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NCT02477826 · OUTCOME

Progression-Free Survival Per BICR

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2025-10-30

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 randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)

What was measured

Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1-Arm B: Nivo + Ipi396
Part 1-Arm A: Nivolumab396
Part 1-Arm C: Chemotherapy397
Part 1-Arm D: Nivo + Ipi187
Part 1-Arm G: Nivo + Chemo177
Part 1-Arm F: Chemotherapy186
Part 2 - Arm H: Nivolumab + Chemotherapy377
Part 2 - Arm I: Chemotherapy378
Part 3 -Arm J: Nivolumab + Ipilimumab126
Part 3 - Arm K: Chemotherapy127

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1-Arm B: Nivo + Ipi5.06Not reported4.076.31Not reported
Part 1-Arm A: Nivolumab4.17Not reported3.225.32Not reported
Part 1-Arm C: Chemotherapy5.55Not reported4.635.82Not reported
Part 1-Arm D: Nivo + Ipi4.90Not reported3.156.28Not reported
Part 1-Arm G: Nivo + Chemo5.55Not reported4.636.90Not reported
Part 1-Arm F: Chemotherapy4.70Not reported4.215.59Not reported
Part 2 - Arm H: Nivolumab + Chemotherapy8.34Not reported7.109.59Not reported
Part 2 - Arm I: Chemotherapy5.52Not reported4.475.85Not reported
Part 3 -Arm J: Nivolumab + Ipilimumab5.78Not reported4.148.34Not reported
Part 3 - Arm K: Chemotherapy5.49Not reported4.376.77Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.93
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.79
  2. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.12
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.95
  3. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
  4. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    group Ids
    1. OG003
    2. OG005
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    0.76
  5. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.93
    group Ids
    1. OG004
    2. OG005
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.74
  6. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.72
    group Ids
    1. OG006
    2. OG007
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.61
  7. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.89
    group Ids
    1. OG008
    2. OG009
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.66
Complete source fields
analyses
  1. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.93
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.79
  2. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.12
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.95
  3. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
  4. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    group Ids
    1. OG003
    2. OG005
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    0.76
  5. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.93
    group Ids
    1. OG004
    2. OG005
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.74
  6. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.72
    group Ids
    1. OG006
    2. OG007
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.61
  7. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.89
    group Ids
    1. OG008
    2. OG009
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.66
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.07
        upper Limit
        6.31
        value
        5.06
      2. group Id
        OG001
        lower Limit
        3.22
        upper Limit
        5.32
        value
        4.17
      3. group Id
        OG002
        lower Limit
        4.63
        upper Limit
        5.82
        value
        5.55
      4. group Id
        OG003
        lower Limit
        3.15
        upper Limit
        6.28
        value
        4.90
      5. group Id
        OG004
        lower Limit
        4.63
        upper Limit
        6.90
        value
        5.55
      6. group Id
        OG005
        lower Limit
        4.21
        upper Limit
        5.59
        value
        4.70
      7. group Id
        OG006
        lower Limit
        7.10
        upper Limit
        9.59
        value
        8.34
      8. group Id
        OG007
        lower Limit
        4.47
        upper Limit
        5.85
        value
        5.52
      9. group Id
        OG008
        lower Limit
        4.14
        upper Limit
        8.34
        value
        5.78
      10. group Id
        OG009
        lower Limit
        4.37
        upper Limit
        6.77
        value
        5.49
denoms
  1. counts
    1. group Id
      OG000
      value
      396
    2. group Id
      OG001
      value
      396
    3. group Id
      OG002
      value
      397
    4. group Id
      OG003
      value
      187
    5. group Id
      OG004
      value
      177
    6. group Id
      OG005
      value
      186
    7. group Id
      OG006
      value
      377
    8. group Id
      OG007
      value
      378
    9. group Id
      OG008
      value
      126
    10. group Id
      OG009
      value
      127
    units
    Participants
description
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
title
Progression-Free Survival Per BICR
type
PRIMARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice