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NCT02367781 · OUTCOME

Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel

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 21, Cycle 2 Day 21, Cycle 3 Day 21, and Cycle 7 Day 21 (Cycle length = 21 days)

What was measured

Predose samples will be collected on the same day of treatment administration.

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

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

Reported measurements

Cycle 1 Day 21

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)416
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)70.935.1Not reportedNot reportedNot reported
Cycle 2 Day 21

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)384
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)11152.2Not reportedNot reportedNot reported
Cycle 3 Day 21

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)352
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)13457.8Not reportedNot reportedNot reported
Cycle 7 Day 21

Analysis denominator · Participants

GroupSource count
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)257
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)21893.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.1
        value
        70.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        416
      units
      Participants
    title
    Cycle 1 Day 21
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.2
        value
        111
    denoms
    1. counts
      1. group Id
        OG000
        value
        384
      units
      Participants
    title
    Cycle 2 Day 21
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.8
        value
        134
    denoms
    1. counts
      1. group Id
        OG000
        value
        352
      units
      Participants
    title
    Cycle 3 Day 21
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        93.7
        value
        218
    denoms
    1. counts
      1. group Id
        OG000
        value
        257
      units
      Participants
    title
    Cycle 7 Day 21
denoms
  1. counts
    1. group Id
      OG000
      value
      465
    units
    Participants
description
Predose samples will be collected on the same day of treatment administration.
dispersion Type
Standard Deviation
groups
  1. 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 21, Cycle 2 Day 21, Cycle 3 Day 21, and Cycle 7 Day 21 (Cycle length = 21 days)
title
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel
type
SECONDARY
unit Of Measure
mcg/mL

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

Preserved source evidence · Not medical advice