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NCT03703297 · OUTCOME

Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy · Source last updated 2025-11-21

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
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)

What was measured

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.

Analysis population: The FAS included all randomized participants.

Groups in this outcome

Durvalumab

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.

Placebo

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Durvalumab264
Placebo266

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durvalumab16.6Not reported10.228.2Not reported
Placebo9.2Not reported7.412.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.606
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.950
    estimate Comment
    Hazard ratio and CI calculated using stratified Cox proportional hazards model,adjusting for tumor,node and metastasis(TNM) stage, receipt of prophylactic cranial irradiation(PCI),with treatment as only covariate and ties handled by Efron approach.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.01608
    param Type
    Hazard Ratio (HR)
    param Value
    0.76
    statistical Comment
    The analysis was performed using the stratified log-rank test.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.606
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.950
    estimate Comment
    Hazard ratio and CI calculated using stratified Cox proportional hazards model,adjusting for tumor,node and metastasis(TNM) stage, receipt of prophylactic cranial irradiation(PCI),with treatment as only covariate and ties handled by Efron approach.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.01608
    param Type
    Hazard Ratio (HR)
    param Value
    0.76
    statistical Comment
    The analysis was performed using the stratified log-rank test.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.2
        upper Limit
        28.2
        value
        16.6
      2. group Id
        OG001
        lower Limit
        7.4
        upper Limit
        12.9
        value
        9.2
denoms
  1. counts
    1. group Id
      OG000
      value
      264
    2. group Id
      OG001
      value
      266
    units
    Participants
description
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.
dispersion Type
95% Confidence Interval
groups
  1. description
    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.
    id
    OG000
    title
    Durvalumab
  2. description
    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.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
The FAS included all randomized participants.
reporting Status
POSTED
time Frame
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)
title
Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice