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NCT03425643 · BASELINE

Baseline characteristics

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671) · Source last updated 2026-07-29

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
      397
    2. group Id
      BG001
      value
      400
    3. group Id
      BG002
      value
      797
    units
    Participants
groups
  1. description
    Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\].
    id
    BG000
    title
    NAC + Neoadjuvant/Adjuvant Pembrolizumab
  2. description
    Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\].
    id
    BG001
    title
    NAC + Neoadjuvant/Adjuvant Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.5
          value
          62.7
        2. group Id
          BG001
          spread
          8.1
          value
          63.6
        3. group Id
          BG002
          spread
          8.3
          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
          118
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          234
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          279
        2. group Id
          BG001
          value
          284
        3. group Id
          BG002
          value
          563
        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
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          70
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          333
        3. group Id
          BG002
          value
          662
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          65
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          249
        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
          6
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          489
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          13
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          29
        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
          171
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          344
        title
        Squamous
      2. measurements
        1. group Id
          BG000
          value
          226
        2. group Id
          BG001
          value
          227
        3. group Id
          BG002
          value
          453
        title
        Non-Squamous
    description
    Participants were classified according to tumor histology: Squamous or Non-squamous.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          239
        title
        Stage II
      2. measurements
        1. group Id
          BG000
          value
          279
        2. group Id
          BG001
          value
          279
        3. group Id
          BG002
          value
          558
        title
        Stage III
    description
    Participants were categorized by NSCLC stage: Stage II or Stage III. The lower the lung cancer stage, the less the cancer has spread. NSCLC stages can range from I to IV.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Overall Cancer Staging
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          134
        3. group Id
          BG002
          value
          266
        title
        TPS>=50%
      2. measurements
        1. group Id
          BG000
          value
          265
        2. group Id
          BG001
          value
          266
        3. group Id
          BG002
          value
          531
        title
        TPS<50%
    description
    Participants were assessed for their PD-L1 tumor expression status by immunohistochemistry assay using tumor tissue from an archival or newly obtained biopsy. Participants with a tumor proportion score (TPS) were classified as follows: ≥50% = PD-L1 strongly positive; 1-49% = PD-L1 weakly positive; and \<1% = PD-L1 negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Expression Level (50% cutoff)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          244
        title
        East-Asia
      2. measurements
        1. group Id
          BG000
          value
          274
        2. group Id
          BG001
          value
          279
        3. group Id
          BG002
          value
          553
        title
        Non-East Asia
    description
    Participants were categorized according to geographic region of site: Non-East Asia and East Asia.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      397
    2. group Id
      BG001
      value
      400
    3. group Id
      BG002
      value
      797
    units
    Participants
groups
  1. description
    Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\].
    id
    BG000
    title
    NAC + Neoadjuvant/Adjuvant Pembrolizumab
  2. description
    Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\].
    id
    BG001
    title
    NAC + Neoadjuvant/Adjuvant Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.5
          value
          62.7
        2. group Id
          BG001
          spread
          8.1
          value
          63.6
        3. group Id
          BG002
          spread
          8.3
          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
          118
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          234
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          279
        2. group Id
          BG001
          value
          284
        3. group Id
          BG002
          value
          563
        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
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          70
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          333
        3. group Id
          BG002
          value
          662
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          65
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          249
        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
          6
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          489
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          13
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          29
        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
          171
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          344
        title
        Squamous
      2. measurements
        1. group Id
          BG000
          value
          226
        2. group Id
          BG001
          value
          227
        3. group Id
          BG002
          value
          453
        title
        Non-Squamous
    description
    Participants were classified according to tumor histology: Squamous or Non-squamous.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          239
        title
        Stage II
      2. measurements
        1. group Id
          BG000
          value
          279
        2. group Id
          BG001
          value
          279
        3. group Id
          BG002
          value
          558
        title
        Stage III
    description
    Participants were categorized by NSCLC stage: Stage II or Stage III. The lower the lung cancer stage, the less the cancer has spread. NSCLC stages can range from I to IV.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Overall Cancer Staging
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          134
        3. group Id
          BG002
          value
          266
        title
        TPS>=50%
      2. measurements
        1. group Id
          BG000
          value
          265
        2. group Id
          BG001
          value
          266
        3. group Id
          BG002
          value
          531
        title
        TPS<50%
    description
    Participants were assessed for their PD-L1 tumor expression status by immunohistochemistry assay using tumor tissue from an archival or newly obtained biopsy. Participants with a tumor proportion score (TPS) were classified as follows: ≥50% = PD-L1 strongly positive; 1-49% = PD-L1 weakly positive; and \<1% = PD-L1 negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Expression Level (50% cutoff)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          244
        title
        East-Asia
      2. measurements
        1. group Id
          BG000
          value
          274
        2. group Id
          BG001
          value
          279
        3. group Id
          BG002
          value
          553
        title
        Non-East Asia
    description
    Participants were categorized according to geographic region of site: Non-East Asia and East Asia.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice