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NCT04914897 · FLOW

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A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202) · Source last updated 2025-10-02

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

groups
  1. description
    Participants with previously untreated Stage IV non-small cell lung cancer (NSCLC) and programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) of \>=50% were included in this cohort. Participants received pegenzileukin 24 microgram per kilogram (μg/kg) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion over 30 minutes every 3 weeks (q3w) on Day 1 of each cycle (each cycle is 21 days) (as first-line \[1L\] therapy), until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
    id
    FG000
    title
    Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
  2. description
    Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
    id
    FG001
    title
    Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
  3. description
    Participants with NSCLC for whom standard of care (SOC) was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as second-line or third-line \[2/3L\] therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
    id
    FG002
    title
    Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
  4. description
    Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
    id
    FG003
    title
    Cohort C1:Mesothelioma: Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Poor compliance to protocol
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        21
      type
      Progressive disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        6
      type
      Adverse event: Not related to Coronavirus Disease 2019 (COVID-19)
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        29
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        39
      4. group Id
        FG003
        num Subjects
        29
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study was terminated based on strategic sponsor decision not driven by any safety concerns. The Cohorts B2 and A3 were not initiated and no participants were enrolled. Note: Reason for not completed = Reason for permanent full intervention discontinuation.
recruitment Details
This study was conducted at 31 centers (corresponds to number of sites which screened at least one participant) in 11 countries. Out of 152 participants who were screened from 23 September 2021 to 07 October 2022, 106 participants were enrolled in the study and were assigned to 1 of the 4 cohorts (Cohorts A1, A2, B1, and C1) based on their disease type.
Complete source fields
groups
  1. description
    Participants with previously untreated Stage IV non-small cell lung cancer (NSCLC) and programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) of \>=50% were included in this cohort. Participants received pegenzileukin 24 microgram per kilogram (μg/kg) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion over 30 minutes every 3 weeks (q3w) on Day 1 of each cycle (each cycle is 21 days) (as first-line \[1L\] therapy), until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
    id
    FG000
    title
    Cohort A1:NSCLC, PD-L1 TPS >=50%:Pegenzileukin 24 μg/kg + Pembrolizumab as 1L Therapy
  2. description
    Participants with previously untreated Stage IV NSCLC and PD-L1 TPS of 1%-49% were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 1L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
    id
    FG001
    title
    Cohort A2:NSCLC, PD-L1 TPS 1%-49%:Pegenzileukin 24 μg/kg+Pembrolizumab as 1L Therapy
  3. description
    Participants with NSCLC for whom standard of care (SOC) was not in their best interest or where no SOC was established were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as second-line or third-line \[2/3L\] therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
    id
    FG002
    title
    Cohort B1: NSCLC:Pegenzileukin 24 μg/kg+Pembrolizumab as 2/3L Therapy
  4. description
    Participants with mesothelioma who had no SOC established and had experienced PD during or after at least one but no more than 2 prior regimens were included in this cohort. Participants received pegenzileukin 24 μg/kg along with pembrolizumab 200 mg via IV infusion over 30 minutes q3w on Day 1 of each cycle (each cycle is 21 days) (as 2/3L therapy), until PD, unacceptable AE or other full permanent discontinuation criteria was met or completion of Cycle 35.
    id
    FG003
    title
    Cohort C1:Mesothelioma: Pegenzileukin 24 μg /kg+Pembrolizumab as 2/3L Therapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Poor compliance to protocol
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        21
      type
      Progressive disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        6
      type
      Adverse event: Not related to Coronavirus Disease 2019 (COVID-19)
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        29
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        39
      4. group Id
        FG003
        num Subjects
        29
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study was terminated based on strategic sponsor decision not driven by any safety concerns. The Cohorts B2 and A3 were not initiated and no participants were enrolled. Note: Reason for not completed = Reason for permanent full intervention discontinuation.
recruitment Details
This study was conducted at 31 centers (corresponds to number of sites which screened at least one participant) in 11 countries. Out of 152 participants who were screened from 23 September 2021 to 07 October 2022, 106 participants were enrolled in the study and were assigned to 1 of the 4 cohorts (Cohorts A1, A2, B1, and C1) based on their disease type.

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Preserved source evidence · Not medical advice