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NCT02888743 · FLOW

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Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer · Source last updated 2026-07-31

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

groups
  1. description
    Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    FG000
    title
    NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
  2. description
    Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    FG001
    title
    NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
  3. description
    Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
    id
    FG002
    title
    NSCLC Arm C (Tremelimumab, Durvalumab)
  4. description
    Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    FG003
    title
    CRC Arm A (Tremelimumab, Druvalumab, HD-RT)
  5. description
    Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    FG004
    title
    CRC Arm B (Tremelimumab, Dervalumab, LD-RT)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Disease progression before treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Patient ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        9
      type
      Received Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        9
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
NSCLC: Ninety participants were randomized (30 per arm). A total of twelve participants either withdrew consent (N=5) before starting protocol therapy, were found to be ineligible (N=4), or progressed prior to starting protocol therapy (N=3) and were not included in the analysis. CRC: Twenty patients were randomized (10 per arm). One patient (Arm B) never started protocol therapy.
recruitment Details
Participants were recruited from 18 medical centers. The first participant was enrolled in August 2017 and the last in March 2019.
Complete source fields
groups
  1. description
    Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    FG000
    title
    NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
  2. description
    Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    FG001
    title
    NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
  3. description
    Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
    id
    FG002
    title
    NSCLC Arm C (Tremelimumab, Durvalumab)
  4. description
    Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    FG003
    title
    CRC Arm A (Tremelimumab, Druvalumab, HD-RT)
  5. description
    Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
    id
    FG004
    title
    CRC Arm B (Tremelimumab, Dervalumab, LD-RT)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Disease progression before treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Patient ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        9
      type
      Received Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        26
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        9
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
NSCLC: Ninety participants were randomized (30 per arm). A total of twelve participants either withdrew consent (N=5) before starting protocol therapy, were found to be ineligible (N=4), or progressed prior to starting protocol therapy (N=3) and were not included in the analysis. CRC: Twenty patients were randomized (10 per arm). One patient (Arm B) never started protocol therapy.
recruitment Details
Participants were recruited from 18 medical centers. The first participant was enrolled in August 2017 and the last in March 2019.

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Preserved source evidence · Not medical advice