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NCT02486718 · FLOW

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Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010] · Source last updated 2026-07-29

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

groups
  1. description
    All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.
    id
    FG000
    title
    Enrollment Phase
  2. description
    Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
    id
    FG001
    title
    Atezolizumab
  3. description
    Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
    id
    FG002
    title
    Best Supportive Care (BSC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Symptomatic deterioration
    3. reasons
      1. group Id
        FG000
        num Subjects
        86
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Reason not provided
    7. reasons
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease relapse
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    9. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1280
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1269
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Enrolled Safety-evaluable population included all eligible participants who were enrolled in the enrollment phase and who received at least one dose of chemotherapy (cisplatin, vinorelbine, docetaxel, gemcitabine, or pemetrexed), regardless of whether they are subsequently randomized or not.
      type
      Enrolled Safety-evaluable Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        1005
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        275
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Enrollment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        44
      3. group Id
        FG002
        num Subjects
        47
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        11
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Relapse
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        154
      3. group Id
        FG002
        num Subjects
        155
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        301
      3. group Id
        FG002
        num Subjects
        282
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        NOTE: 507 eligible participants were randomized to receive atezolizumab in the randomization phase.
        group Id
        FG001
        num Subjects
        507
      3. comment
        NOTE: 498 eligible participants were randomized to receive BSC in the randomization phase.
        group Id
        FG002
        num Subjects
        498
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        495
      3. group Id
        FG002
        num Subjects
        495
      comment
      Randomized safety population included all randomized participants who received at least one dose of the study treatment and all randomized participants who were randomized to the control arm and did not receive any dose of atezolizumab but who had at least one post-baseline safety assessment.
      type
      Randomized Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        507
      3. group Id
        FG002
        num Subjects
        498
      type
      NOT COMPLETED
    title
    Randomized Phase
pre Assignment Details
The study consists of 2 phases, an enrollment phase in which participants received up to 4 cycles of adjuvant cisplatin-based chemotherapy followed by randomized phase in which eligible participants were randomized to receive atezolizumab or best supportive care (BSC) i.e.no treatment.
recruitment Details
A total of 1280 participants with resectable Stage IB-IIIA non-small cell lung cancer (NSCLC) were enrolled in this study. Participants took part in the study at 227 investigative sites across 22 countries. The study is still ongoing.
Complete source fields
groups
  1. description
    All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.
    id
    FG000
    title
    Enrollment Phase
  2. description
    Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
    id
    FG001
    title
    Atezolizumab
  3. description
    Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
    id
    FG002
    title
    Best Supportive Care (BSC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Symptomatic deterioration
    3. reasons
      1. group Id
        FG000
        num Subjects
        86
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Reason not provided
    7. reasons
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease relapse
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    9. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1280
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1269
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Enrolled Safety-evaluable population included all eligible participants who were enrolled in the enrollment phase and who received at least one dose of chemotherapy (cisplatin, vinorelbine, docetaxel, gemcitabine, or pemetrexed), regardless of whether they are subsequently randomized or not.
      type
      Enrolled Safety-evaluable Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        1005
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        275
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Enrollment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        44
      3. group Id
        FG002
        num Subjects
        47
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        11
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Relapse
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        154
      3. group Id
        FG002
        num Subjects
        155
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        301
      3. group Id
        FG002
        num Subjects
        282
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        NOTE: 507 eligible participants were randomized to receive atezolizumab in the randomization phase.
        group Id
        FG001
        num Subjects
        507
      3. comment
        NOTE: 498 eligible participants were randomized to receive BSC in the randomization phase.
        group Id
        FG002
        num Subjects
        498
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        495
      3. group Id
        FG002
        num Subjects
        495
      comment
      Randomized safety population included all randomized participants who received at least one dose of the study treatment and all randomized participants who were randomized to the control arm and did not receive any dose of atezolizumab but who had at least one post-baseline safety assessment.
      type
      Randomized Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        507
      3. group Id
        FG002
        num Subjects
        498
      type
      NOT COMPLETED
    title
    Randomized Phase
pre Assignment Details
The study consists of 2 phases, an enrollment phase in which participants received up to 4 cycles of adjuvant cisplatin-based chemotherapy followed by randomized phase in which eligible participants were randomized to receive atezolizumab or best supportive care (BSC) i.e.no treatment.
recruitment Details
A total of 1280 participants with resectable Stage IB-IIIA non-small cell lung cancer (NSCLC) were enrolled in this study. Participants took part in the study at 227 investigative sites across 22 countries. The study is still ongoing.

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