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NCT00982111 · OUTCOME

Percentage of Participants With EGFR Measured by IHC

First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin · Source last updated 2022-01-11

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
Not reported
Time frame
Baseline

What was measured

EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of \< 200 and participants with a high EGFR expression defined by a H-score of cutoff value of \>=200.

Analysis population: Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment

Groups in this outcome

Necitumumab + Pemetrexed + Cisplatin

Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

Pemetrexed + Cisplatin

Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, 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 + Pemetrexed + Cisplatin245
Pemetrexed + Cisplatin245

Reported measurements

H-score <200

Analysis denominator · Participants

GroupSource count
Necitumumab + Pemetrexed + Cisplatin144
Pemetrexed + Cisplatin146
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Necitumumab + Pemetrexed + Cisplatin58.8Not reportedNot reportedNot reportedNot reported
Pemetrexed + Cisplatin59.6Not reportedNot reportedNot reportedNot reported
H-score >=200

Analysis denominator · Participants

GroupSource count
Necitumumab + Pemetrexed + Cisplatin101
Pemetrexed + Cisplatin99
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Necitumumab + Pemetrexed + Cisplatin41.2Not reportedNot reportedNot reportedNot reported
Pemetrexed + Cisplatin40.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        58.8
      2. group Id
        OG001
        value
        59.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        144
      2. group Id
        OG001
        value
        146
      units
      Participants
    title
    H-score <200
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        41.2
      2. group Id
        OG001
        value
        40.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        101
      2. group Id
        OG001
        value
        99
      units
      Participants
    title
    H-score >=200
denoms
  1. counts
    1. group Id
      OG000
      value
      245
    2. group Id
      OG001
      value
      245
    units
    Participants
description
EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of \< 200 and participants with a high EGFR expression defined by a H-score of cutoff value of \>=200.
groups
  1. description
    Necitumumab + Pemetrexed + Cisplatin Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    id
    OG000
    title
    Necitumumab + Pemetrexed + Cisplatin
  2. description
    Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    id
    OG001
    title
    Pemetrexed + Cisplatin
param Type
NUMBER
population Description
Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment
reporting Status
POSTED
time Frame
Baseline
title
Percentage of Participants With EGFR Measured by IHC
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice