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NCT02142738 · FLOW

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Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024) · Source last updated 2022-06-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.
    id
    FG000
    title
    Pembrolizumab
  2. description
    Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then 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 (approximately 1 additional year).
    id
    FG001
    title
    SOC Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        9
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        112
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        20
      type
      Follow up ended by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        151
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        150
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        83
      type
      Chemotherapy Switch to Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        1
      type
      Second Course Pembrolizumab
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        151
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Per protocol, it was planned that participants would be randomized 1:1 to receive either pembrolizumab or investigator-choice standard of care (SOC) chemotherapy and data analysis would be conducted on the two treatment arms: Pembrolizumab and SOC Chemotherapy.
Complete source fields
groups
  1. description
    Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.
    id
    FG000
    title
    Pembrolizumab
  2. description
    Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then 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 (approximately 1 additional year).
    id
    FG001
    title
    SOC Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        9
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        112
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        20
      type
      Follow up ended by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        151
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        150
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        83
      type
      Chemotherapy Switch to Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        1
      type
      Second Course Pembrolizumab
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        154
      2. group Id
        FG001
        num Subjects
        151
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Per protocol, it was planned that participants would be randomized 1:1 to receive either pembrolizumab or investigator-choice standard of care (SOC) chemotherapy and data analysis would be conducted on the two treatment arms: Pembrolizumab and SOC Chemotherapy.

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Preserved source evidence · Not medical advice