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NCT05091567 · OUTCOME

Randomized Phase: Duration of Response (DOR) 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 26 months

What was measured

DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR= time from first occurrence of a documented OR until the time of documented PD as determined by IRF assessment using RECIST v1.1 or death from any cause, whichever occurs first. CR=disappearance of all target and non-target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR= at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

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 response, per 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
Atezolizumab19
Atezolizumab+ Lurbinectedin34

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Atezolizumab5.62Not reported4.17NAUpper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
Atezolizumab+ Lurbinectedin9.00Not reported5.52NAUpper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        4.17
        upper Limit
        NA
        value
        5.62
      2. comment
        Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        5.52
        upper Limit
        NA
        value
        9.00
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      34
    units
    Participants
description
DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR= time from first occurrence of a documented OR until the time of documented PD as determined by IRF assessment using RECIST v1.1 or death from any cause, whichever occurs first. CR=disappearance of all target and non-target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR= at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
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
MEDIAN
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 response, per IRF.
reporting Status
POSTED
time Frame
Up to 26 months
title
Randomized Phase: Duration of Response (DOR) as Determined by the IRF
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice