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NCT05091567 · OUTCOME

Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS)

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

PFS was defined as the time from randomization to the date of first documented PD as determined by the IRF according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death, whichever occurs first. 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 sum of diameters (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 millimetres (mm).

Analysis population: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.

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
Atezolizumab241
Atezolizumab+ Lurbinectedin242

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Atezolizumab2.141.641.642.73Not reported
Atezolizumab+ Lurbinectedin5.364.244.245.75Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.67
    group Description
    Stratified Analysis: The stratification factors were Eastern Cooperative Oncology Group performance status (ECOG PS) at randomization (0 vs. 1); Lactate Dehydrogenase (LDH) at randomization (\<=upper limit of normal (ULN) vs \>ULN) via local laboratory test; Presence of liver metastases at enrollment (yes vs. no); Prior receipt of prophylactic cranial irradiation (PCI) (yes vs. no).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < .0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.67
    group Description
    Stratified Analysis: The stratification factors were Eastern Cooperative Oncology Group performance status (ECOG PS) at randomization (0 vs. 1); Lactate Dehydrogenase (LDH) at randomization (\<=upper limit of normal (ULN) vs \>ULN) via local laboratory test; Presence of liver metastases at enrollment (yes vs. no); Prior receipt of prophylactic cranial irradiation (PCI) (yes vs. no).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < .0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.64
        spread
        1.64
        upper Limit
        2.73
        value
        2.14
      2. group Id
        OG001
        lower Limit
        4.24
        spread
        4.24
        upper Limit
        5.75
        value
        5.36
denoms
  1. counts
    1. group Id
      OG000
      value
      241
    2. group Id
      OG001
      value
      242
    units
    Participants
description
PFS was defined as the time from randomization to the date of first documented PD as determined by the IRF according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death, whichever occurs first. 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 sum of diameters (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 millimetres (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.
reporting Status
POSTED
time Frame
Up to 26 months
title
Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice