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NCT02763579 · OUTCOME

Percentage of Participants With Anti-Drug Antibodies (ADA) to 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Predose (0 hours [H]) on Day (D) 1 of Cycles (C) 1, 2, 3, 4, 8, 16, and every 8 cycles (Q8C) thereafter (cycle = 21 days) until treatment discontinuation (up to 23 months) and 120 days after last dose (up to approximately 23 months overall)

What was measured

The baseline prevalence and post-baseline incidence of ADAs against atezolizumab.

Analysis population: ADA analyses were based on ADA observations from participants who had received atezolizumab treatment and were evaluated for immunogenicity.

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 + Etoposide198

Reported measurements

Baseline evaluable participants

Analysis denominator · Participants

GroupSource count
Atezolizumab + Carboplatin + Etoposide196
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab + Carboplatin + Etoposide2.0Not reportedNot reportedNot reportedNot reported
Post-baseline evaluable participants

Analysis denominator · Participants

GroupSource count
Atezolizumab + Carboplatin + Etoposide188
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab + Carboplatin + Etoposide18.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        196
      units
      Participants
    title
    Baseline evaluable participants
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        188
      units
      Participants
    title
    Post-baseline evaluable participants
denoms
  1. counts
    1. group Id
      OG000
      value
      198
    units
    Participants
description
The baseline prevalence and post-baseline incidence of ADAs against atezolizumab.
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
NUMBER
population Description
ADA analyses were based on ADA observations from participants who had received atezolizumab treatment and were evaluated for immunogenicity.
reporting Status
POSTED
time Frame
Predose (0 hours [H]) on Day (D) 1 of Cycles (C) 1, 2, 3, 4, 8, 16, and every 8 cycles (Q8C) thereafter (cycle = 21 days) until treatment discontinuation (up to 23 months) and 120 days after last dose (up to approximately 23 months overall)
title
Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab in the Global Population
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice