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← Small Cell Lung Cancer

NCT03703297 · STUDY IN CONTEXT

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

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. 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 per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of objective disease progression (PD) or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.

The FAS included all randomized participants.

→

primary · POSTED

OS was defined as the time from the date of randomization until death due to any cause. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.

The FAS included all randomized participants.

→

secondary · NOT_POSTED

PFS per RECIST 1.1 assessed by BICR is defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to progression. PD is defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir.

Source null

→

secondary · NOT_POSTED

OS is defined as the time from the date of randomization until death due to any cause.

Source null

→

secondary · POSTED

ORR per RECIST 1.1 assessed by BICR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) (i.e., unconfirmed response). CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.

The FAS included all randomized participants. Only participants with measurable disease at baseline per BICR are reported.

→

secondary · NOT_POSTED

ORR per RECIST 1.1 assessed by BICR is defined as the percentage of participants with at least 1 visit response of CR or PR (i.e., unconfirmed response). CR is defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.

Source null

→

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 · Durvalumab Plus Tremelimumab Versus Placebo: Change From Baseline in Patient-Reported Symptoms as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03703297
qol key
qol-0019
source section id
NCT03703297-om-0019
source outcome index
19
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Durvalumab Plus Tremelimumab Versus Placebo: Change From Baseline in Patient-Reported Symptoms as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ)
measure definition
Patient-reported outcomes for 5 disease related symptoms will be assessed using EORTC QLQ-Core 30 (C30) items questionnaire (fatigue, appetite loss) and EORTC QLQ-Lung Cancer module 13 (LC13) (dyspnea, cough and pain in chest). An outcome variable consisting of a score from 0 to 100 will be derived for each of the symptom scales/symptom items, functional scales, and global health status (GHS) scale with higher scores on GHS/QoL and functioning scales representing better health status/function, but higher scores on symptom scales/items representing greater symptom severity.
time frame
Baseline (Day 1) and up to approximately 89 months
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
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
NCT03703297
trial label
Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy
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.
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
    NCT03703297
    outcome key
    om-0000
    source section id
    NCT03703297-om-0000
    source outcome index
    0
    endpoint
    Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1
    endpoint definition
    PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of objective disease progression (PD) or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.
    time origin
    Response evaluations performed every 8 weeks (q8w) ± 1 week up to 72 weeks, then every 12 weeks (q12w) ± 1 week up to 96 weeks, and then every 24 weeks (q24w) thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The FAS included all randomized participants.
    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
    NCT03703297
    outcome key
    om-0001
    source section id
    NCT03703297-om-0001
    source outcome index
    1
    endpoint
    Durvalumab Versus Placebo: Overall Survival (OS)
    endpoint definition
    OS was defined as the time from the date of randomization until death due to any cause. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.
    time origin
    From date of randomization until death due to any cause, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The FAS included all randomized participants.
    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
    NCT03703297
    outcome key
    om-0002
    source section id
    NCT03703297-om-0002
    source outcome index
    2
    endpoint
    Durvalumab Plus Tremelimumab Combination Versus Placebo: Progression-Free Survival Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1
    endpoint definition
    PFS per RECIST 1.1 assessed by BICR is defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to progression. PD is defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir.
    time origin
    Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to approximately 89 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    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
    NCT03703297
    outcome key
    om-0003
    source section id
    NCT03703297-om-0003
    source outcome index
    3
    endpoint
    Durvalumab Plus Tremelimumab Combination Versus Placebo: Overall Survival
    endpoint definition
    OS is defined as the time from the date of randomization until death due to any cause.
    time origin
    From date of randomization until death due to any cause, up to approximately 89 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    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
    NCT03703297
    outcome key
    om-0004
    source section id
    NCT03703297-om-0004
    source outcome index
    4
    endpoint
    Durvalumab Versus Placebo: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1
    endpoint definition
    ORR per RECIST 1.1 assessed by BICR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) (i.e., unconfirmed response). CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
    time origin
    Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The FAS included all randomized participants. Only participants with measurable disease at baseline per BICR are reported.
    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
    NCT03703297
    outcome key
    om-0005
    source section id
    NCT03703297-om-0005
    source outcome index
    5
    endpoint
    Durvalumab Plus Tremelimumab Combination Versus Placebo: Objective Response Rate Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1
    endpoint definition
