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NCT05091567 · OUTCOME

Randomized Phase: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 26 months

What was measured

An AE =any unfavorable \& unintended sign (including abnormal laboratory values/abnormal clinical test results), symptoms/disease temporally associated with the use of a pharmaceutical product, whether considered related to the pharmaceutical product. SAE=any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. AESI= drug induced liver injury, suspected transmission of infectious agent via study treatment, hepatitis, systemic lupus erythematosus, hypersensitivity, etc. AESIs may include events not specified in the protocol.

Analysis population: Saftey analysis set (SAS)=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.

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
Atezolizumab240
Atezolizumab+ Lurbinectedin242

Reported measurements

AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab194Not reportedNot reportedNot reportedNot reported
Atezolizumab+ Lurbinectedin235Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab41Not reportedNot reportedNot reportedNot reported
Atezolizumab+ Lurbinectedin75Not reportedNot reportedNot reportedNot reported
AESIs for Atezolizumab
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab54Not reportedNot reportedNot reportedNot reported
Atezolizumab+ Lurbinectedin76Not reportedNot reportedNot reportedNot reported
AESIs for Lurbinectedin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab62Not reportedNot reportedNot reportedNot reported
Atezolizumab+ Lurbinectedin93Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        194
      2. group Id
        OG001
        value
        235
    title
    AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        75
    title
    SAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        76
    title
    AESIs for Atezolizumab
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        93
    title
    AESIs for Lurbinectedin
denoms
  1. counts
    1. group Id
      OG000
      value
      240
    2. group Id
      OG001
      value
      242
    units
    Participants
description
An AE =any unfavorable \& unintended sign (including abnormal laboratory values/abnormal clinical test results), symptoms/disease temporally associated with the use of a pharmaceutical product, whether considered related to the pharmaceutical product. SAE=any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. AESI= drug induced liver injury, suspected transmission of infectious agent via study treatment, hepatitis, systemic lupus erythematosus, hypersensitivity, etc. AESIs may include events not specified in the protocol.
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
COUNT_OF_PARTICIPANTS
population Description
Saftey analysis set (SAS)=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
reporting Status
POSTED
time Frame
Up to 26 months
title
Randomized Phase: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice