Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)
NCT ID: NCT05712902
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
104 participants
INTERVENTIONAL
2021-07-19
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Daily dose of Sunvozertinib
Sunvozertinib
Daily dose of Sunvozertinib
Interventions
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Sunvozertinib
Daily dose of Sunvozertinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged at least 18 years old.
3. Histological or cytological confirmed locally advanced or metastatic NSCLC
4. Tumor tissue EGFR exon 20 insertion mutations confirmed by qualified local laboratories or sponsor-designated central laboratories.
5. Participants must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 at ICF signature with no deterioration over the past 2 weeks.
6. Predicted life expectancy ≥ 12 weeks.
7. Patient must have measurable disease according to RECIST 1.1.
8. Patients with brain metastasis (BM) can only be enrolled under the condition that BM is previously treated and stable.
9. Adequate organ system functions.
10. 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).
Exclusion Criteria
2. 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.
3. Spinal cord compression or leptomeningeal metastasis.
4. History of stroke or intracranial hemorrhage within 6 months before first administration of Sunvozertinib.
5. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.
6. Active infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV) and COVID-19.
7. 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.
8. Participants with hemorrhagic diseases such as von Willebrand disease.
9. 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.
10. 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.
11. Prior/concomitant therapy
1. Patients who have received prior Poziotinib, TAK-788, CLN-081 or BDTX-189, furmonertinib or any other EGFR/HER2 exon20ins small molecule inhibitors treatment should be excluded.
2. Other EGFR TKIs, such as gefitinib, erlotinib, osimertinib, afatinib, dacomitinb are not considered EGFR or HER2 Exon20ins small molecule inhibitors, and thus prior treatment with these drugs is allowed unless the patient had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.
3. Treatment with antibodies within 4 weeks before first administration of Sunvozertinib.
4. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before first administration of Sunvozertinib.
12. Women who are pregnant or breast feeding.
18 Years
ALL
No
Sponsors
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Dizal Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Mengzhao Wang
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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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
Countries
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References
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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.
Other Identifiers
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DZ2020E0001
Identifier Type: -
Identifier Source: org_study_id