NCT04644237 · OUTCOME

Number of Participants With Anti-Drug Antibodies (ADA) Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer Tumors

Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) · 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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Pre-dose on Day 1 of Cycles 1, 2 and 4, and then every 4 cycles (each cycle is 21 days), up to Cycle 28 and End of Treatment.

Analysis population: The Immunogenicity Analysis Set included all subjects who received at least one dose of the study drug and who had at least one baseline or post-baseline immunogenicity assessment

Groups in this outcome

Trastuzumab Deruxtecan 5.4 mg/kg

Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).

Trastuzumab Deruxtecan 6.4 mg/kg

Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).

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
Trastuzumab Deruxtecan 5.4 mg/kg	101
Trastuzumab Deruxtecan 6.4 mg/kg	50

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab Deruxtecan 5.4 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Trastuzumab Deruxtecan 6.4 mg/kg	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1

denoms

counts
group Id
OG000
value
101
group Id
OG001
value
50
units
Participants

groups

description
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
id
OG000
title
Trastuzumab Deruxtecan 5.4 mg/kg
description
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
id
OG001
title
Trastuzumab Deruxtecan 6.4 mg/kg

param Type

COUNT_OF_PARTICIPANTS

population Description

The Immunogenicity Analysis Set included all subjects who received at least one dose of the study drug and who had at least one baseline or post-baseline immunogenicity assessment

reporting Status

POSTED

time Frame

Pre-dose on Day 1 of Cycles 1, 2 and 4, and then every 4 cycles (each cycle is 21 days), up to Cycle 28 and End of Treatment.

title

Number of Participants With Anti-Drug Antibodies (ADA) Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer Tumors

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice