators according to RECIST v1.1. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative radiation therapy (RT) of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.
Analysis population: All randomized participants
Groups in this outcome
Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
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 |
|---|
| Nivolumab | 135 |
|---|
| Docetaxel | 137 |
|---|
Reported measurements
6 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 38.4 | Not reported | 30.0 | 46.8 | Not reported |
|---|
| Docetaxel | 22.6 | Not reported | 15.7 | 30.2 | Not reported |
|---|
12 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 21.0 | Not reported | 14.3 | 28.6 | Not reported |
|---|
| Docetaxel | 7.2 | Not reported | 3.4 | 12.8 | Not reported |
|---|
18 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 15.87 | Not reported | 9.9 | 22.8 | Not reported |
|---|
| Docetaxel | 1.8 | Not reported | 0.4 | 5.7 | Not reported |
|---|
24 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 14.8 | Not reported | 9.1 | 21.8 | Not reported |
|---|
| Docetaxel | NA | Not reported | NA | NA | Median, lower and upper limit not reached due to insufficient number of events. |
|---|
36 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 11.0 | Not reported | 6.1 | 17.5 | Not reported |
|---|
| Docetaxel | NA | Not reported | NA | NA | Median, lower and upper limit not reached due to insufficient number of events. |
|---|
48 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 8.9 | Not reported | 4.5 | 15.1 | Not reported |
|---|
| Docetaxel | NA | Not reported | NA | NA | Median, lower and upper limit not reached due to insufficient number of events. |
|---|
60 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 8.9 | Not reported | 4.5 | 15.1 | Not reported |
|---|
| Docetaxel | NA | Not reported | NA | NA | Median, lower and upper limit not reached due to insufficient number of events. |
|---|
72 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 7.6 | Not reported | 3.5 | 13.7 | Not reported |
|---|
| Docetaxel | NA | Not reported | NA | NA | Median, lower and upper limit not reached due to insufficient number of events. |
|---|
84 months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 6.1 | Not reported | 2.4 | 12.2 | Not reported |
|---|
| Docetaxel | NA | Not reported | NA | NA | Median, lower and upper limit not reached due to insufficient number of events. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.0
- upper Limit
- 46.8
- value
- 38.4
- group Id
- OG001
- lower Limit
- 15.7
- upper Limit
- 30.2
- value
- 22.6
- title
- 6 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.3
- upper Limit
- 28.6
- value
- 21.0
- group Id
- OG001
- lower Limit
- 3.4
- upper Limit
- 12.8
- value
- 7.2
- title
- 12 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.9
- upper Limit
- 22.8
- value
- 15.87
- group Id
- OG001
- lower Limit
- 0.4
- upper Limit
- 5.7
- value
- 1.8
- title
- 18 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.1
- upper Limit
- 21.8
- value
- 14.8
- comment
- Median, lower and upper limit not reached due to insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- 24 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.1
- upper Limit
- 17.5
- value
- 11.0
- comment
- Median, lower and upper limit not reached due to insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- 36 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- 15.1
- value
- 8.9
- comment
- Median, lower and upper limit not reached due to insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- 48 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- 15.1
- value
- 8.9
- comment
- Median, lower and upper limit not reached due to insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- 60 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.5
- upper Limit
- 13.7
- value
- 7.6
- comment
- Median, lower and upper limit not reached due to insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- 72 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.4
- upper Limit
- 12.2
- value
- 6.1
- comment
- Median, lower and upper limit not reached due to insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- 84 months
- denoms
- counts
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 137
- units
- Participants
- description
- PFSR was defined as the percentage of participants who did not experience disease progression or death from any cause at a given time point following randomization. Progression was assessed by investigators according to RECIST v1.1. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative radiation therapy (RT) of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
- id
- OG000
- title
- Nivolumab
- description
- Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
- id
- OG001
- title
- Docetaxel
- param Type
- NUMBER
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization to specified timepoints, up to 84 months
- title
- Progression Free Survival Rate (PFSR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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