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NCT00981058 · OUTCOME

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab

First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin · Source last updated 2025-06-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
micrograms/milliliter (ug/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months

Analysis population: All randomized participants who received at least one dose of study drug and had evaluable data for PK.

Groups in this outcome

Necitumumab + Gemcitabine + Cisplatin

Necitumumab + Gemcitabine + Cisplatin Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.

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

Analysis denominator · Participants

GroupSource count
Necitumumab + Gemcitabine + Cisplatin545

Reported measurements

Predose Cycle 2 Day 1 (n=419)
Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Necitumumab + Gemcitabine + Cisplatin52.495.9Not reportedNot reportedNot reported
Predose Cycle3 Day 1 (n=386)
Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Necitumumab + Gemcitabine + Cisplatin76.680.6Not reportedNot reportedNot reported
Predose Cycle 4 Day 1 (n=344)
Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Necitumumab + Gemcitabine + Cisplatin94.592.2Not reportedNot reportedNot reported
Predose Cycle 5 Day 1 (n=297)
Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Necitumumab + Gemcitabine + Cisplatin10190Not reportedNot reportedNot reported
Predose Cycle 6 Day 1 (n=262)
Values in micrograms/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Necitumumab + Gemcitabine + Cisplatin98.580Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        95.9
        value
        52.4
    title
    Predose Cycle 2 Day 1 (n=419)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        80.6
        value
        76.6
    title
    Predose Cycle3 Day 1 (n=386)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        92.2
        value
        94.5
    title
    Predose Cycle 4 Day 1 (n=344)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        90
        value
        101
    title
    Predose Cycle 5 Day 1 (n=297)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        80
        value
        98.5
    title
    Predose Cycle 6 Day 1 (n=262)
denoms
  1. counts
    1. group Id
      OG000
      value
      545
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Necitumumab + Gemcitabine + Cisplatin Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
    id
    OG000
    title
    Necitumumab + Gemcitabine + Cisplatin
param Type
GEOMETRIC_MEAN
population Description
All randomized participants who received at least one dose of study drug and had evaluable data for PK.
reporting Status
POSTED
time Frame
Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months
title
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
type
SECONDARY
unit Of Measure
micrograms/milliliter (ug/mL)

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

Preserved source evidence · Not medical advice