NCT03735121 · OUTCOME

Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1

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: GEOMETRIC_MEAN
Unit: micrograms day per mL (μg*day/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: From start of dosing up to Day 21 in Cycle 1 (Cycle length = 21 days)

Analysis population: PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis.

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

Group	Source count
Part 2: Atezolizumab IV 1200 mg	122
Part 2: Atezolizumab SC 1875 mg	246

Reported measurements

Source class 1

Values in micrograms day per mL (μg*day/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Atezolizumab IV 1200 mg	3327.9	19.4	Not reported	Not reported	Not reported
Part 2: Atezolizumab SC 1875 mg	2907.1	35.9	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
0.83
ci Num Sides
TWO_SIDED
ci Pct Value
90.0
ci Upper Limit
0.92
group Ids
OG000
OG001
non Inferiority Comment
The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% CI of the geometric mean ratio is ≥ the non-inferiority margin 0.8.
non Inferiority Type
NON_INFERIORITY
param Type
Geometric mean ratio
param Value
0.87

Complete source fields

analyses

ci Lower Limit
0.83
ci Num Sides
TWO_SIDED
ci Pct Value
90.0
ci Upper Limit
0.92
group Ids
OG000
OG001
non Inferiority Comment
The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% CI of the geometric mean ratio is ≥ the non-inferiority margin 0.8.
non Inferiority Type
NON_INFERIORITY
param Type
Geometric mean ratio
param Value
0.87

classes

categories
measurements
group Id
OG000
spread
19.4
value
3327.9
group Id
OG001
spread
35.9
value
2907.1

denoms

counts
group Id
OG000
value
122
group Id
OG001
value
246
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

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
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

GEOMETRIC_MEAN

population Description

PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis.

reporting Status

POSTED

time Frame

From start of dosing up to Day 21 in Cycle 1 (Cycle length = 21 days)

title

Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1

type

PRIMARY

unit Of Measure

micrograms day per mL (μg*day/mL)

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Preserved source evidence · Not medical advice