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NCT03703297 · OUTCOME

Durvalumab: Serum Concentration of Durvalumab

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
MEAN
Unit
microgram per milliliter (mcg/mL)
Interval / dispersion
Standard Deviation
Time frame
End of infusion on Cycle 1 Day 1, pre-infusion on Cycle 2 (Week 4), Cycle 5 (Week 16) and Cycle 26 (Week 100) and Month 3 post last dose of study treatment (Week 119) (each treatment cycle is 28 days)

What was measured

Blood samples were collected to determine the concentration of durvalumab.

Analysis population: The pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug per the protocol for whom any post-dose data were available and who did not violate or deviate from the protocol in ways that would have significantly affected the PK analyses. Only those participants with data collected at specified timepoints are reported.

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.

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

Analysis denominator · Participants

GroupSource count
Durvalumab222

Reported measurements

Cycle 1 Day 1: End of infusion

Analysis denominator · Participants

GroupSource count
Durvalumab222
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Durvalumab431.00327.861Not reportedNot reportedNot reported
Cycle 2 (Week 4): Pre-infusion

Analysis denominator · Participants

GroupSource count
Durvalumab215
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Durvalumab89.57107.228Not reportedNot reportedNot reported
Cycle 5 (Week 16): Pre-infusion

Analysis denominator · Participants

GroupSource count
Durvalumab119
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Durvalumab159.6358.561Not reportedNot reportedNot reported
Cycle 26 (Week 100): Pre-infusion

Analysis denominator · Participants

GroupSource count
Durvalumab46
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Durvalumab178.2065.422Not reportedNot reportedNot reported
Month 3 follow-up

Analysis denominator · Participants

GroupSource count
Durvalumab118
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Durvalumab44.9736.026Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        327.861
        value
        431.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        222
      units
      Participants
    title
    Cycle 1 Day 1: End of infusion
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        107.228
        value
        89.57
    denoms
    1. counts
      1. group Id
        OG000
        value
        215
      units
      Participants
    title
    Cycle 2 (Week 4): Pre-infusion
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        58.561
        value
        159.63
    denoms
    1. counts
      1. group Id
        OG000
        value
        119
      units
      Participants
    title
    Cycle 5 (Week 16): Pre-infusion
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.422
        value
        178.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      units
      Participants
    title
    Cycle 26 (Week 100): Pre-infusion
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.026
        value
        44.97
    denoms
    1. counts
      1. group Id
        OG000
        value
        118
      units
      Participants
    title
    Month 3 follow-up
denoms
  1. counts
    1. group Id
      OG000
      value
      222
    units
    Participants
description
Blood samples were collected to determine the concentration of durvalumab.
dispersion Type
Standard Deviation
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
param Type
MEAN
population Description
The pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug per the protocol for whom any post-dose data were available and who did not violate or deviate from the protocol in ways that would have significantly affected the PK analyses. Only those participants with data collected at specified timepoints are reported.
reporting Status
POSTED
time Frame
End of infusion on Cycle 1 Day 1, pre-infusion on Cycle 2 (Week 4), Cycle 5 (Week 16) and Cycle 26 (Week 100) and Month 3 post last dose of study treatment (Week 119) (each treatment cycle is 28 days)
title
Durvalumab: Serum Concentration of Durvalumab
type
SECONDARY
unit Of Measure
microgram per milliliter (mcg/mL)

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Preserved source evidence · Not medical advice