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NCT04035486 · BASELINE

Baseline characteristics

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2) · Source last updated 2026-09-03

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
      15
    2. group Id
      BG001
      value
      15
    3. group Id
      BG002
      value
      279
    4. group Id
      BG003
      value
      278
    5. group Id
      BG004
      value
      587
    units
    Participants
groups
  1. description
    Osimertinib (AZD9291) 80 mg once daily (QD) with Carboplatin (AUC of 5 mg/mL/min \[AUC5\]) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W
    id
    BG000
    title
    Safety Run-In: AZD9291 + Carboplatin + Pemetrexed
  2. description
    Osimertinib (AZD9291) 80 mg once daily (QD) with Cisplatin (75 mg/m2) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W
    id
    BG001
    title
    Safety Run-In: AZD9291 + Cisplatin + Pemetrexed
  3. description
    Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
    id
    BG002
    title
    Randomized: AZD9291 + Chemo
  4. description
    Osimertinib (AZD9291) 80mg QD.
    id
    BG003
    title
    Randomized: AZD9291
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.82
          value
          62.4
        2. group Id
          BG001
          spread
          8.36
          value
          60.4
        3. group Id
          BG002
          spread
          10.03
          value
          61.0
        4. group Id
          BG003
          spread
          10.57
          value
          60.7
        5. group Id
          BG004
          spread
          10.3
          value
          60.9
      title
      Age (Years)
    description
    Age in Years at study entry
    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
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          44
        5. group Id
          BG004
          value
          88
        title
        <50
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          136
        4. group Id
          BG003
          value
          122
        5. group Id
          BG004
          value
          270
        title
        >=50-<65
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          82
        4. group Id
          BG003
          value
          88
        5. group Id
          BG004
          value
          179
        title
        >=65-<75
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          50
        title
        >=75
      title
      Age Group
    description
    Age Groups in Years at study entry
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          173
        4. group Id
          BG003
          value
          169
        5. group Id
          BG004
          value
          361
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          106
        4. group Id
          BG003
          value
          109
        5. group Id
          BG004
          value
          226
        title
        Male
      title
      Sex
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          68
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          239
        4. group Id
          BG003
          value
          248
        5. group Id
          BG004
          value
          517
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        title
        Unknown or Not Reported
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        title
        Black or African American
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or other Pacific Islander
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          17
        title
        American Indian or Alaska Native
      4. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          179
        4. group Id
          BG003
          value
          176
        5. group Id
          BG004
          value
          377
        title
        Asian
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          74
        4. group Id
          BG003
          value
          83
        5. group Id
          BG004
          value
          165
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          23
        title
        Other
      title
      Race
    description
    Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          108
        4. group Id
          BG003
          value
          107
        5. group Id
          BG004
          value
          231
        title
        Asian, not specified
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          71
        4. group Id
          BG003
          value
          69
        5. group Id
          BG004
          value
          146
        title
        Chinese
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          99
        4. group Id
          BG003
          value
          100
        5. group Id
          BG004
          value
          207
        title
        Other ethnic population (Non-Asian)
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        title
        Missing
      title
      Ethnic Population
    description
    Ethnic population
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Safety Run-In treatment arms are based on the Safety set, which includes all participants allocated to the safety run-in group of this study and who receive at least 1 dose of study treatment (Osimertinib, Cisplatin, Carboplatin, or Pemetrexed). The Randomized treatment arms are based on the Full Analysis set, which includes all participants allocated to the randomized group of this study and who were randomized to a treatment arm.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      15
    2. group Id
      BG001
      value
      15
    3. group Id
      BG002
      value
      279
    4. group Id
      BG003
      value
      278
    5. group Id
      BG004
      value
      587
    units
    Participants
groups
  1. description
    Osimertinib (AZD9291) 80 mg once daily (QD) with Carboplatin (AUC of 5 mg/mL/min \[AUC5\]) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W
    id
    BG000
    title
    Safety Run-In: AZD9291 + Carboplatin + Pemetrexed
  2. description
    Osimertinib (AZD9291) 80 mg once daily (QD) with Cisplatin (75 mg/m2) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W
    id
    BG001
    title
    Safety Run-In: AZD9291 + Cisplatin + Pemetrexed
  3. description
    Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W
    id
    BG002
    title
    Randomized: AZD9291 + Chemo
  4. description
    Osimertinib (AZD9291) 80mg QD.
    id
    BG003
    title
    Randomized: AZD9291
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.82
          value
          62.4
        2. group Id
          BG001
          spread
          8.36
          value
          60.4
        3. group Id
          BG002
          spread
          10.03
          value
          61.0
        4. group Id
          BG003
          spread
          10.57
          value
          60.7
        5. group Id
          BG004
          spread
          10.3
          value
          60.9
      title
      Age (Years)
    description
    Age in Years at study entry
    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
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          44
        5. group Id
          BG004
          value
          88
        title
        <50
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          136
        4. group Id
          BG003
          value
          122
        5. group Id
          BG004
          value
          270
        title
        >=50-<65
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          82
        4. group Id
          BG003
          value
          88
        5. group Id
          BG004
          value
          179
        title
        >=65-<75
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          50
        title
        >=75
      title
      Age Group
    description
    Age Groups in Years at study entry
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          173
        4. group Id
          BG003
          value
          169
        5. group Id
          BG004
          value
          361
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          106
        4. group Id
          BG003
          value
          109
        5. group Id
          BG004
          value
          226
        title
        Male
      title
      Sex
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          68
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          239
        4. group Id
          BG003
          value
          248
        5. group Id
          BG004
          value
          517
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        title
        Unknown or Not Reported
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        title
        Black or African American
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or other Pacific Islander
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          17
        title
        American Indian or Alaska Native
      4. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          179
        4. group Id
          BG003
          value
          176
        5. group Id
          BG004
          value
          377
        title
        Asian
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          74
        4. group Id
          BG003
          value
          83
        5. group Id
          BG004
          value
          165
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          23
        title
        Other
      title
      Race
    description
    Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          108
        4. group Id
          BG003
          value
          107
        5. group Id
          BG004
          value
          231
        title
        Asian, not specified
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          71
        4. group Id
          BG003
          value
          69
        5. group Id
          BG004
          value
          146
        title
        Chinese
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          99
        4. group Id
          BG003
          value
          100
        5. group Id
          BG004
          value
          207
        title
        Other ethnic population (Non-Asian)
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        title
        Missing
      title
      Ethnic Population
    description
    Ethnic population
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Safety Run-In treatment arms are based on the Safety set, which includes all participants allocated to the safety run-in group of this study and who receive at least 1 dose of study treatment (Osimertinib, Cisplatin, Carboplatin, or Pemetrexed). The Randomized treatment arms are based on the Full Analysis set, which includes all participants allocated to the randomized group of this study and who were randomized to a treatment arm.

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Preserved source evidence · Not medical advice