NCT03974022 · OUTCOME

Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008 and DZ0753.

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) · Source last updated 2026-01-29

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

Measure: GEOMETRIC_MEAN
Unit: h*ng/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1 Day 1: 0 (predose) up to 24 hours

What was measured

Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.

Analysis population: All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.

Groups in this outcome

Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg

Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 200 mg once daily continuously.

Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg

Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 300 mg once daily continuously.

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
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	22
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	21

Reported measurements

Part B: AUC0-t of DZD9008

Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	2423	71.9	Not reported	Not reported	Not reported
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	4397	55.7	Not reported	Not reported	Not reported

Part B: AUC0-t of DZ0753

Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	200.4	125.2	Not reported	Not reported	Not reported
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	448.5	69.9	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
71.9
value
2423
group Id
OG001
spread
55.7
value
4397
title
Part B: AUC0-t of DZD9008
categories
measurements
group Id
OG000
spread
125.2
value
200.4
group Id
OG001
spread
69.9
value
448.5
title
Part B: AUC0-t of DZ0753

denoms

counts
group Id
OG000
value
22
group Id
OG001
value
21
units
Participants

description

Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.

dispersion Type

Geometric Coefficient of Variation

groups

description
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 200 mg once daily continuously.
id
OG000
title
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
description
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive sunvozertinib 300 mg once daily continuously.
id
OG001
title
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg

param Type

GEOMETRIC_MEAN

population Description

All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.

reporting Status

POSTED

time Frame

Cycle 1 Day 1: 0 (predose) up to 24 hours

title

Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008 and DZ0753.

type

SECONDARY

unit Of Measure

h*ng/mL

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

Preserved source evidence · Not medical advice