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NCT03164616 · BASELINE

Baseline characteristics

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). · Source last updated 2026-03-13

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
      338
    2. group Id
      BG001
      value
      338
    3. group Id
      BG002
      value
      337
    4. group Id
      BG003
      value
      1013
    units
    Participants
groups
  1. description
    During chemotherapy (combination) stage: Patients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy. Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
    id
    BG000
    title
    T + D + SoC
  2. description
    During chemotherapy (combination) stage: Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
    id
    BG001
    title
    D + SoC
  3. description
    During chemotherapy (combination) stage: Patients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up. The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator.
    id
    BG002
    title
    SoC Alone
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.43
          value
          62.6
        2. group Id
          BG001
          spread
          9.10
          value
          63.5
        3. group Id
          BG002
          spread
          9.87
          value
          63.1
        4. group Id
          BG003
          spread
          9.47
          value
          63.1
    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
          69
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          89
        4. group Id
          BG003
          value
          243
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          253
        3. group Id
          BG002
          value
          248
        4. group Id
          BG003
          value
          770
        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
          205
        2. group Id
          BG001
          value
          182
        3. group Id
          BG002
          value
          179
        4. group Id
          BG003
          value
          566
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          20
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          128
        4. group Id
          BG003
          value
          350
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          38
        title
        American Indian or Alaska Native
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          37
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          160
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          287
        2. group Id
          BG001
          value
          284
        3. group Id
          BG002
          value
          282
        4. group Id
          BG003
          value
          853
        title
        Not Hispanic or Latino
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          86
        title
        ≥18 to <50
      2. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          146
        4. group Id
          BG003
          value
          450
        title
        ≥50 to <65
      3. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          130
        3. group Id
          BG002
          value
          121
        4. group Id
          BG003
          value
          363
        title
        ≥65 to <75
      4. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          114
        title
        ≥75
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age Categorical
    unit Of Measure
    Participants
population Description
Global cohort: All patients in the full analysis set (FAS), which included all randomized patients, were included in the baseline analysis. Patients were included in the analysis in the treatment arm to which they were randomized, regardless of the treatment they received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      338
    2. group Id
      BG001
      value
      338
    3. group Id
      BG002
      value
      337
    4. group Id
      BG003
      value
      1013
    units
    Participants
groups
  1. description
    During chemotherapy (combination) stage: Patients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy. Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
    id
    BG000
    title
    T + D + SoC
  2. description
    During chemotherapy (combination) stage: Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
    id
    BG001
    title
    D + SoC
  3. description
    During chemotherapy (combination) stage: Patients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up. The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator.
    id
    BG002
    title
    SoC Alone
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.43
          value
          62.6
        2. group Id
          BG001
          spread
          9.10
          value
          63.5
        3. group Id
          BG002
          spread
          9.87
          value
          63.1
        4. group Id
          BG003
          spread
          9.47
          value
          63.1
    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
          69
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          89
        4. group Id
          BG003
          value
          243
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          253
        3. group Id
          BG002
          value
          248
        4. group Id
          BG003
          value
          770
        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
          205
        2. group Id
          BG001
          value
          182
        3. group Id
          BG002
          value
          179
        4. group Id
          BG003
          value
          566
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          20
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          128
        4. group Id
          BG003
          value
          350
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Native Hawaiian or other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          38
        title
        American Indian or Alaska Native
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          37
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          160
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          287
        2. group Id
          BG001
          value
          284
        3. group Id
          BG002
          value
          282
        4. group Id
          BG003
          value
          853
        title
        Not Hispanic or Latino
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          86
        title
        ≥18 to <50
      2. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          146
        4. group Id
          BG003
          value
          450
        title
        ≥50 to <65
      3. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          130
        3. group Id
          BG002
          value
          121
        4. group Id
          BG003
          value
          363
        title
        ≥65 to <75
      4. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          114
        title
        ≥75
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age Categorical
    unit Of Measure
    Participants
population Description
Global cohort: All patients in the full analysis set (FAS), which included all randomized patients, were included in the baseline analysis. Patients were included in the analysis in the treatment arm to which they were randomized, regardless of the treatment they received.

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Preserved source evidence · Not medical advice