NCT03974022|Active Not RecruitingPhase 1ResultsFDA Drug

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Mutation

Dizal Pharmaceuticals ClinicalTrials.gov

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1 other identifier

DZ2019E0001

Study Type

interventional

Target

315

Locations

13 countries

Sites

124

Timeline

RegisteredJun 2019

StartedJul 2019

CompletionDec 2026

Brief Summary

This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

315

participants targeted

Target at P75+ for phase_1 nonsmall-cell-lung-cancer

Timeline

7mo left

Started Jul 2019

Longer than P75 for phase_1 nonsmall-cell-lung-cancer

Geographic Reach

13 countries

124 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.4 years study duration

Study Progress92%

Jul 2019Dec 2026

First Submitted

Initial submission to the registry

May 21, 2019

Completed

14 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed

1 month until next milestone

Study Start

First participant enrolled

July 9, 2019

Completed

5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

December 3, 2025

Completed

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

May 21, 2019

Results QC Date

July 28, 2025

Last Update Submit

January 13, 2026

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung CancerEGFRHER2mutation

Outcome Measures

Primary Outcomes (2)

Part A Dose Escalation: Dose Limiting Toxicities (DLTs).
To evaluate the safety and tolerability and defined the maximum tolerated dose (MTD) of sunvozertinib. DLT was evaluated in the DLT observation frame.
The DLT observation period is defined as the 28 days after the first multiple dose (up to 36 days from baseline).
Part B: Objective Response Rate (ORR) According to RECIST 1.1 by an Independent Review Committee (IRC).
To evaluate anti-tumor activity of Sunvozertinib in advanced NSCLC patients with EGFR Exon20 insertion at defined dose(s) by assessment of Objective Response Rate (ORR).
through the study completion, an average of around 1 year for part B

Secondary Outcomes (16)

Part B: DCR According to RECIST 1.1 Using Assessments Performed by an IRC; DCR Using Investigators Assessments According to RECIST 1.1
Through the study completion, an average of around 1 year for part B
Part B: DoR, PFS According to RECIST 1.1 Using Assessments Performed by an IRC; DoR, PFS Using Investigators Assessments According to RECIST 1.1
Through the study completion, an average of around 1 year for part B
Part B: AEs/SAEs
Through the study completion, an average of around 1 year for part B
Part A: Confirmed ORR and DCR by Investigator.
The study duration was from the initiation of sunvozertinib treatment until the study completion. The median study duration was 10 months, and the maximal study duration was 51.4 months for part A.
Part A: DoR and PFS by Investigator.
The maximum median of DoR was 19.3 months, and the maximum median of PFS was 12.5 months for part A.
+11 more secondary outcomes

Study Arms (9)

Part A Dose escalation

EXPERIMENTAL

Drug: Sunvozertinib

Part A Dose expansion cohort 1

EXPERIMENTAL

Drug: Sunvozertinib

Part A Dose expansion cohort 2

EXPERIMENTAL

Drug: Sunvozertinib

Part A Dose expansion cohort 3

EXPERIMENTAL

Patients with EGFR Exon20ins, previously treated with at least one line of systemic therapy

Drug: Sunvozertinib

Part A Dose expansion cohort 4

EXPERIMENTAL

Patients with EGFR Exon20ins, previously treated with at least one line of systemic therapy

Drug: Sunvozertinib

Part A Dose expansion cohort 5

EXPERIMENTAL

Patients with EGFR Exon20ins, treatment naïve

Drug: Sunvozertinib

Part A Dose expansion cohort 6

EXPERIMENTAL

Drug: Sunvozertinib

Part B Dose extension cohort 1

EXPERIMENTAL

Patients with EGFR Exon20ins

Drug: Sunvozertinib

Part B Dose extension cohort 2

EXPERIMENTAL

Patients with EGFR Exon20ins

Drug: Sunvozertinib

Interventions

SunvozertinibDRUG

Daily dose of Sunvozertinib

Also known as: DZD9008

Part A Dose escalationPart A Dose expansion cohort 1Part A Dose expansion cohort 2Part A Dose expansion cohort 3Part A Dose expansion cohort 4Part A Dose expansion cohort 5Part A Dose expansion cohort 6Part B Dose extension cohort 1Part B Dose extension cohort 2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged at least 18 years old, be able to provide a signed and dated, written informed consent.
With documented histological or cytological confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations.
(ECOG) performance status 0-1.
Predicted life expectancy ≥ 12 weeks
Patient must have measurable disease according to RECIST 1.1.
Patients with brain metastasis (BM) can be enrolled under the condition that BM is previously treated and stable, neurologically asymptomatic and does not require corticosteroid treatment.
Adequate organ system function.
Part A Dose expansion: Dose expansion cohort 5: NSCLC patients with EGFR Exon20ins, who have not received prior systemic therapy (treatment naïve).
Part B Dose extension:
Patients must have histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented EGFR Exon20ins mutation in tumor tissue from a local CLIA-certified laboratory (or equivalent) or Sponsor designated central laboratory prior to the study entry.
Patients should have received at least 1 line, but no more than 3 lines of systemic therapy for metastatic/locally advanced disease.

You may not qualify if:

For part B: Patients who have received prior treatment with Poziotinib or TAK788 or other EGFR/HER2 exon20 insertion inhibitors should be excluded. Prior treatment with currently approved EGFR TKIs for sensitizing or T790M resistance mutations, such as gefitinib, erlotinib, osimertinib, afatinib and dacomitinib, are allowed unless the patient had an objective response and subsequent progression assessed by the investigator.
Treatment with EGFR or HER2 antibodies, major surgery (excluding placement of vascular access), or onco-immunotherapy (e.g. immune checkpoint inhibitors PD-1, PD-L1, CTLA-4) within 4 weeks before the first administration of Sunvozertinib.
Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before the first administration.
Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose or with a wide field of radiation which must be completed within 4 weeks before the first administration.
Receiving (or unable to stop using) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A within 1-2 weeks before the first administration.
Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting Sunvozertinib with the exception of alopecia and grade 2 prior platinum-therapy related neuropathy.
Spinal cord compression or leptomeningeal metastasis.
As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV) and COVID-19 (per local practice).
Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 electrocardiograms (ECGs); (2) Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval \> 250 msec. (3) Any factors that increase the risk of QTF prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval; (4) Prior history of atrial fibrillation within 6 months of first administration of Sunvozertinib, except prior drug treatment related and recovered.
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Sunvozertinib.
History of hypersensitivity to active or inactive excipients of Sunvozertinib or drugs with a similar chemical structure or class to Sunvozertinib.
Women who are pregnant or breast feeding.
Involvement in the planning and conduct of the study.
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Dizal Pharmaceuticalslead

Study Sites (124)

University of California, San Diego (UCSD) - Moores Cancer Center

La Jolla, California, 92093, United States

Location

University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Innovative Clinical Research Institute, LLC

Whittier, California, 90603-2137, United States

Location

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Michigan Center of Medical Research

Farmington Hills, Michigan, 48334, United States

Location

Northwell Health - Centers for Advanced Medicine

New Hyde Park, New York, 11042-1118, United States

Location

Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Fundacion Respirar - Consultorios Medicos Dr. Doreski

Cabildo, Argentina

Location

CEMIC Centro de Educación Médica e Investigaciones Clínicas - Hospital Universitario sede Saavedra