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NCT02888743 · OUTCOME

Overall Response Rate

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 2 years

What was measured

Determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. NSCLC: The proportion of patients with response (complete response or partial response according to RECIST) will be compared for each pair-wise comparison of radiotherapy (RT)-containing therapy and control using chi- squared tests. The difference between the proportions responding will be presented with a 90% confidence interval. CRC: The proportion of patients with response will be presented with a 90% exact confidence interval.

Analysis population: All patients receiving at least one regimen of protocol therapy.

Groups in this outcome

NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)

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

NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)

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

NSCLC Arm C (Tremelimumab, Durvalumab)

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

CRC Arm A (Tremelimumab, Durvalumab, HD-RT)

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

CRC Arm B (Tremelimumab, Durvalumab, LD-RT)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)26
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)26
NSCLC Arm C (Tremelimumab, Durvalumab)26
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)10
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)9

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)3Not reportedNot reportedNot reportedNot reported
NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)2Not reportedNot reportedNot reportedNot reported
NSCLC Arm C (Tremelimumab, Durvalumab)3Not reportedNot reportedNot reportedNot reported
CRC Arm A (Tremelimumab, Durvalumab, HD-RT)0Not reportedNot reportedNot reportedNot reported
CRC Arm B (Tremelimumab, Durvalumab, LD-RT)0Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -14.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    14.6
    estimate Comment
    Arm A compared with Arm C; normal approximation for confidence interval
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.99
    param Type
    Difference between proportions
    param Value
    0.0
    statistical Method
    Chi-squared
  2. ci Lower Limit
    -17.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    9.6
    estimate Comment
    Arm B compared with Arm C; normal approximation used for confidence interval.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.64
    param Type
    Difference between proportions
    param Value
    -3.8
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Lower Limit
    -14.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    14.6
    estimate Comment
    Arm A compared with Arm C; normal approximation for confidence interval
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.99
    param Type
    Difference between proportions
    param Value
    0.0
    statistical Method
    Chi-squared
  2. ci Lower Limit
    -17.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    9.6
    estimate Comment
    Arm B compared with Arm C; normal approximation used for confidence interval.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.64
    param Type
    Difference between proportions
    param Value
    -3.8
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      26
    3. group Id
      OG002
      value
      26
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      9
    units
    Participants
description
Determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. NSCLC: The proportion of patients with response (complete response or partial response according to RECIST) will be compared for each pair-wise comparison of radiotherapy (RT)-containing therapy and control using chi- squared tests. The difference between the proportions responding will be presented with a 90% confidence interval. CRC: The proportion of patients with response will be presented with a 90% exact confidence interval.
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
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    title
    CRC Arm A (Tremelimumab, Durvalumab, 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
    OG004
    title
    CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
param Type
COUNT_OF_PARTICIPANTS
population Description
All patients receiving at least one regimen of protocol therapy.
reporting Status
POSTED
time Frame
Up to 2 years
title
Overall Response Rate
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice