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NCT04538664 · BASELINE

Baseline characteristics

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions · Source last updated 2026-08-31

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
      155
    2. group Id
      BG001
      value
      153
    3. group Id
      BG002
      value
      308
    units
    Participants
groups
  1. description
    Participants received chemotherapy with pemetrexed 500 milligrams per meter square (mg/m\^2) Intraveous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 (AUC 5) IV infusion administered on Day 1 for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an open-label extension (OLE) phase, and participants either continued to receive the chemotherapy or crossover to amivantamab in the OLE phase.
    id
    BG000
    title
    Arm B: Chemotherapy Alone
  2. description
    Participants received amivantamab 1400 milligrams (mg) (1750 mg if body weight is greater than or equal to (\>=) 80 kilograms \[kg\]) by IV infusion once weekly starting from Cycle 1 Day 1 up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 up to Cycle 5 Day 1. Participants received chemotherapy with pemetrexed 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 milligrams per milliliter (mg/mL) per minute (AUC 5) was administered as an IV infusion on Day 1, for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an OLE phase, and participants continued to receive amivantamab plus chemotherapy in the OLE phase.
    id
    BG001
    title
    Arm A: Amivantamab + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.01
          value
          60
        2. group Id
          BG001
          spread
          11.92
          value
          59.3
        3. group Id
          BG002
          spread
          11.95
          value
          59.6
    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
          93
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          178
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          130
        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
          9
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          22
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          145
        2. group Id
          BG001
          value
          137
        3. group Id
          BG002
          value
          282
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        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
          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
          89
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          186
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          109
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        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
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      AUSTRALIA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      BELGIUM
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
      title
      BRAZIL
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
      title
      CANADA
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          87
      title
      CHINA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      title
      FRANCE
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      GERMANY
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      HUNGARY
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
      title
      INDIA
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      ISRAEL
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
      title
      ITALY
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          34
      title
      JAPAN
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      155
    2. group Id
      BG001
      value
      153
    3. group Id
      BG002
      value
      308
    units
    Participants
groups
  1. description
    Participants received chemotherapy with pemetrexed 500 milligrams per meter square (mg/m\^2) Intraveous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 (AUC 5) IV infusion administered on Day 1 for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an open-label extension (OLE) phase, and participants either continued to receive the chemotherapy or crossover to amivantamab in the OLE phase.
    id
    BG000
    title
    Arm B: Chemotherapy Alone
  2. description
    Participants received amivantamab 1400 milligrams (mg) (1750 mg if body weight is greater than or equal to (\>=) 80 kilograms \[kg\]) by IV infusion once weekly starting from Cycle 1 Day 1 up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 up to Cycle 5 Day 1. Participants received chemotherapy with pemetrexed 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 milligrams per milliliter (mg/mL) per minute (AUC 5) was administered as an IV infusion on Day 1, for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an OLE phase, and participants continued to receive amivantamab plus chemotherapy in the OLE phase.
    id
    BG001
    title
    Arm A: Amivantamab + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.01
          value
          60
        2. group Id
          BG001
          spread
          11.92
          value
          59.3
        3. group Id
          BG002
          spread
          11.95
          value
          59.6
    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
          93
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          178
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          130
        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
          9
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          22
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          145
        2. group Id
          BG001
          value
          137
        3. group Id
          BG002
          value
          282
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        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
          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
          89
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          186
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          109
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        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
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      AUSTRALIA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      BELGIUM
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
      title
      BRAZIL
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
      title
      CANADA
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          87
      title
      CHINA
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
      title
      FRANCE
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      GERMANY
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      HUNGARY
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
      title
      INDIA
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      ISRAEL
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
      title
      ITALY
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          34
      title
      JAPAN
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice