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

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified December 2025 by Dizal Pharmaceuticals
Sponsor
Dizal Pharmaceuticals
Information Provided by (Responsible Party)
Dizal Pharmaceuticals
Clinicaltrials.gov Identifier
NCT03974022
Other Study ID Numbers:
DZ2019E0001
First Submitted
May 20, 2019
First Posted
June 3, 2019
Results First Posted
July 27, 2025
Last Update Posted
January 28, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of Sunvozertinib in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation. This study includes dose escalation, dose expansion, food effect (Part A) and dose extension (Part B).

Condition or DiseaseIntervention/Treatment
Non-Small Cell Lung Cancer
Drug: SunvozertinibDrug: SunvozertinibDrug: SunvozertinibDrug: SunvozertinibDrug: SunvozertinibDrug: SunvozertinibDrug: SunvozertinibDrug: SunvozertinibDrug: Sunvozertinib

Study Design

Study TypeInterventional
Actual Enrollment315 participants
Design AllocationNon-Randomized
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateJuly 8, 2019
Actual Primary Completion DateJuly 28, 2024
Actual Study Completion Date6mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Part A Dose escalation
Drug: Sunvozertinib
Daily dose of Sunvozertinib
Part A Dose expansion cohort 1
Drug: Sunvozertinib
Daily dose of Sunvozertinib
Part A Dose expansion cohort 2
Drug: Sunvozertinib
Daily dose of Sunvozertinib
Part A Dose expansion cohort 3
Patients with EGFR Exon20ins, previously treated with at least one line of systemic therapy
Drug: Sunvozertinib
Daily dose of Sunvozertinib
Part A Dose expansion cohort 4
Patients with EGFR Exon20ins, previously treated with at least one line of systemic therapy
Drug: Sunvozertinib
Daily dose of Sunvozertinib
Part A Dose expansion cohort 5
Patients with EGFR Exon20ins, treatment naïve
Drug: Sunvozertinib
Daily dose of Sunvozertinib
Part A Dose expansion cohort 6
Drug: Sunvozertinib
Daily dose of Sunvozertinib
Part B Dose extension cohort 1
Patients with EGFR Exon20ins
Drug: Sunvozertinib
Daily dose of Sunvozertinib
Part B Dose extension cohort 2
Patients with EGFR Exon20ins
Drug: Sunvozertinib
Daily dose of Sunvozertinib

Outcome Measures

Primary Outcome Measures
  1. 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.
  2. 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).
Secondary Outcome Measures
  1. Part B: DCR According to RECIST 1.1 Using Assessments Performed by an IRC; DCR Using Investigators Assessments According to RECIST 1.1
    To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.
  2. 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
    To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.
  3. Part B: AEs/SAEs
    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.
  4. Part A: Confirmed ORR and DCR by Investigator.
    To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator. Confirmed ORR was defined as the percentage of patients achieving a CR (Complete Response) or PR (Partial Response) and was confirmed by subsequent tumor assessment at least 4 weeks within the study period. Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by a subsequent tumor assessment at least 4 weeks within the study period. Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.
  5. Part A: DoR and PFS by Investigator.
    To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator. DoR was presented for patients with confirmed objective response (CR or PR). DoR was the time from date of first documentation of CR or PR, which was subsequently confirmed, to date of first documentation of objective progression or death. Patients who had no documentation of objective progression or death was censored. PFS was the time from first dose date of sunvozertinib to date of first documentation of progression or death due to any cause, whichever occurred first. Patient who had no PFS event was censored.
  6. Part A: Confirmed ORR and DCR by Independent Review Committee (IRC).
    To retrospectively assess anti-tumor activity of sunvozertinib in treatment-naive NSCLC patients with EGFR Exon20ins according to RECIST 1.1 by IRC. Confirmed ORR was defined as the percentage of patients achieving a CR or PR and was confirmed by subsequent tumor assessment at least 4 weeks within the study period. Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by subsequent tumor assessment at least 4 weeks within the study period. Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.
  7. Part A Dose Escalation and Expansion: Maximum Plasma Concentration (Cmax) of DZD9008
    Maximum observed plasma concentration (ng/mL), obtained directly from the observed concentration versus time data. Calculated for the single dose.
  8. Part A Dose Escalation and Expansion: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008
    Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.
  9. Part A Dose Escalation and Expansion: Cmax,ss, at Steady State of DZD9008
    Maximum observed plasma concentration(ng/mL), at steady state, obtained directly from the observed concentration versus time data. Calculated for the multiple dose.
  10. Part A Dose Escalation and Expansion: AUCss, at Steady State of DZD9008
    Area under the plasma concentration-time curve in the dose interval at steady state, calculated by the linear up/log down rule.
  11. Part A Food Effect: Maximum Plasma Concentration (Cmax) of DZD9008
    Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose, in the fasted or fed state.
  12. Part A Food Effect: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008
    Area under the plasma concentration-time-curve from time zero the last quantifiable time point, calculated by the linear up/log down rule, in the fasted or fed state.
  13. Part B: Maximum Plasma Concentration (Cmax) of DZD9008 and DZ0753
    Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose.
  14. Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008 and DZ0753.
    Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.
  15. Part B: Cmax,ss, at Steady State of DZD9008 and DZ0753
    Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the multiple dose.
  16. Part B: AUCss, at Steady State of DZD9008 and DZ0753.
    Area under the plasma concentration-time curve from time zero in the dose interval at steady state, calculated by the linear up/log down rule.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Aged at least 18 years old, be able to provide a signed and dated, written informed consent. 2. With documented histological or cytological confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations. 3. (ECOG) performance status 0-1. 4. Predicted life expectancy ≥ 12 weeks 5. Patient must have measurable disease according to RECIST 1.1. 6. 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. 7. Adequate organ system function. 8. 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: 9. 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. 10. Patients should have received at least 1 line, but no more than 3 lines of systemic therapy for metastatic/locally advanced disease.
Exclusion Criteria
1. 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. 2. 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. 3. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before the first administration. 4. 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. 5. 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. 6. 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. 7. Spinal cord compression or leptomeningeal metastasis. 8. 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). 9. 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. 10. 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. 11. 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. 12. History of hypersensitivity to active or inactive excipients of Sunvozertinib or drugs with a similar chemical structure or class to Sunvozertinib. 13. Women who are pregnant or breast feeding. 14. Involvement in the planning and conduct of the study. 15. 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.

Contacts and Locations

Sponsors and CollaboratorsDizal Pharmaceuticals
Locations
University of California, San Diego (UCSD) - Moores Cancer Center | La Jolla California, United States, 92093University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center | Orange California, United States, 92868Innovative Clinical Research Institute, LLC | Whittier California, United States, 90603-2137University of Colorado Hospital - Anschutz Cancer Pavilion | Aurora Colorado, United States, 80045H. Lee Moffitt Cancer Center & Research Institute | Tampa Florida, United States, 33612Dana-Farber Cancer Institute | Boston Massachusetts, United States, 02215Michigan Center of Medical Research | Farmington Hills Michigan, United States, 48334Northwell Health - Centers for Advanced Medicine | New Hyde Park New York, United States, 11042-1118Laura and Isaac Perlmutter Cancer Center | New York New York, United States, 10016Icahn School of Medicine at Mount Sinai | New York New York, United States, 10029The Ohio State University Comprehensive Cancer Center | Columbus Ohio, United States, 43210-1240Virginia Cancer Specialists | Fairfax Virginia, United States, 22031Fundacion Respirar - Consultorios Medicos Dr. Doreski | Cabildo , Argentina, CEMIC Centro de Educación Médica e Investigaciones Clínicas - Hospital Universitario sede Saavedra | Ciudad Autónoma Buenos Aires , Argentina, Centro Medico Austral OMI | Ciudad Autónoma Buenos Aires , Argentina, Diabaid | Ciudad Autónoma Buenos Aires , Argentina, Fundacion CENIT Para La Investigacion en Neurociencias | Ciudad Autónoma Buenos Aires , Argentina, Instituto Argentino de Diagnositco y Tratamiento S.A. | Ciudad Autónoma Buenos Aires , Argentina, Instituto Medico de la Fundacion de Estudios Clínicos | Ciudad Autónoma Buenos Aires , Argentina, Centro de Investigación Pergamino SA | Pergamino , Argentina, Clinica Viedma S.A | Viedma , Argentina, Blacktown Hospital | Blacktown , Australia, Chris O'Brien Lifehouse | Camperdown , Australia, Austin Hospital | Heidelberg , Australia, St George Hospital | Kogarah , Australia, Peter MacCallum Cancer Centre - East Melbourne | North Melbourne , Australia, Linear Cancer trials | Perth , Australia, Southern Medical Day Care Centre | Wollongong , Australia, Princess Margaret Cancer Centre | Toronto , Canada, Fundación Arturo López Pérez | Providencia , Chile, Orlandi Oncología - Centro Médico Health & Care | Santiago , Chile, SAGA | Santiago , Chile, James Lind Centro De Investigacion Del Cancer | Temuco , Chile, Beijing Cancer Hospital | Beijing , China, Beijing Chest Hospital，Capital Medical University | Beijing , China, Peking Union Medical College Hospital | Beijing , China, Jilin Cancer Hospital | Changchun , China, Hunan Cancer Hospital | Changsha , China, West China Hospital of Sichuan University | Chengdu , China, Chongqing Cancer Hospital | Chongqing , China, Fujian Cancer Hospital | Fuzhou , 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 Affilated Hospital of Zhejiang University | Hangzhou , China, Zhejiang Cancer Hospital | Hangzhou , China, Harbin Medical University Cancer Hospital | Harbin , China, The first Affiliated Hospital of USTC Anhui Provincial Hospital | Hefei , China, The Second Hospital of Anhui Medical University | Hefei , China, Henan Cancer Hospital | Henan , China, The Affiliated Hospital of Inner Mongolia Medical University | Hohhot , China, The Affiliated Huaian No.1 Peoples Hospital of Nanjing Medical University | Huai'an , China, Jinan Central Hospital | Jinan , China, Linyi Cancer Hospital | Linyi , China, The First Affiliated Hospital of Nanchang University | Nanchang , China, The Second Affiliated Hospital of Nanchang University | Nanchang , China, Guangxi Medical University Cancer Hospital | Nanning , China, Zhongshan Hospital, Fudan University | Shanghai , China, The First Hospital of China Medical University | Shenyang , China, Shanxi Cancer Hospital | Taiyuan , China, Taizhou Hospital of Zhejiang Province | Taizhou , China, Tianjin Medical University Cancer Institute & Hospital | Tianjin , China, Hubei Cancer Hospital | Wuhan , China, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan , China, The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an , China, The First Affiliated Hospital of Zhengzhou University | Zhengzhou , China, Centre Hospitalier Universitaire d'Angers | Angers , France, Hospices Civils de Lyon - Hôpital Louis Pradel | Bron , France, Centre Georges François Leclerc | Dijon , France, CHU de Lille - Institut Coeur Poumons | Hellemmes-Lille , France, Hôpital de La Timone AP-Hm | Marseille , France, CHU de Montpellier Hôpital Arnaud de Villeneuve | Montpellier , France, APHP-Hôpital Bichat - Claude Bernard | Paris , France, CHU de Poitiers | Poitiers , France, Institut de Cancérologie de l'Ouest | Saint-Herblain , France, HIA Begin | Saint-Mandé , France, CHU de Toulouse - Hôpital Larrey | Toulouse , France, Institut Gustave ROUSSY | Villejuif , France, Centro di Riferimento Oncologico (CRO) | Aviano , Italy, Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" | Catania , Italy, Azienda Ospedaliero-Universitaria Careggi | Florence , Italy, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS | Meldola , Italy, Istituto Europeo di Oncologia | Milan , Italy, Azienda Ospedaliero-Universitaria di Parma | Parma , Italy, AUSL Romagna - Ospedale S.M delle Croci | Ravenna , Italy, Arcispedale Santa Maria Nuova | Reggio Emilia , Italy, Istituti Fisioterapici Ospitalieri | Roma , Italy, National Hospital Organization Shikoku Cancer Center | Matsuyama , Japan, Aichi Cancer Center Hospital | Nagoya , Japan, Niigata University Medical & Dental Hospital | Niigata , Japan, Okayama University Hospital | Okayama , Japan, Tokushima University Hospital | Tokushima , Japan, Tokyo Shinagawa Hospital | Tokyo , Japan, Hospital Sultan Ismail | Johor Bahru , Malaysia, Hospital Kuala Lumpur | Kuala Lumpur , Malaysia, University Malaya Medical Centre | Kuala Lumpur , Malaysia, Chungbuk National University Hospital | Cheonju , South Korea, National Cancer Center | Goyang , South Korea, Seoul National University Bundang Hospital | Seongnam , South Korea, Asan Medical Center | Seoul , South Korea, Seoul National University Hospital | Seoul , South Korea, The Catholic University of Korea, St. Vincent's Hospital | Suwon , South Korea, Hospital de la Santa Creu i Sant Pau | Barcelona , Spain, Hospital Universitari Vall d'Hebrón | Barcelona , Spain, ICO (Institut Catala d'Oncologia) Badalona - Hospital Germans Trias i Pujol | Barcelona , Spain, Institut Català d'Oncología de Girona - Hospital Universitari de Girona Dr. Josep Trueta | Girona , Spain, Hospital de Jeréz | Jerez de la Frontera , Spain, Centro Integral Oncológico Clara Campal (CIOCC) | Madrid , Spain, Clínica Universidad de Navarra | Madrid , Spain, Hospital Universitario 12 de Octubre | Madrid , Spain, Hospital Universitario Fundacion Jimenez Diaz | Madrid , Spain, Hospital Universitario La Paz | Madrid , Spain, Hospital Universitario Ramón y Cajal | Madrid , Spain, Hospital Regional Universitario de Malaga | Málaga , Spain, Hospital Universitario Virgen de Valme | Seville , Spain, Hospital Universitario Virgen Macarena | Seville , Spain, Hospital La Fe | Valencia , Spain, Chi Mei Hospital, Liouying | Liuying , Taiwan, Taichung Veterans General Hospital | Taichung , Taiwan, National Cheng Kung University Hospital | Tainan , Taiwan, National Taiwan University Hospital | Taipei , Taiwan, Taipei Veterans General Hospital | Taipei , Taiwan, Wan Fang Hospital | Taipei , Taiwan, Chang Gung Memorial Hospital | Taoyuan , Taiwan,
Investigators
Principal Investigator: Pasi Antero Jänne, M.D & Ph. D, Dana-Farber Cancer Institute
Study Documents (Full Text)
Documents provided by Dizal Pharmaceuticals: Study Protocol  July 23, 2023Documents provided by Dizal Pharmaceuticals: Statistical Analysis Plan  November 15, 2023