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NCT02669914 · OUTCOME

Overall Survival (OS)

MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors · Source last updated 2018-11-06

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Up to 2 years after completion of treatment (estimated to be 2 years and 6 months)

What was measured

-Defined as the interval from the start of study therapy to death from any cause

Analysis population: One participant in Cohort A was lost to follow-up and is not evaluable for this outcome measure. There were not any participants enrolled to Cohort B or Cohort C.

Groups in this outcome

Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids

-MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.

Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids

-MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.

Cohort C: NSCLC or Non-NSCLC w/Corticosteroids

-MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.

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

Analysis denominator · Participants

GroupSource count
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids3
Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids0
Cohort C: NSCLC or Non-NSCLC w/Corticosteroids0

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids197Not reported130262Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        130
        upper Limit
        262
        value
        197
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
-Defined as the interval from the start of study therapy to death from any cause
dispersion Type
Full Range
groups
  1. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    OG000
    title
    Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids
  2. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    OG001
    title
    Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids
  3. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    OG002
    title
    Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
param Type
MEDIAN
population Description
One participant in Cohort A was lost to follow-up and is not evaluable for this outcome measure. There were not any participants enrolled to Cohort B or Cohort C.
reporting Status
POSTED
time Frame
Up to 2 years after completion of treatment (estimated to be 2 years and 6 months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice