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NCT05198934 · FLOW

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Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation · Source last updated 2026-07-22

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

groups
  1. description
    Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
    id
    FG000
    title
    Trifluridine and Tipiracil or Regorafenib
  2. description
    Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
    id
    FG001
    title
    Sotorasib 240 mg + Panitumumab
  3. description
    Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
    id
    FG002
    title
    Sotorasib 960 mg + Panitumumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        33
      type
      Participants continuing trial
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Withdrawal of consent from trial
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        18
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        53
      3. group Id
        FG002
        num Subjects
        53
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        53
      3. group Id
        FG002
        num Subjects
        53
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with previously treated metastatic colorectal cancer (CRC) with the kirsten rat sarcoma (KRAS) p.G12C mutation were enrolled and randomized 1:1:1 to receive either sotorasib 240 mg daily (QD) and panitumumab, sotorasib 960 mg QD and panitumumab, or investigator's choice (trifluridine and tipiracil, or regorafenib). Investigator's choice was declared prior to randomization.
recruitment Details
Participants were enrolled at 67 trial centers across Asia, Europe, North America, and Australia starting on 19 April 2022. The primary analysis results presented here, for primary analysis presented here are based on data cut-off (DCO) 19 June 2023. The trial is still ongoing.
Complete source fields
groups
  1. description
    Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
    id
    FG000
    title
    Trifluridine and Tipiracil or Regorafenib
  2. description
    Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
    id
    FG001
    title
    Sotorasib 240 mg + Panitumumab
  3. description
    Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
    id
    FG002
    title
    Sotorasib 960 mg + Panitumumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        33
      type
      Participants continuing trial
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      type
      Withdrawal of consent from trial
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        18
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        53
      3. group Id
        FG002
        num Subjects
        53
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        54
      2. group Id
        FG001
        num Subjects
        53
      3. group Id
        FG002
        num Subjects
        53
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with previously treated metastatic colorectal cancer (CRC) with the kirsten rat sarcoma (KRAS) p.G12C mutation were enrolled and randomized 1:1:1 to receive either sotorasib 240 mg daily (QD) and panitumumab, sotorasib 960 mg QD and panitumumab, or investigator's choice (trifluridine and tipiracil, or regorafenib). Investigator's choice was declared prior to randomization.
recruitment Details
Participants were enrolled at 67 trial centers across Asia, Europe, North America, and Australia starting on 19 April 2022. The primary analysis results presented here, for primary analysis presented here are based on data cut-off (DCO) 19 June 2023. The trial is still ongoing.

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Preserved source evidence · Independent clinical review pending · Not medical advice