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NCT02763579 · OUTCOME

OS Rate at 1 Year and 2 Years 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
1 year, 2 years

What was measured

OS rates at 1 and 2 years is defined as the proportion of participants who are alive 1 year and 2 years after randomization, respectively.

Analysis population: The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.

Groups in this outcome

Placebo + Carboplatin + Etoposide

Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 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) placebo 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.

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
Placebo + Carboplatin + Etoposide202
Atezolizumab + Carboplatin + Etoposide201

Reported measurements

1 Year
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Carboplatin + Etoposide38.23Not reportedNot reportedNot reportedNot reported
Atezolizumab + Carboplatin + Etoposide51.69Not reportedNot reportedNot reportedNot reported
2 Years
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + Carboplatin + EtoposideNANot reportedNot reportedNot reportedInsufficient number of participants with events.
Atezolizumab + Carboplatin + EtoposideNANot reportedNot reportedNot reportedInsufficient number of participants with events.

Source statistical analyses

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

  1. ci Lower Limit
    3.29
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    23.64
    group Description
    OS Rate at 1 year
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0095
    param Type
    Difference in Event Free Rate
    param Value
    13.46
    statistical Method
    Z-test
Complete source fields
analyses
  1. ci Lower Limit
    3.29
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    23.64
    group Description
    OS Rate at 1 year
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0095
    param Type
    Difference in Event Free Rate
    param Value
    13.46
    statistical Method
    Z-test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        38.23
      2. group Id
        OG001
        value
        51.69
    title
    1 Year
  2. categories
    1. measurements
      1. comment
        Insufficient number of participants with events.
        group Id
        OG000
        value
        NA
      2. comment
        Insufficient number of participants with events.
        group Id
        OG001
        value
        NA
    title
    2 Years
denoms
  1. counts
    1. group Id
      OG000
      value
      202
    2. group Id
      OG001
      value
      201
    units
    Participants
description
OS rates at 1 and 2 years is defined as the proportion of participants who are alive 1 year and 2 years after randomization, respectively.
groups
  1. description
    Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 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) placebo 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
    Placebo + Carboplatin + Etoposide
  2. 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
    OG001
    title
    Atezolizumab + Carboplatin + Etoposide
param Type
NUMBER
population Description
The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
reporting Status
POSTED
time Frame
1 year, 2 years
title
OS Rate at 1 Year and 2 Years 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