NCT02367781 · OUTCOME

Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-08-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: mcg/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days)

What was measured

Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.

Analysis population: The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples.

Groups in this outcome

Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)

Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

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
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)	465

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)	437

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)	392	114	Not reported	Not reported	Not reported

Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)	356

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)	454	170	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
114
value
392
denoms
counts
group Id
OG000
value
437
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
170
value
454
denoms
counts
group Id
OG000
value
356
units
Participants
title
Cycle 3 Day 1

denoms

counts
group Id
OG000
value
465
units
Participants

description

Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.

dispersion Type

Standard Deviation

groups

description
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
id
OG000
title
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)

param Type

MEAN

population Description

The PK-evaluable population was defined as all participants who received any dose of atezolizumab, carboplatin, or nab-paclitaxel and who had evaluable PK samples.

reporting Status

POSTED

time Frame

Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days)

title

Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm

type

SECONDARY

unit Of Measure

mcg/mL

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

Preserved source evidence · Not medical advice