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NCT00982111 · OUTCOME

Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)

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
participants
Interval / dispersion
Not reported
Time frame
Baseline to Study Completion (Up to 31.6 Months)

What was measured

A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-Necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.

Analysis population: All randomized participants who received at least one dose of necitumumab and had evaluable antibody data.

Groups in this outcome

Necitumumab + Pemextrexed + 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

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 + Pemextrexed + Cisplatin301

Reported measurements

1 Positive Titer
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Necitumumab + Pemextrexed + Cisplatin37Not reportedNot reportedNot reportedNot reported
Antibodies Detected
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Necitumumab + Pemextrexed + Cisplatin18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        37
    title
    1 Positive Titer
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Antibodies Detected
denoms
  1. counts
    1. group Id
      OG000
      value
      301
    units
    Participants
description
A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-Necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.
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 + Pemextrexed + Cisplatin
param Type
NUMBER
population Description
All randomized participants who received at least one dose of necitumumab and had evaluable antibody data.
reporting Status
POSTED
time Frame
Baseline to Study Completion (Up to 31.6 Months)
title
Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice