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NCT05091567 · OUTCOME

Randomized Phase: Confirmed ORR as Determined by the Investigator

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer · Source last updated 2026-09-09

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
Up to 26 months

What was measured

ORR was defined as the percentage of participants with an objective tumor response of CR or PR as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.

Analysis population: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with measurable disease at baseline, as assessed by investigator.

Groups in this outcome

Atezolizumab

Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.

Atezolizumab+ Lurbinectedin

Participants received atezolizumab, 1200 mg, Q3W as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Atezolizumab205
Atezolizumab+ Lurbinectedin205

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Atezolizumab13.28.868.8618.58Not reported
Atezolizumab+ Lurbinectedin17.112.1912.1922.94Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -3.51
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.32
    group Description
    Stratified Analysis: The stratification factors were ECOGPS at randomization (0 vs. 1);LDH at randomization (\<=ULNvs \>ULN) via local laboratory test; Presence of liver metastases at enrollment (yes vs. no); Prior receipt of PCI (yes vs. no).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Difference in Overall Response Rates
    param Value
    3.90
Complete source fields
analyses
  1. ci Lower Limit
    -3.51
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.32
    group Description
    Stratified Analysis: The stratification factors were ECOGPS at randomization (0 vs. 1);LDH at randomization (\<=ULNvs \>ULN) via local laboratory test; Presence of liver metastases at enrollment (yes vs. no); Prior receipt of PCI (yes vs. no).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Difference in Overall Response Rates
    param Value
    3.90
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.86
        spread
        8.86
        upper Limit
        18.58
        value
        13.2
      2. group Id
        OG001
        lower Limit
        12.19
        spread
        12.19
        upper Limit
        22.94
        value
        17.1
denoms
  1. counts
    1. group Id
      OG000
      value
      205
    2. group Id
      OG001
      value
      205
    units
    Participants
description
ORR was defined as the percentage of participants with an objective tumor response of CR or PR as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
    id
    OG000
    title
    Atezolizumab
  2. description
    Participants received atezolizumab, 1200 mg, Q3W as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
    id
    OG001
    title
    Atezolizumab+ Lurbinectedin
param Type
NUMBER
population Description
FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with measurable disease at baseline, as assessed by investigator.
reporting Status
POSTED
time Frame
Up to 26 months
title
Randomized Phase: Confirmed ORR as Determined by the Investigator
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice