Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02775435 · BASELINE

Baseline characteristics

A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407) · Source last updated 2024-10-08

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
      278
    2. group Id
      BG001
      value
      281
    3. group Id
      BG002
      value
      559
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).
    id
    BG000
    title
    Pembrolizumab + Chemotherapy Combo
  2. description
    Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).
    id
    BG001
    title
    Placebo + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.8
          value
          65.0
        2. group Id
          BG001
          spread
          8.7
          value
          64.8
        3. group Id
          BG002
          spread
          8.7
          value
          64.9
    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
          58
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          104
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          220
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          455
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          108
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          216
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          430
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          11
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          194
        title
        TPS <1%
      2. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          353
        title
        TPS ≥1%
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        title
        Unknown
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Participants with a TPS ≥1% were classified as PD-L1 positive and participants with a TPS \<1% were classified as not PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          336
        title
        +Paclitaxel
      2. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          223
        title
        +Nab-paclitaxel
    description
    Participants were classified according to their taxane chemotherapy regimen: paclitaxel or nab-paclitaxel.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Taxane Chemotherapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          106
        title
        East Asia
      2. measurements
        1. group Id
          BG000
          value
          224
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          453
        title
        Non-East Asia
    description
    Participants were classified according to their geographic region: East Asia vs. non-East Asia.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      278
    2. group Id
      BG001
      value
      281
    3. group Id
      BG002
      value
      559
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants who received pembrolizumab 200 mg IV Day 1 of 21-day cycle for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab 200 mg IV Day 1 of 21-day cycle, at the investigator's discretion, for 17 cycles (\~ 1 year additional).
    id
    BG000
    title
    Pembrolizumab + Chemotherapy Combo
  2. description
    Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles. Participants with documented disease progression following placebo chemotherapy combo could switch-over to receive pembrolizumab for up to 35 cycles (\~ 2 years). Eligible cross over participants who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (\~ 1 year additional).
    id
    BG001
    title
    Placebo + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.8
          value
          65.0
        2. group Id
          BG001
          spread
          8.7
          value
          64.8
        3. group Id
          BG002
          spread
          8.7
          value
          64.9
    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
          58
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          104
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          220
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          455
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          108
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          216
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          430
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          11
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          194
        title
        TPS <1%
      2. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          353
        title
        TPS ≥1%
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        title
        Unknown
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Participants with a TPS ≥1% were classified as PD-L1 positive and participants with a TPS \<1% were classified as not PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          167
        3. group Id
          BG002
          value
          336
        title
        +Paclitaxel
      2. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          223
        title
        +Nab-paclitaxel
    description
    Participants were classified according to their taxane chemotherapy regimen: paclitaxel or nab-paclitaxel.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Taxane Chemotherapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          106
        title
        East Asia
      2. measurements
        1. group Id
          BG000
          value
          224
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          453
        title
        Non-East Asia
    description
    Participants were classified according to their geographic region: East Asia vs. non-East Asia.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice