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NCT03409614 · BASELINE

Baseline characteristics

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer · Source last updated 2026-05-18

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
      108
    2. group Id
      BG001
      value
      109
    3. group Id
      BG002
      value
      106
    4. group Id
      BG003
      value
      312
    5. group Id
      BG004
      value
      154
    6. group Id
      BG005
      value
      789
    units
    Participants
groups
  1. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy
    id
    BG000
    title
    Part 1: Cemiplimab + Chemotherapy
  2. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy and ipilimumab
    id
    BG001
    title
    Part 1: Cemiplimab+AbbrevChemo+Ipilimumab
  3. description
    Participants received platinum-based doublet chemotherapy
    id
    BG002
    title
    Part 1: Chemotherapy
  4. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy
    id
    BG003
    title
    Part 2: Cemiplimab + Chemotherapy
  5. description
    Placebo matching cemiplimab plus platinum-based doublet chemotherapy
    id
    BG004
    title
    Part 2: Placebo + Chemotherapy
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          87
          value
          63.0
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          85
          value
          64.0
        3. group Id
          BG002
          lower Limit
          40
          upper Limit
          81
          value
          63.0
        4. group Id
          BG003
          lower Limit
          25
          upper Limit
          82
          value
          63.0
        5. group Id
          BG004
          lower Limit
          34
          upper Limit
          84
          value
          63.0
        6. group Id
          BG005
          lower Limit
          25
          upper Limit
          87
          value
          63.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          44
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          125
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          93
        4. group Id
          BG003
          value
          268
        5. group Id
          BG004
          value
          123
        6. group Id
          BG005
          value
          664
        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
          91
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          91
        4. group Id
          BG003
          value
          267
        5. group Id
          BG004
          value
          138
        6. group Id
          BG005
          value
          684
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          86
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        Not reported
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          17
        title
        Missing
    description
    Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        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
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          98
        4. group Id
          BG003
          value
          311
        5. group Id
          BG004
          value
          149
        6. group Id
          BG005
          value
          763
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          7
        title
        Not reported
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          17
        title
        Missing
    description
    Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS) included all participants to whom study treatment had been assigned by randomization in each study part.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      108
    2. group Id
      BG001
      value
      109
    3. group Id
      BG002
      value
      106
    4. group Id
      BG003
      value
      312
    5. group Id
      BG004
      value
      154
    6. group Id
      BG005
      value
      789
    units
    Participants
groups
  1. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy
    id
    BG000
    title
    Part 1: Cemiplimab + Chemotherapy
  2. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy and ipilimumab
    id
    BG001
    title
    Part 1: Cemiplimab+AbbrevChemo+Ipilimumab
  3. description
    Participants received platinum-based doublet chemotherapy
    id
    BG002
    title
    Part 1: Chemotherapy
  4. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy
    id
    BG003
    title
    Part 2: Cemiplimab + Chemotherapy
  5. description
    Placebo matching cemiplimab plus platinum-based doublet chemotherapy
    id
    BG004
    title
    Part 2: Placebo + Chemotherapy
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          87
          value
          63.0
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          85
          value
          64.0
        3. group Id
          BG002
          lower Limit
          40
          upper Limit
          81
          value
          63.0
        4. group Id
          BG003
          lower Limit
          25
          upper Limit
          82
          value
          63.0
        5. group Id
          BG004
          lower Limit
          34
          upper Limit
          84
          value
          63.0
        6. group Id
          BG005
          lower Limit
          25
          upper Limit
          87
          value
          63.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          44
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          125
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          93
        4. group Id
          BG003
          value
          268
        5. group Id
          BG004
          value
          123
        6. group Id
          BG005
          value
          664
        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
          91
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          91
        4. group Id
          BG003
          value
          267
        5. group Id
          BG004
          value
          138
        6. group Id
          BG005
          value
          684
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          86
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        Not reported
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          17
        title
        Missing
    description
    Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        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
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          98
        4. group Id
          BG003
          value
          311
        5. group Id
          BG004
          value
          149
        6. group Id
          BG005
          value
          763
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          7
        title
        Not reported
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          17
        title
        Missing
    description
    Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS) included all participants to whom study treatment had been assigned by randomization in each study part.

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Preserved source evidence · Not medical advice