NCT03974022 · OUTCOME

Part B: Maximum Plasma Concentration (Cmax) 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: ng/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1 Day 1: 0 (predose) up to 24 hours

What was measured

Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose.

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: Maximum Plasma Concentration (Cmax) of DZD9008

Values in 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	173.4	80.4	Not reported	Not reported	Not reported
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	325.8	73.7	Not reported	Not reported	Not reported

Part B: Maximum Plasma Concentration (Cmax) of DZ0753

Values in 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	18.90	113.4	Not reported	Not reported	Not reported
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	40.40	78.2	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
80.4
value
173.4
group Id
OG001
spread
73.7
value
325.8
title
Part B: Maximum Plasma Concentration (Cmax) of DZD9008
categories
measurements
group Id
OG000
spread
113.4
value
18.90
group Id
OG001
spread
78.2
value
40.40
title
Part B: Maximum Plasma Concentration (Cmax) of DZ0753

denoms

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

description

Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose.

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: Maximum Plasma Concentration (Cmax) of DZD9008 and DZ0753

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice