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NCT03703297 · BASELINE

Baseline characteristics

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy · Source last updated 2025-11-21

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
      264
    2. group Id
      BG001
      value
      200
    3. group Id
      BG002
      value
      266
    4. group Id
      BG003
      value
      730
    units
    Participants
groups
  1. description
    Participants received durvalumab monotherapy (1500 mg for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    id
    BG000
    title
    Durvalumab
  2. description
    Participants received durvalumab in combination with tremelimumab (1500 mg durvalumab in combination with 75 mg tremelimumab for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg durvalumab in combination with 1 mg/kg tremelimumab for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    id
    BG001
    title
    Durvalumab Plus Tremelimumab
  3. description
    Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    id
    BG002
    title
    Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          160
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          162
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        <65 years
      2. measurements
        1. group Id
          BG000
          value
          104
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          104
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          78
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          178
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          188
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        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
          130
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          137
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          3
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          131
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          121
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          2
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          5
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        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
          8
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          14
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          255
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          249
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          3
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The full analysis set (FAS) included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      264
    2. group Id
      BG001
      value
      200
    3. group Id
      BG002
      value
      266
    4. group Id
      BG003
      value
      730
    units
    Participants
groups
  1. description
    Participants received durvalumab monotherapy (1500 mg for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    id
    BG000
    title
    Durvalumab
  2. description
    Participants received durvalumab in combination with tremelimumab (1500 mg durvalumab in combination with 75 mg tremelimumab for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg durvalumab in combination with 1 mg/kg tremelimumab for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    id
    BG001
    title
    Durvalumab Plus Tremelimumab
  3. description
    Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    id
    BG002
    title
    Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          160
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          162
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        <65 years
      2. measurements
        1. group Id
          BG000
          value
          104
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          104
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          78
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          178
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          188
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        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
          130
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          137
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          3
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          131
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          121
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          2
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          5
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        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
          8
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          14
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          255
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          249
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. comment
          Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
          group Id
          BG001
          value
          NA
        3. group Id
          BG002
          value
          3
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The full analysis set (FAS) included all randomized participants.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice