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NCT05091567 · OUTCOME

Randomized Phase: Confirmed Objective Response Rate (ORR) as Determined by the IRF

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 complete response (CR) or partial response (PR) as determined by the IRF using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions or 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 sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Percentages have been rounded off.

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 IRF.

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
Atezolizumab182
Atezolizumab+ Lurbinectedin175

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Atezolizumab10.46.406.4015.82Not reported
Atezolizumab+ Lurbinectedin19.413.8513.8526.08Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.07
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    16.90
    group Description
    Stratified Analysis: The stratification factors were ECOGPS at randomization (0 vs. 1);LDH at randomization (\<=ULN vs \>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
    8.99
Complete source fields
analyses
  1. ci Lower Limit
    1.07
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    16.90
    group Description
    Stratified Analysis: The stratification factors were ECOGPS at randomization (0 vs. 1);LDH at randomization (\<=ULN vs \>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
    8.99
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.40
        spread
        6.40
        upper Limit
        15.82
        value
        10.4
      2. group Id
        OG001
        lower Limit
        13.85
        spread
        13.85
        upper Limit
        26.08
        value
        19.4
denoms
  1. counts
    1. group Id
      OG000
      value
      182
    2. group Id
      OG001
      value
      175
    units
    Participants
description
ORR was defined as the percentage of participants with an objective tumor response of complete response (CR) or partial response (PR) as determined by the IRF using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions or 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 sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Percentages have been rounded off.
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 IRF.
reporting Status
POSTED
time Frame
Up to 26 months
title
Randomized Phase: Confirmed Objective Response Rate (ORR) as Determined by the IRF
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice