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NCT03703297 · OUTCOME

Durvalumab Versus Placebo: Percentage of Participants Alive at 24 Months From Randomization (OS24)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Month 24

What was measured

OS was defined as the time from the date of randomization until death due to any cause. The OS24 was defined as the Kaplan-Meier estimate of OS at 24 months after randomization.

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durvalumab68.0Not reported61.973.3Not reported
Placebo58.5Not reported52.364.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        61.9
        upper Limit
        73.3
        value
        68.0
      2. group Id
        OG001
        lower Limit
        52.3
        upper Limit
        64.3
        value
        58.5
denoms
  1. counts
    1. group Id
      OG000
      value
      264
    2. group Id
      OG001
      value
      266
    units
    Participants
description
OS was defined as the time from the date of randomization until death due to any cause. The OS24 was defined as the Kaplan-Meier estimate of OS at 24 months after randomization.
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
NUMBER
population Description
The FAS included all randomized participants.
reporting Status
POSTED
time Frame
Month 24
title
Durvalumab Versus Placebo: Percentage of Participants Alive at 24 Months From Randomization (OS24)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice