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NCT03735121 · OUTCOME

Part 2: Duration of Response (DOR)

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Source last updated 2025-12-05

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
Up to approximately 25 months

What was measured

DOR was defined as the time from first occurrence of a documented confirmed objective response (CR or PR) to PD as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SODs must also demonstrate an absolute increase of ≥ 5 mm.

Analysis population: DOR-evaluable population included all participants with a measurable disease at baseline and a post-baseline confirmed objective response (CR or PR).

Groups in this outcome

Part 2: Atezolizumab IV 1200 mg

Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.

Part 2: Atezolizumab SC 1875 mg

Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Part 2: Atezolizumab IV 1200 mg13
Part 2: Atezolizumab SC 1875 mg27

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: Atezolizumab IV 1200 mg11.2Not reported4.2NAThe upper limit of the 95% confidence interval (CI) was not estimable due to an insufficient number of participants with events.
Part 2: Atezolizumab SC 1875 mg15.1Not reported5.6NAThe upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.

Source statistical analyses

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

  1. ci Lower Limit
    0.34
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.42
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8375
    param Type
    Hazard Ratio (HR)
    param Value
    0.90
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.34
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.42
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8375
    param Type
    Hazard Ratio (HR)
    param Value
    0.90
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the 95% confidence interval (CI) was not estimable due to an insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        4.2
        upper Limit
        NA
        value
        11.2
      2. comment
        The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        5.6
        upper Limit
        NA
        value
        15.1
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      27
    units
    Participants
description
DOR was defined as the time from first occurrence of a documented confirmed objective response (CR or PR) to PD as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SODs must also demonstrate an absolute increase of ≥ 5 mm.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
    id
    OG000
    title
    Part 2: Atezolizumab IV 1200 mg
  2. description
    Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
    id
    OG001
    title
    Part 2: Atezolizumab SC 1875 mg
param Type
MEDIAN
population Description
DOR-evaluable population included all participants with a measurable disease at baseline and a post-baseline confirmed objective response (CR or PR).
reporting Status
POSTED
time Frame
Up to approximately 25 months
title
Part 2: Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice