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NCT00981058 · BASELINE

Baseline characteristics

First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin · Source last updated 2025-06-18

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
      545
    2. group Id
      BG001
      value
      548
    3. group Id
      BG002
      value
      1093
    units
    Participants
groups
  1. description
    Necitumumab + Gemcitabine + Cisplatin Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
    id
    BG000
    title
    Necitumumab + Gemcitabine + Cisplatin
  2. description
    Gemcitabine + Cisplatin Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
    id
    BG001
    title
    Gemcitabine + Cisplatin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          84
          value
          62.0
        2. group Id
          BG001
          lower Limit
          32
          upper Limit
          86
          value
          62.0
        3. group Id
          BG002
          lower Limit
          32
          upper Limit
          86
          value
          62.0
    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
          95
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          185
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          450
        2. group Id
          BG001
          value
          458
        3. group Id
          BG002
          value
          908
        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
          55
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          111
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          489
        2. group Id
          BG001
          value
          490
        3. group Id
          BG002
          value
          979
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          85
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
      title
      Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          457
        2. group Id
          BG001
          value
          456
        3. group Id
          BG002
          value
          913
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      More than one race
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          81
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          195
      title
      Russian Federation
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Singapore
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          36
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      Thailand
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
      title
      Portugal
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          32
      title
      Greece
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      Austria
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          58
      title
      Brazil
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          47
      title
      Korea, Republic of
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          128
      title
      Poland
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
      title
      Slovakia
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          73
      title
      France
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          164
        2. group Id
          BG001
          value
          180
        3. group Id
          BG002
          value
          344
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          332
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          652
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          96
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      3
    description
    ECOG classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 1 participant with ECOG PS 3 was randomized to the Gemcitabine + Cisplatin arm but did not receive treatment.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          44
      title
      Ex-Light Smoker
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          53
      title
      Non-Smoker
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          500
        2. group Id
          BG001
          value
          495
        3. group Id
          BG002
          value
          995
      title
      Smoker
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Smoking History
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Stage IIIB
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          543
        2. group Id
          BG001
          value
          546
        3. group Id
          BG002
          value
          1089
      title
      Stage IV
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Missing
    description
    Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIB - the cancer has spread to nearby tissue or spread to far away lymph nodes. Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver.
    param Type
    NUMBER
    title
    Disease Stage at Study Entry
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          543
        2. group Id
          BG001
          value
          545
        3. group Id
          BG002
          value
          1088
      title
      Squamous
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Other Histology
    param Type
    NUMBER
    title
    Disease Histology
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          251
      title
      Bone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          58
      title
      Brain
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          226
      title
      Liver
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          453
        2. group Id
          BG001
          value
          453
        3. group Id
          BG002
          value
          906
      title
      Lung
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          431
        2. group Id
          BG001
          value
          451
        3. group Id
          BG002
          value
          882
      title
      Lymph Nodes
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          37
      title
      Peritoneal
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          155
        3. group Id
          BG002
          value
          304
      title
      Pleural
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          17
      title
      Skin
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          44
      title
      Soft Tissue
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          302
      title
      Other
    description
    Participants may record multiple sites of metastatic disease.
    param Type
    NUMBER
    title
    Sites of Metastatic Disease
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      545
    2. group Id
      BG001
      value
      548
    3. group Id
      BG002
      value
      1093
    units
    Participants
groups
  1. description
    Necitumumab + Gemcitabine + Cisplatin Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
    id
    BG000
    title
    Necitumumab + Gemcitabine + Cisplatin
  2. description
    Gemcitabine + Cisplatin Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
    id
    BG001
    title
    Gemcitabine + Cisplatin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          84
          value
          62.0
        2. group Id
          BG001
          lower Limit
          32
          upper Limit
          86
          value
          62.0
        3. group Id
          BG002
          lower Limit
          32
          upper Limit
          86
          value
          62.0
    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
          95
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          185
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          450
        2. group Id
          BG001
          value
          458
        3. group Id
          BG002
          value
          908
        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
          55
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          111
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          489
        2. group Id
          BG001
          value
          490
        3. group Id
          BG002
          value
          979
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          85
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
      title
      Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          457
        2. group Id
          BG001
          value
          456
        3. group Id
          BG002
          value
          913
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      More than one race
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          81
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          195
      title
      Russian Federation
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Singapore
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          36
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      Thailand
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
      title
      Portugal
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          32
      title
      Greece
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
      title
      Austria
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          58
      title
      Brazil
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          47
      title
      Korea, Republic of
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          128
      title
      Poland
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
      title
      Slovakia
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          73
      title
      France
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          164
        2. group Id
          BG001
          value
          180
        3. group Id
          BG002
          value
          344
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          332
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          652
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          96
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      3
    description
    ECOG classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 1 participant with ECOG PS 3 was randomized to the Gemcitabine + Cisplatin arm but did not receive treatment.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          44
      title
      Ex-Light Smoker
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          53
      title
      Non-Smoker
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          500
        2. group Id
          BG001
          value
          495
        3. group Id
          BG002
          value
          995
      title
      Smoker
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Smoking History
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Stage IIIB
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          543
        2. group Id
          BG001
          value
          546
        3. group Id
          BG002
          value
          1089
      title
      Stage IV
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Missing
    description
    Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIB - the cancer has spread to nearby tissue or spread to far away lymph nodes. Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver.
    param Type
    NUMBER
    title
    Disease Stage at Study Entry
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          543
        2. group Id
          BG001
          value
          545
        3. group Id
          BG002
          value
          1088
      title
      Squamous
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Other Histology
    param Type
    NUMBER
    title
    Disease Histology
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          251
      title
      Bone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          58
      title
      Brain
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          226
      title
      Liver
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          453
        2. group Id
          BG001
          value
          453
        3. group Id
          BG002
          value
          906
      title
      Lung
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          431
        2. group Id
          BG001
          value
          451
        3. group Id
          BG002
          value
          882
      title
      Lymph Nodes
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          37
      title
      Peritoneal
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          155
        3. group Id
          BG002
          value
          304
      title
      Pleural
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          17
      title
      Skin
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          44
      title
      Soft Tissue
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          302
      title
      Other
    description
    Participants may record multiple sites of metastatic disease.
    param Type
    NUMBER
    title
    Sites of Metastatic Disease
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice