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NCT04487080 · BASELINE

Baseline characteristics

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Source last updated 2026-08-28

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
      429
    2. group Id
      BG001
      value
      429
    3. group Id
      BG002
      value
      216
    4. group Id
      BG003
      value
      1074
    units
    Participants
groups
  1. description
    Participants received combination therapy of amivantamab 1050 milligrams (mg) for body weight (BW) less than (\<) 80 kilograms (kg) or 1400 mg for BW greater than or equal to (\>=) 80 kg intravenous (IV) infusion once weekly in 28-day treatment cycles: at Cycle 1 Days 1/2 (split dose, Day 1: 350 mg regardless of BW; Day 2: 700 mg or 1050 mg \[if BW \>=80 kg\]), 8, 15, and 22 and then once every 2 weeks (at Day 1 and 15) from Cycle 2 onwards; and lazertinib 240 mg (3 tablets of 80 mg) orally once daily. Participants continued treatment until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
    id
    BG000
    title
    Experimental: Arm A (Open-label): Amivantamab + Lazertinib
  2. description
    Participants received osimertinib 80 mg capsule orally once daily along with 3 tablets of matching placebo of lazertinib 240 mg tablets orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
    id
    BG001
    title
    Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib
  3. description
    Participants received lazertinib 240 mg (3 tablets of 80 mg) orally once daily along with single capsule of matching placebo of osimertinib 80 mg orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
    id
    BG002
    title
    Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.63
          value
          62.7
        2. group Id
          BG001
          spread
          11.52
          value
          61.9
        3. group Id
          BG002
          spread
          10.69
          value
          61.3
        4. group Id
          BG003
          spread
          11.01
          value
          62.1
    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
          275
        2. group Id
          BG001
          value
          251
        3. group Id
          BG002
          value
          136
        4. group Id
          BG003
          value
          662
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          80
        4. group Id
          BG003
          value
          412
        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
          56
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          125
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          371
        2. group Id
          BG001
          value
          382
        3. group Id
          BG002
          value
          190
        4. group Id
          BG003
          value
          943
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        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
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          18
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          251
        3. group Id
          BG002
          value
          128
        4. group Id
          BG003
          value
          629
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          164
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          408
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          25
      title
      ARGENTINA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          13
      title
      AUSTRALIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          7
      title
      BELGIUM
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          69
      title
      BRAZIL
    5. 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
          2
      title
      CANADA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          203
      title
      CHINA
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          29
      title
      FRANCE
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
      title
      GERMANY
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      HUNGARY
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          25
      title
      INDIA
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
      title
      ISRAEL
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          24
      title
      ITALY
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      429
    2. group Id
      BG001
      value
      429
    3. group Id
      BG002
      value
      216
    4. group Id
      BG003
      value
      1074
    units
    Participants
groups
  1. description
    Participants received combination therapy of amivantamab 1050 milligrams (mg) for body weight (BW) less than (\<) 80 kilograms (kg) or 1400 mg for BW greater than or equal to (\>=) 80 kg intravenous (IV) infusion once weekly in 28-day treatment cycles: at Cycle 1 Days 1/2 (split dose, Day 1: 350 mg regardless of BW; Day 2: 700 mg or 1050 mg \[if BW \>=80 kg\]), 8, 15, and 22 and then once every 2 weeks (at Day 1 and 15) from Cycle 2 onwards; and lazertinib 240 mg (3 tablets of 80 mg) orally once daily. Participants continued treatment until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
    id
    BG000
    title
    Experimental: Arm A (Open-label): Amivantamab + Lazertinib
  2. description
    Participants received osimertinib 80 mg capsule orally once daily along with 3 tablets of matching placebo of lazertinib 240 mg tablets orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
    id
    BG001
    title
    Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib
  3. description
    Participants received lazertinib 240 mg (3 tablets of 80 mg) orally once daily along with single capsule of matching placebo of osimertinib 80 mg orally once daily from Cycle 1 Day 1 until disease progression, participant consent withdrawal, adverse event, investigator's decision, or initiation of new systemic anti-cancer treatment.
    id
    BG002
    title
    Experimental: Arm C (Double-blind): Lazertinib+Placebo Matching Osimertinib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.63
          value
          62.7
        2. group Id
          BG001
          spread
          11.52
          value
          61.9
        3. group Id
          BG002
          spread
          10.69
          value
          61.3
        4. group Id
          BG003
          spread
          11.01
          value
          62.1
    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
          275
        2. group Id
          BG001
          value
          251
        3. group Id
          BG002
          value
          136
        4. group Id
          BG003
          value
          662
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          80
        4. group Id
          BG003
          value
          412
        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
          56
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          125
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          371
        2. group Id
          BG001
          value
          382
        3. group Id
          BG002
          value
          190
        4. group Id
          BG003
          value
          943
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        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
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          18
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          251
        3. group Id
          BG002
          value
          128
        4. group Id
          BG003
          value
          629
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          164
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          408
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          25
      title
      ARGENTINA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          13
      title
      AUSTRALIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          7
      title
      BELGIUM
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          69
      title
      BRAZIL
    5. 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
          2
      title
      CANADA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          203
      title
      CHINA
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          29
      title
      FRANCE
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
      title
      GERMANY
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      HUNGARY
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          25
      title
      INDIA
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
      title
      ISRAEL
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          24
      title
      ITALY
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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