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NCT04194944 · BASELINE

Baseline characteristics

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer · Source last updated 2025-10-21

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
      159
    2. group Id
      BG001
      value
      102
    3. group Id
      BG002
      value
      261
    units
    Participants
groups
  1. description
    160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
    id
    BG000
    title
    Selpercatinib (TRT A)
  2. description
    Pemetrexed 500 mg/m2, IV on Day 1 Q3W plus investigator's choice of carboplatin (AUC 5 \[maximum dose 750 mg\] IV) or cisplatin 75mg/m2, IV on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
    id
    BG001
    title
    Pemetrexed and Platinum With or Without Pembrolizumab (TRT B)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.3
          value
          60.2
        2. group Id
          BG001
          spread
          11.4
          value
          60.8
        3. group Id
          BG002
          spread
          11.3
          value
          60.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          143
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          118
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          144
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          101
        title
        White
      6. 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. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
      title
      Hong Kong
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Czechia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Russia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Greece
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Netherlands
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      South Korea
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          90
      title
      China
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
      title
      Brazil
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Poland
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      title
      France
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Argentina
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          25
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Intent to Treat Population (ITT): All randomized participants, even if a participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      159
    2. group Id
      BG001
      value
      102
    3. group Id
      BG002
      value
      261
    units
    Participants
groups
  1. description
    160 mg Selpercatinib administered orally BID continuously in 21-day cycles.
    id
    BG000
    title
    Selpercatinib (TRT A)
  2. description
    Pemetrexed 500 mg/m2, IV on Day 1 Q3W plus investigator's choice of carboplatin (AUC 5 \[maximum dose 750 mg\] IV) or cisplatin 75mg/m2, IV on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
    id
    BG001
    title
    Pemetrexed and Platinum With or Without Pembrolizumab (TRT B)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.3
          value
          60.2
        2. group Id
          BG001
          spread
          11.4
          value
          60.8
        3. group Id
          BG002
          spread
          11.3
          value
          60.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          143
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          118
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          144
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          101
        title
        White
      6. 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. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
      title
      Hong Kong
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Czechia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Russia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Greece
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Netherlands
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      South Korea
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          90
      title
      China
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
      title
      Brazil
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Poland
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      title
      France
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Argentina
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          25
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Intent to Treat Population (ITT): All randomized participants, even if a participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

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Preserved source evidence · Not medical advice