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NCT02477826 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      396
    2. group Id
      BG001
      value
      396
    3. group Id
      BG002
      value
      397
    4. group Id
      BG003
      value
      187
    5. group Id
      BG004
      value
      177
    6. group Id
      BG005
      value
      186
    7. group Id
      BG006
      value
      377
    8. group Id
      BG007
      value
      378
    9. group Id
      BG008
      value
      126
    10. group Id
      BG009
      value
      127
    11. group Id
      BG010
      value
      2747
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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
    BG003
    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
    BG004
    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
    BG005
    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
    BG006
    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
    BG007
    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
    BG008
    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
    BG009
    title
    Part 3 - Arm K: Chemotherapy
  11. description
    Total of all reporting groups
    id
    BG010
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          207
        4. group Id
          BG003
          value
          107
        5. group Id
          BG004
          value
          91
        6. group Id
          BG005
          value
          98
        7. group Id
          BG006
          value
          214
        8. group Id
          BG007
          value
          196
        9. group Id
          BG008
          value
          82
        10. group Id
          BG009
          value
          84
        11. group Id
          BG010
          value
          1488
        title
        < 65
      2. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          186
        3. group Id
          BG002
          value
          190
        4. group Id
          BG003
          value
          80
        5. group Id
          BG004
          value
          86
        6. group Id
          BG005
          value
          88
        7. group Id
          BG006
          value
          163
        8. group Id
          BG007
          value
          182
        9. group Id
          BG008
          value
          44
        10. group Id
          BG009
          value
          43
        11. group Id
          BG010
          value
          1259
        title
        =>65
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          137
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          47
        6. group Id
          BG005
          value
          61
        7. group Id
          BG006
          value
          113
        8. group Id
          BG007
          value
          115
        9. group Id
          BG008
          value
          18
        10. group Id
          BG009
          value
          20
        11. group Id
          BG010
          value
          825
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          255
        2. group Id
          BG001
          value
          272
        3. group Id
          BG002
          value
          260
        4. group Id
          BG003
          value
          138
        5. group Id
          BG004
          value
          130
        6. group Id
          BG005
          value
          125
        7. group Id
          BG006
          value
          264
        8. group Id
          BG007
          value
          263
        9. group Id
          BG008
          value
          108
        10. group Id
          BG009
          value
          107
        11. group Id
          BG010
          value
          1922
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          299
        2. group Id
          BG001
          value
          317
        3. group Id
          BG002
          value
          305
        4. group Id
          BG003
          value
          143
        5. group Id
          BG004
          value
          136
        6. group Id
          BG005
          value
          133
        7. group Id
          BG006
          value
          272
        8. group Id
          BG007
          value
          266
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1871
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          23
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          82
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          38
        6. group Id
          BG005
          value
          45
        7. group Id
          BG006
          value
          93
        8. group Id
          BG007
          value
          94
        9. group Id
          BG008
          value
          126
        10. group Id
          BG009
          value
          127
        11. group Id
          BG010
          value
          797
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          41
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          13
        title
        American Indian or Alaska Native
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        title
        Native Hawaiian or other pacific islander
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        title
        Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      396
    2. group Id
      BG001
      value
      396
    3. group Id
      BG002
      value
      397
    4. group Id
      BG003
      value
      187
    5. group Id
      BG004
      value
      177
    6. group Id
      BG005
      value
      186
    7. group Id
      BG006
      value
      377
    8. group Id
      BG007
      value
      378
    9. group Id
      BG008
      value
      126
    10. group Id
      BG009
      value
      127
    11. group Id
      BG010
      value
      2747
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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
    BG003
    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
    BG004
    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
    BG005
    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
    BG006
    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
    BG007
    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
    BG008
    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
    BG009
    title
    Part 3 - Arm K: Chemotherapy
  11. description
    Total of all reporting groups
    id
    BG010
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          207
        4. group Id
          BG003
          value
          107
        5. group Id
          BG004
          value
          91
        6. group Id
          BG005
          value
          98
        7. group Id
          BG006
          value
          214
        8. group Id
          BG007
          value
          196
        9. group Id
          BG008
          value
          82
        10. group Id
          BG009
          value
          84
        11. group Id
          BG010
          value
          1488
        title
        < 65
      2. measurements
        1. group Id
          BG000
          value
          197
        2. group Id
          BG001
          value
          186
        3. group Id
          BG002
          value
          190
        4. group Id
          BG003
          value
          80
        5. group Id
          BG004
          value
          86
        6. group Id
          BG005
          value
          88
        7. group Id
          BG006
          value
          163
        8. group Id
          BG007
          value
          182
        9. group Id
          BG008
          value
          44
        10. group Id
          BG009
          value
          43
        11. group Id
          BG010
          value
          1259
        title
        =>65
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          137
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          47
        6. group Id
          BG005
          value
          61
        7. group Id
          BG006
          value
          113
        8. group Id
          BG007
          value
          115
        9. group Id
          BG008
          value
          18
        10. group Id
          BG009
          value
          20
        11. group Id
          BG010
          value
          825
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          255
        2. group Id
          BG001
          value
          272
        3. group Id
          BG002
          value
          260
        4. group Id
          BG003
          value
          138
        5. group Id
          BG004
          value
          130
        6. group Id
          BG005
          value
          125
        7. group Id
          BG006
          value
          264
        8. group Id
          BG007
          value
          263
        9. group Id
          BG008
          value
          108
        10. group Id
          BG009
          value
          107
        11. group Id
          BG010
          value
          1922
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          299
        2. group Id
          BG001
          value
          317
        3. group Id
          BG002
          value
          305
        4. group Id
          BG003
          value
          143
        5. group Id
          BG004
          value
          136
        6. group Id
          BG005
          value
          133
        7. group Id
          BG006
          value
          272
        8. group Id
          BG007
          value
          266
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1871
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          23
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          82
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          38
        6. group Id
          BG005
          value
          45
        7. group Id
          BG006
          value
          93
        8. group Id
          BG007
          value
          94
        9. group Id
          BG008
          value
          126
        10. group Id
          BG009
          value
          127
        11. group Id
          BG010
          value
          797
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          41
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          13
        title
        American Indian or Alaska Native
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        title
        Native Hawaiian or other pacific islander
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        title
        Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice