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NCT03735121 · OUTCOME

Part 2: Progression-free Survival (PFS)

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

PFS was defined as the time from study start to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). 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 SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was analyzed using the Kaplan-Meier method.

Analysis population: FAS included all randomized participants, with participants grouped according to their assigned treatment.

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 mg124
Part 2: Atezolizumab SC 1875 mg247

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: Atezolizumab IV 1200 mg2.9Not reported1.84.2Not reported
Part 2: Atezolizumab SC 1875 mg2.8Not reported2.74.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.83
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.33
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6906
    param Type
    Odds Ratio (OR)
    param Value
    1.05
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.83
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.33
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6906
    param Type
    Odds Ratio (OR)
    param Value
    1.05
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        4.2
        value
        2.9
      2. group Id
        OG001
        lower Limit
        2.7
        upper Limit
        4.1
        value
        2.8
denoms
  1. counts
    1. group Id
      OG000
      value
      124
    2. group Id
      OG001
      value
      247
    units
    Participants
description
PFS was defined as the time from study start to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). 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 SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was analyzed using the Kaplan-Meier method.
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
FAS included all randomized participants, with participants grouped according to their assigned treatment.
reporting Status
POSTED
time Frame
Up to approximately 25 months
title
Part 2: Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice