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NCT03041311 · BASELINE

Baseline characteristics

Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC · Source last updated 2025-09-25

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
      54
    2. group Id
      BG001
      value
      53
    3. group Id
      BG002
      value
      107
    units
    Participants
groups
  1. description
    Induction: Patients received trilaciclib 240 mg/m² administered IV once daily on Days prior to E/P/A 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
    id
    BG000
    title
    Trilaciclib+Etoposide/Carboplatin/Atezolizumab
  2. description
    Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.
    id
    BG001
    title
    Placebo+Etoposide/Carboplatin/Atezolizumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          54
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          53
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.4
          value
          63
        2. group Id
          BG001
          spread
          8.3
          value
          64
        3. group Id
          BG002
          spread
          8.3
          value
          64
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          32
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          75
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          104
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      Latvia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          42
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          19
      title
      Ukraine
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
      title
      Bulgaria
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      France
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Estonia
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          16
      title
      Georgia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.32
          value
          79.2
        2. group Id
          BG001
          spread
          14.42
          value
          72.4
        3. group Id
          BG002
          spread
          16.25
          value
          75.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Weight at Screening
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.62
          value
          171.1
        2. group Id
          BG001
          spread
          10.21
          value
          168.6
        3. group Id
          BG002
          spread
          9.04
          value
          169.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height at Screening
    unit Of Measure
    cm
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.907
          value
          27.10
        2. group Id
          BG001
          spread
          4.618
          value
          25.45
        3. group Id
          BG002
          spread
          5.347
          value
          26.28
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BMI at Screening
    unit Of Measure
    kg/m²
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.198
          value
          1.91
        2. group Id
          BG001
          spread
          0.205
          value
          1.82
        3. group Id
          BG002
          spread
          0.205
          value
          1.86
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (m²) at Screening
    unit Of Measure
    m²
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          92
      title
      0-1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
      title
      2
    description
    The publicly available Easter Cooperative Oncology Group (ECOG) Performance Status Scale was utilized to assess patient level of functioning. Increasing numbers indicate worse outcomes. GRADE ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      54
    2. group Id
      BG001
      value
      53
    3. group Id
      BG002
      value
      107
    units
    Participants
groups
  1. description
    Induction: Patients received trilaciclib 240 mg/m² administered IV once daily on Days prior to E/P/A 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
    id
    BG000
    title
    Trilaciclib+Etoposide/Carboplatin/Atezolizumab
  2. description
    Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.
    id
    BG001
    title
    Placebo+Etoposide/Carboplatin/Atezolizumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          54
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          53
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.4
          value
          63
        2. group Id
          BG001
          spread
          8.3
          value
          64
        3. group Id
          BG002
          spread
          8.3
          value
          64
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          32
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          75
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          104
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      Latvia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          42
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          19
      title
      Ukraine
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
      title
      Bulgaria
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      France
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Estonia
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          16
      title
      Georgia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.32
          value
          79.2
        2. group Id
          BG001
          spread
          14.42
          value
          72.4
        3. group Id
          BG002
          spread
          16.25
          value
          75.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Weight at Screening
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.62
          value
          171.1
        2. group Id
          BG001
          spread
          10.21
          value
          168.6
        3. group Id
          BG002
          spread
          9.04
          value
          169.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height at Screening
    unit Of Measure
    cm
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.907
          value
          27.10
        2. group Id
          BG001
          spread
          4.618
          value
          25.45
        3. group Id
          BG002
          spread
          5.347
          value
          26.28
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BMI at Screening
    unit Of Measure
    kg/m²
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.198
          value
          1.91
        2. group Id
          BG001
          spread
          0.205
          value
          1.82
        3. group Id
          BG002
          spread
          0.205
          value
          1.86
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (m²) at Screening
    unit Of Measure
    m²
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          92
      title
      0-1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
      title
      2
    description
    The publicly available Easter Cooperative Oncology Group (ECOG) Performance Status Scale was utilized to assess patient level of functioning. Increasing numbers indicate worse outcomes. GRADE ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice