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NCT02763579 · OUTCOME

Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population

A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC) · Source last updated 2023-07-28

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

Measure
MEAN
Unit
μg/mL
Interval / dispersion
Standard Deviation
Time frame
Predose on Day 1 of Cycles 1, 3, 4, 8, 16 and 24 (cycle length = 21 days)

What was measured

Atezolizumab pre-dose plasma concentration (Cmin) for each respective day.

Analysis population: PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.

Groups in this outcome

Atezolizumab + Carboplatin + Etoposide

Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Atezolizumab + Carboplatin + Etoposide194

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Carboplatin + Etoposide194
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Carboplatin + EtoposideNANANot reportedNot reportedBelow the level of detection.
Cycle 3 Day1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Carboplatin + Etoposide174
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Carboplatin + Etoposide80.632.1Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Carboplatin + Etoposide156
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Carboplatin + Etoposide13856.4Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Carboplatin + Etoposide88
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Carboplatin + Etoposide18673.5Not reportedNot reportedNot reported
Cycle 16 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Carboplatin + Etoposide22
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Carboplatin + Etoposide19663.1Not reportedNot reportedNot reported
Cycle 24 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Carboplatin + Etoposide4
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Carboplatin + Etoposide22143.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Below the level of detection.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        194
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.1
        value
        80.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        174
      units
      Participants
    title
    Cycle 3 Day1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        56.4
        value
        138
    denoms
    1. counts
      1. group Id
        OG000
        value
        156
      units
      Participants
    title
    Cycle 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        73.5
        value
        186
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      units
      Participants
    title
    Cycle 8 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        63.1
        value
        196
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Cycle 16 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        43.4
        value
        221
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 24 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      194
    units
    Participants
description
Atezolizumab pre-dose plasma concentration (Cmin) for each respective day.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
    id
    OG000
    title
    Atezolizumab + Carboplatin + Etoposide
param Type
MEAN
population Description
PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.
reporting Status
POSTED
time Frame
Predose on Day 1 of Cycles 1, 3, 4, 8, 16 and 24 (cycle length = 21 days)
title
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
type
SECONDARY
unit Of Measure
μg/mL

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

Preserved source evidence · Not medical advice