Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)
A Phase II, Single Arm, Multicenter Study to Evaluate Anti-tumor Activity, Safety, Tolerability and Pharmacokinetics of DZD9008 in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with EGFR Exon 20 Insertion Mutation
1 other identifier
interventional
104
1 country
33
Brief Summary
This is a Phase II, single-arm, multi-center clinical study to evaluate the anti-tumor efficacy, safety, tolerability and pharmacokinetics of Sunvozertinib in participants with locally advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations whose disease has progressed on prior platinum-based chemotherapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Jul 2021
Typical duration for phase_2 nonsmall-cell-lung-cancer
33 active sites
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
Study Start
First participant enrolled
July 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2022
CompletedFirst Submitted
Initial submission to the registry
January 12, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedDecember 30, 2024
December 1, 2024
1.2 years
January 12, 2023
December 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) according to RECIST 1.1 by an Independent Review Committee (IRC)
From first dosing until disease progression or intolerable adverse events
Study Arms (1)
Daily dose of Sunvozertinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients must be able to understand the nature of the trial and provide a signed and dated, written informed consent form.
- Aged at least 18 years old.
- Histological or cytological confirmed locally advanced or metastatic NSCLC
- Tumor tissue EGFR exon 20 insertion mutations confirmed by qualified local laboratories or sponsor-designated central laboratories.
- Participants must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 at ICF signature with no deterioration over the past 2 weeks.
- Predicted life expectancy ≥ 12 weeks.
- Patient must have measurable disease according to RECIST 1.1.
- Patients with brain metastasis (BM) can only be enrolled under the condition that BM is previously treated and stable.
- Adequate organ system functions.
- Patients should receive at least one line but no more than three lines of prior systemic therapy (at least one line must contain platinum-based therapy).
You may not qualify if:
- Prior malignancy within 2 years requires active treatment, except for adequately treated basal cell skin carcinoma, in situ cervical carcinoma, or other cancer types (to be discussed with Dizal's Study Physician) who has been disease free for \> 2 years with life expectancy \>2 years.
- 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.
- History of stroke or intracranial hemorrhage within 6 months before first administration of Sunvozertinib.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.
- Active infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV) and COVID-19.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 electrocardiograms (ECGs).
- 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.
- Any factors that increase the risk of QTc 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 .
- Prior history of atrial fibrillation within 6 months of first administration of Sunvozertinib, except prior drug treatment related and recovered.
- Participants with hemorrhagic diseases such as von Willebrand disease.
- 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 or immunotherapy induced immune pneumonia.
- 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.
- Prior/concomitant therapy
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Beijing Cancer Hospital
Beijing, China
Beijing Chest Hospital，Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Jilin Cancer Hospital
Changchun, China
Hunan Cancer Hospital(The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, China
West China Hospital of Sichuan University
Chengdu, China
Army Medical Center of PLA
Chongqing, China
Chongqing University Cancer Hospital(Chongqing Cancer Hospital)
Chongqing, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Hainan General Hospital
Haikou, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital (Cancer Hospital of the University of Chinese Academy of Sciences)
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
The Second Hospital of Anhui Medical University
Hefei, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China
Jinan Central Hospital (Central Hospital Affiliated to Shandong First Medical University)
Jinan, China
Yunnan Cancer Hospital
Kunming, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Fudan University Shanghai Cancer Center
Shanghai, China
The First Hospital of China Medical University
Shenyang, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Shanxi Provincial Cancer Hospital
Taiyuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, China
Hubei Cancer Hospital
Wuhan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Affiliated Cancer Hospital of Zhengzhou University(Henan Cancer Hospital)
Zhengzhou, China
Related Publications (1)
Wang M, Fan Y, Sun M, Wang Y, Zhao Y, Jin B, Hu Y, Han Z, Song X, Liu A, Tang K, Ding C, Liang L, Wu L, Gao J, Wang J, Cheng Y, Zhou J, He Y, Dong X, Yao Y, Yu Y, Wang H, Sun S, Huang J, Fang J, Li W, Wang L, Ren X, Zhou C, Hu Y, Zhao D, Yang R, Xu F, Huang Y, Pan Y, Cui J, Xu Y, Yang Z, Shi Y. Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial. Lancet Respir Med. 2024 Mar;12(3):217-224. doi: 10.1016/S2213-2600(23)00379-X. Epub 2023 Dec 12.
PMID: 38101437DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mengzhao Wang
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2023
First Posted
February 6, 2023
Study Start
July 19, 2021
Primary Completion
October 17, 2022
Study Completion
December 31, 2025
Last Updated
December 30, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share