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NCT02763579 · OUTCOME

PFS Rate at 6 Months and at 1 Year in 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
95% Confidence Interval
Time frame
6 months, 1 year

What was measured

PFS rates at 6 months and at 1 year is defined as the proportion of participants who are alive without disease progression 6 months and 1 year 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

6 Months
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + Carboplatin + Etoposide22.39Not reported16.5628.22Not reported
Atezolizumab + Carboplatin + Etoposide30.86Not reported24.2637.45Not reported
1 Year
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + Carboplatin + Etoposide5.35Not reported2.148.56Not reported
Atezolizumab + Carboplatin + Etoposide12.62Not reported7.8517.40Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -0.33
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    17.27
    group Description
    PFS Rate at 6 months
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0593
    param Type
    Difference in Event Free Rate
    param Value
    8.47
    statistical Method
    Z-test
  2. ci Lower Limit
    1.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    13.02
    group Description
    PFS Rate at 1 year
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0133
    param Type
    Difference in Event Free Rate
    param Value
    7.27
    statistical Method
    Z-test
Complete source fields
analyses
  1. ci Lower Limit
    -0.33
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    17.27
    group Description
    PFS Rate at 6 months
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0593
    param Type
    Difference in Event Free Rate
    param Value
    8.47
    statistical Method
    Z-test
  2. ci Lower Limit
    1.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    13.02
    group Description
    PFS Rate at 1 year
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0133
    param Type
    Difference in Event Free Rate
    param Value
    7.27
    statistical Method
    Z-test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.56
        upper Limit
        28.22
        value
        22.39
      2. group Id
        OG001
        lower Limit
        24.26
        upper Limit
        37.45
        value
        30.86
    title
    6 Months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.14
        upper Limit
        8.56
        value
        5.35
      2. group Id
        OG001
        lower Limit
        7.85
        upper Limit
        17.40
        value
        12.62
    title
    1 Year
denoms
  1. counts
    1. group Id
      OG000
      value
      202
    2. group Id
      OG001
      value
      201
    units
    Participants
description
PFS rates at 6 months and at 1 year is defined as the proportion of participants who are alive without disease progression 6 months and 1 year after randomization, respectively.
dispersion Type
95% Confidence Interval
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
6 months, 1 year
title
PFS Rate at 6 Months and at 1 Year in Global Population
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice