Skip to content
Triangle logo TriangleGet started
← Small Cell Lung Cancer

NCT05091567 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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).

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

→

primary · POSTED

OS was defined as the time from randomization to the date of death from any cause.

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

→

secondary · POSTED

PFS was defined as the time from randomization to the date of first documented PD as assessed by investigator according to 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 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.

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

→

secondary · POSTED

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.

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.

→

secondary · POSTED

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.

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.

→

secondary · POSTED

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.

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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Randomized Phase: Time to Confirmed Deterioration (TTCD) in Physical Functioning (PF) and Global Health Status (GHS) as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQC30)

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT05091567
qol key
qol-0012
source section id
NCT05091567-om-0012
source outcome index
12
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Randomized Phase: Time to Confirmed Deterioration (TTCD) in Physical Functioning (PF) and Global Health Status (GHS) as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQC30)
measure definition
EORTC QLQ-C30=30 questions assessing 5 aspects of participant functioning(physical,emotional,role,cognitive \&social),3 symptom scales,GHS/QoL \& 6 single items.PF scale=5 questions about participants PF \& daily activities(strenuous activities,long walks,short walks,bed/chair rest \& needing help with eating,dressing,washing themselves/using the toilet).PF scale scored on 4-point scale(1=Not at All-4=Very Much).GHS/QoL scored on 7-point scale(1=Very Poor- 7=Excellent).Scores were linearly transformed to a range of 0-100,higher scores=higher response level \& better QoL.TTCD for PF \& GHS/QoL=time from the date of randomization until first confirmed clinically meaningful deterioration,which is decrease from baseline in PF/GHS score that must be held for at least 2 consecutive assessments/initial decrease above baseline followed by death attributable to cancer progression within 6 weeks of the last deteriorated assessment.Score change≥10-point change in subscale score,considered meaningful.
time frame
Up to 26 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores=higher response level \& better
population note
FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT05091567
trial label
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
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0000
    source section id
    NCT05091567-om-0000
    source outcome index
    0
    endpoint
    Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS)
    endpoint definition
    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).
    time origin
    Up to 26 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0001
    source section id
    NCT05091567-om-0001
    source outcome index
    1
    endpoint
    Randomized Phase: Overall Survival (OS)
    endpoint definition
    OS was defined as the time from randomization to the date of death from any cause.
    time origin
    Up to 26 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0002
    source section id
    NCT05091567-om-0002
    source outcome index
    2
    endpoint
    Randomized Phase: Investigator-assessed PFS
    endpoint definition
    PFS was defined as the time from randomization to the date of first documented PD as assessed by investigator according to 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 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.
    time origin
    Up to 26 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0003
    source section id
    NCT05091567-om-0003
    source outcome index
    3
    endpoint
    Randomized Phase: Confirmed Objective Response Rate (ORR) as Determined by the IRF
    endpoint definition
    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.
    time origin
    Up to 26 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0004
    source section id
    NCT05091567-om-0004
    source outcome index
    4
    endpoint
    Randomized Phase: Confirmed ORR as Determined by the Investigator
    endpoint definition
    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.
    time origin
    Up to 26 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0005
    source section id
    NCT05091567-om-0005
    source outcome index
    5
    endpoint
    Randomized Phase: Duration of Response (DOR) as Determined by the IRF
    endpoint definition
    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.
    time origin
    Up to 26 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Atezolizumab
    regimen
    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.
    analyzed count
    241
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Atezolizumab+ Lurbinectedin
    regimen
    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.
    analyzed count
    242
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Atezolizumab
    regimen
    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.
    analyzed count
    241
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Atezolizumab+ Lurbinectedin
    regimen
    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.
    analyzed count
    242
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Atezolizumab
    regimen
    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.
    analyzed count
    241
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Atezolizumab+ Lurbinectedin
    regimen
    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.
    analyzed count
    242
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Atezolizumab
    regimen
    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.
    analyzed count
    182
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Atezolizumab+ Lurbinectedin
    regimen
    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.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Atezolizumab
    regimen
    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.
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Atezolizumab+ Lurbinectedin
    regimen
    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.
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Atezolizumab
    regimen
    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.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Atezolizumab+ Lurbinectedin
    regimen
    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.
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05091567-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    harm key
    EG000
    source section id
    NCT05091567-ae
    event group key
    EG000
    event group label
    Atezolizumab + Carboplatin + Etoposide
    serious affected
    181
    serious at risk
    653
    other affected
    526
    other at risk
    653
    frequency threshold
    5
    collection period
    Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
    event definition
    All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    harm key
    EG001
    source section id
    NCT05091567-ae
    event group key
    EG001
    event group label
    Atezolizumab
    serious affected
    41
    serious at risk
    240
    other affected
    127
    other at risk
    240
    frequency threshold
    5
    collection period
    Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
    event definition
    All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    harm key
    EG002
    source section id
    NCT05091567-ae
    event group key
    EG002
    event group label
    Atezolizumab+ Lurbinectedin
    serious affected
    75
    serious at risk
    242
    other affected
    213
    other at risk
    242
    frequency threshold
    5
    collection period
    Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
    event definition
    All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT05091567
    qol key
    qol-0012
    source section id
    NCT05091567-om-0012
    source outcome index
    12
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Randomized Phase: Time to Confirmed Deterioration (TTCD) in Physical Functioning (PF) and Global Health Status (GHS) as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQC30)
    measure definition
    EORTC QLQ-C30=30 questions assessing 5 aspects of participant functioning(physical,emotional,role,cognitive \&social),3 symptom scales,GHS/QoL \& 6 single items.PF scale=5 questions about participants PF \& daily activities(strenuous activities,long walks,short walks,bed/chair rest \& needing help with eating,dressing,washing themselves/using the toilet).PF scale scored on 4-point scale(1=Not at All-4=Very Much).GHS/QoL scored on 7-point scale(1=Very Poor- 7=Excellent).Scores were linearly transformed to a range of 0-100,higher scores=higher response level \& better QoL.TTCD for PF \& GHS/QoL=time from the date of randomization until first confirmed clinically meaningful deterioration,which is decrease from baseline in PF/GHS score that must be held for at least 2 consecutive assessments/initial decrease above baseline followed by death attributable to cancer progression within 6 weeks of the last deteriorated assessment.Score change≥10-point change in subscale score,considered meaningful.
    time frame
    Up to 26 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores=higher response level \& better
    population note
    FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice