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NCT02125461 · OUTCOME

Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1

A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer · Source last updated 2023-10-10

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.

What was measured

DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique.

Analysis population: FAS included all randomized patients, analyzed on an ITT basis. Only patients with an objective response were included in the analysis.

Groups in this outcome

Durvalumab (MEDI4736)

Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.

Placebo

Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.

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

Analysis denominator · Participants

GroupSource count
Durvalumab (MEDI4736)133
Placebo38

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durvalumab (MEDI4736)NANot reported27.4NAThe median and upper limit of 95% CI could not be calculated as they were not reached.
Placebo18.4Not reported6.724.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The median and upper limit of 95% CI could not be calculated as they were not reached.
        group Id
        OG000
        lower Limit
        27.4
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        6.7
        upper Limit
        24.5
        value
        18.4
denoms
  1. counts
    1. group Id
      OG000
      value
      133
    2. group Id
      OG001
      value
      38
    units
    Participants
description
DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
    id
    OG000
    title
    Durvalumab (MEDI4736)
  2. description
    Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
FAS included all randomized patients, analyzed on an ITT basis. Only patients with an objective response were included in the analysis.
reporting Status
POSTED
time Frame
Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
title
Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice