NCT03974022 · OUTCOME

Part A Dose Escalation: Dose Limiting Toxicities (DLTs).

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: The DLT observation period is defined as the 28 days after the first multiple dose (up to 36 days from baseline).

What was measured

To evaluate the safety and tolerability and defined the maximum tolerated dose (MTD) of sunvozertinib. DLT was evaluated in the DLT observation frame.

Analysis population: Patients in part A Dose Escalation Cohorts who met either or both criteria below were included in DLT analysis: * Patients who received the single dose and at least 80% of planned doses of DZD9008 in the first 28-day of repeated dosing and completed minimum required safety evaluations. * Patients who had at least one DLT reported during the DLT period. 1 patient in 100 mg dose level and 1 patient in 300 mg dose level received less than 80% of planned dose were excluded.

Groups in this outcome

Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg

Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.

Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg

Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.

Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg

Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.

Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg

Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.

Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg

Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib 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 A Dose Escalation Cohort 1: Sunvozertinib 50 mg	3
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg	5
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg	3
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg	6
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg	6

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg	0	Not reported	Not reported	Not reported	Not reported
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg	0	Not reported	Not reported	Not reported	Not reported
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg	0	Not reported	Not reported	Not reported	Not reported
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg	1	Not reported	Not reported	Not reported	Not reported
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
1

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
6
group Id
OG004
value
6
units
Participants

description

To evaluate the safety and tolerability and defined the maximum tolerated dose (MTD) of sunvozertinib. DLT was evaluated in the DLT observation frame.

groups

description
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
id
OG000
title
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
description
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
id
OG001
title
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
description
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
id
OG002
title
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
description
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
id
OG003
title
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
description
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
id
OG004
title
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg

param Type

COUNT_OF_PARTICIPANTS

population Description

Patients in part A Dose Escalation Cohorts who met either or both criteria below were included in DLT analysis: * Patients who received the single dose and at least 80% of planned doses of DZD9008 in the first 28-day of repeated dosing and completed minimum required safety evaluations. * Patients who had at least one DLT reported during the DLT period. 1 patient in 100 mg dose level and 1 patient in 300 mg dose level received less than 80% of planned dose were excluded.

reporting Status

POSTED

time Frame

The DLT observation period is defined as the 28 days after the first multiple dose (up to 36 days from baseline).

title

Part A Dose Escalation: Dose Limiting Toxicities (DLTs).

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice