NCT03974022 · OUTCOME

Part B: AEs/SAEs

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: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: Through the study completion, an average of around 1 year for part B

What was measured

To determine the safety and tolerability of Sunvozertinib: Number of Participants With AEs, Number of Participants With SAEs. Using investigator reported AEs according to CTCAE and SAE criteria.

Analysis population: all patients had at least one dose of DZD9008

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 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 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	91
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	111

Reported measurements

Any TEAE

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	91	Not reported	Not reported	Not reported	Not reported
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	111	Not reported	Not reported	Not reported	Not reported

Any treatment- emergent SAE

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg	37	Not reported	Not reported	Not reported	Not reported
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg	41	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
91
group Id
OG001
value
111
title
Any TEAE
categories
measurements
group Id
OG000
value
37
group Id
OG001
value
41
title
Any treatment- emergent SAE

denoms

counts
group Id
OG000
value
91
group Id
OG001
value
111
units
Participants

description

To determine the safety and tolerability of Sunvozertinib: Number of Participants With AEs, Number of Participants With SAEs. Using investigator reported AEs according to CTCAE and SAE criteria.

groups

description
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized 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 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

NUMBER

population Description

all patients had at least one dose of DZD9008

reporting Status

POSTED

time Frame

Through the study completion, an average of around 1 year for part B

title

Part B: AEs/SAEs

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice