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NCT02669914 · OUTCOME

Progression-free Survival (PFS)

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

* PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Unequivocal progression of existing non-target lesions.

Analysis population: There were not any participants enrolled in 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 Corticosteroids4
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 Corticosteroids51.5Not reported1864Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18
        upper Limit
        64
        value
        51.5
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
* PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Unequivocal progression of existing non-target lesions.
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
There were not any participants enrolled in 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
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice