NCT00981058 · OUTCOME

Number of Participants With a Serum Anti-Necitumumab Antibody Assessment

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: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: Baseline through 31 Months

What was measured

A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.

Analysis population: All randomized participants who received who received at least 1 dose of drug and had evaluable data for antibodies.

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

Group	Source count
Necitumumab + Gemcitabine + Cisplatin	528

Reported measurements

Participants with at least 1 positive titer

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	81	Not reported	Not reported	Not reported	Not reported

Neutralizing antibody detected

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Necitumumab + Gemcitabine + Cisplatin	5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
81
title
Participants with at least 1 positive titer
categories
measurements
group Id
OG000
value
5
title
Neutralizing antibody detected

denoms

counts
group Id
OG000
value
528
units
Participants

description

A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.

groups

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

NUMBER

population Description

All randomized participants who received who received at least 1 dose of drug and had evaluable data for antibodies.

reporting Status

POSTED

time Frame

Baseline through 31 Months

title

Number of Participants With a Serum Anti-Necitumumab Antibody Assessment

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice