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NCT04222972 · BASELINE

Baseline characteristics

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2026-03-05

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
      113
    2. group Id
      BG001
      value
      110
    3. group Id
      BG002
      value
      223
    units
    Participants
groups
  1. description
    Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
    id
    BG000
    title
    Arm A: Treatment Period- SOC
  2. description
    Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
    id
    BG001
    title
    Arm B: Treatment Period- Pralsetinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.3
          value
          62.3
        2. group Id
          BG001
          spread
          11.1
          value
          61.6
        3. group Id
          BG002
          spread
          11.7
          value
          61.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          117
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          106
        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
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          159
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          27
        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
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          16
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          43
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          133
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        Unknown
      7. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          19
        title
        Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) population included all randomized participants whether or not the assigned study treatment is received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      113
    2. group Id
      BG001
      value
      110
    3. group Id
      BG002
      value
      223
    units
    Participants
groups
  1. description
    Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
    id
    BG000
    title
    Arm A: Treatment Period- SOC
  2. description
    Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
    id
    BG001
    title
    Arm B: Treatment Period- Pralsetinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.3
          value
          62.3
        2. group Id
          BG001
          spread
          11.1
          value
          61.6
        3. group Id
          BG002
          spread
          11.7
          value
          61.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          117
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          106
        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
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          159
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          27
        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
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          16
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          43
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          133
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        Unknown
      7. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          19
        title
        Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) population included all randomized participants whether or not the assigned study treatment is received.

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Preserved source evidence · Not medical advice