    ORR per RECIST 1.1 assessed by BICR is defined as the percentage of participants with at least 1 visit response of CR or PR (i.e., unconfirmed response). CR is defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
    time origin
    From date of randomization until death due to any cause, up to approximately 89 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    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
    NCT03703297
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Durvalumab
    regimen
    Participants received durvalumab monotherapy (1500 mg for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    analyzed count
    264
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03703297-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03703297
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    analyzed count
    266
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03703297-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03703297
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Durvalumab
    regimen
    Participants received durvalumab monotherapy (1500 mg for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    analyzed count
    264
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03703297-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03703297
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    analyzed count
    266
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03703297-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03703297
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Durvalumab
    regimen
    Participants received durvalumab monotherapy (1500 mg for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    analyzed count
    175
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03703297-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03703297
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
    analyzed count
    169
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03703297-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03703297
    harm key
    EG000
    source section id
    NCT03703297-ae
    event group key
    EG000
    event group label
    Durvalumab
    serious affected
    78
    serious at risk
    262
    other affected
    209
    other at risk
    262
    frequency threshold
    5
    collection period
    From first dose of study drug(Day 1)upto DCO date 15 January 2024(maximum of approximately 1936 days).Safety population:all participants who received at least 1 dose of study drug.Based on results of secondary objectives at interim analysis(reviewed by unblinded IDMC),data for D+T arm were to remain blinded to Sponsor as pre-specified in study's unblinding plan.Since D+T arm was blinded at time of posting results from this interim analysis,results for that arm will be posted at final analysis.
    event definition
    All-cause mortality was assessed for FAS. 1 participant randomized to Durvalumab arm received 2 cycles of tremelimumab and in accordance with SAP was therefore not included in Durva or placebo safety population; will be included in D+T safety population when D+T arm is unblinded.
    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
    NCT03703297
    harm key
    EG001
    source section id
    NCT03703297-ae
    event group key
    EG001
    event group label
    Durvalumab Plus Tremelimumab
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    5
    collection period
    From first dose of study drug(Day 1)upto DCO date 15 January 2024(maximum of approximately 1936 days).Safety population:all participants who received at least 1 dose of study drug.Based on results of secondary objectives at interim analysis(reviewed by unblinded IDMC),data for D+T arm were to remain blinded to Sponsor as pre-specified in study's unblinding plan.Since D+T arm was blinded at time of posting results from this interim analysis,results for that arm will be posted at final analysis.
    event definition
    All-cause mortality was assessed for FAS. 1 participant randomized to Durvalumab arm received 2 cycles of tremelimumab and in accordance with SAP was therefore not included in Durva or placebo safety population; will be included in D+T safety population when D+T arm is unblinded.
    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
    NCT03703297
    harm key
    EG002
    source section id
    NCT03703297-ae
    event group key
    EG002
    event group label
    Placebo
    serious affected
    64
    serious at risk
    265
    other affected
    196
    other at risk
    265
    frequency threshold
    5
    collection period
    From first dose of study drug(Day 1)upto DCO date 15 January 2024(maximum of approximately 1936 days).Safety population:all participants who received at least 1 dose of study drug.Based on results of secondary objectives at interim analysis(reviewed by unblinded IDMC),data for D+T arm were to remain blinded to Sponsor as pre-specified in study's unblinding plan.Since D+T arm was blinded at time of posting results from this interim analysis,results for that arm will be posted at final analysis.
    event definition
    All-cause mortality was assessed for FAS. 1 participant randomized to Durvalumab arm received 2 cycles of tremelimumab and in accordance with SAP was therefore not included in Durva or placebo safety population; will be included in D+T safety population when D+T arm is unblinded.
    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
    NCT03703297
    qol key
    qol-0019
    source section id
    NCT03703297-om-0019
    source outcome index
    19
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Durvalumab Plus Tremelimumab Versus Placebo: Change From Baseline in Patient-Reported Symptoms as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ)
    measure definition
    Patient-reported outcomes for 5 disease related symptoms will be assessed using EORTC QLQ-Core 30 (C30) items questionnaire (fatigue, appetite loss) and EORTC QLQ-Lung Cancer module 13 (LC13) (dyspnea, cough and pain in chest). An outcome variable consisting of a score from 0 to 100 will be derived for each of the symptom scales/symptom items, functional scales, and global health status (GHS) scale with higher scores on GHS/QoL and functioning scales representing better health status/function, but higher scores on symptom scales/items representing greater symptom severity.
    time frame
    Baseline (Day 1) and up to approximately 89 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    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