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NCT03735121 · OUTCOME

Part 2: Objective Response Rate (ORR)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 25 months

What was measured

ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD in the absence of CR. Percentage of participants who achieved confirmed objective response (CR or PR) have been reported. Percentages have been rounded to one decimal place.

Analysis population: Response-evaluable population included all participants with measurable disease at baseline.

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 mg245

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: Atezolizumab IV 1200 mg10.5Not reported5.717.3Not reported
Part 2: Atezolizumab SC 1875 mg11.0Not reported7.415.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -6.56
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.63
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8757
    param Type
    Difference in ORR
    param Value
    0.54
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    -6.56
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.63
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8757
    param Type
    Difference in ORR
    param Value
    0.54
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.7
        upper Limit
        17.3
        value
        10.5
      2. group Id
        OG001
        lower Limit
        7.4
        upper Limit
        15.6
        value
        11.0
denoms
  1. counts
    1. group Id
      OG000
      value
      124
    2. group Id
      OG001
      value
      245
    units
    Participants
description
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD in the absence of CR. Percentage of participants who achieved confirmed objective response (CR or PR) have been reported. Percentages have been rounded to one decimal place.
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
NUMBER
population Description
Response-evaluable population included all participants with measurable disease at baseline.
reporting Status
POSTED
time Frame
Up to approximately 25 months
title
Part 2: Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice