AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 1/2NCT03974022

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 1/2 study testing Sunvozertinib in people with Non-Small Cell Lung Cancer, run by Dizal Pharmaceuticals at 124 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Sunvozertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
124 sitesin 13 countries
Study dates
9 Jul 2019to Dec 2026
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

124 sites in 13 countries.

124 sites in 13 countries

China33 sites

  • Beijing Cancer Hospital

    Beijing

  • Beijing Chest Hospital，Capital Medical University

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Jilin Cancer Hospital

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • West China Hospital of Sichuan University

    Chengdu

  • Chongqing Cancer Hospital

    Chongqing

  • Fujian Cancer Hospital

    Fuzhou

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou

  • Hainan General Hospital

    Haikou

  • The First Affilated Hospital of Zhejiang University

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • The first Affiliated Hospital of USTC Anhui Provincial Hospital

    Hefei

  • The Second Hospital of Anhui Medical University

    Hefei

  • Henan Cancer Hospital

    Henan

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot

  • The Affiliated Huaian No.1 Peoples Hospital of Nanjing Medical University

    Huai'an

  • Jinan Central Hospital

    Jinan

  • Linyi Cancer Hospital

    Linyi

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

  • Guangxi Medical University Cancer Hospital

    Nanning

  • Zhongshan Hospital, Fudan University

    Shanghai

  • The First Hospital of China Medical University

    Shenyang

  • Shanxi Cancer Hospital

    Taiyuan

  • Taizhou Hospital of Zhejiang Province

    Taizhou

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

  • Hubei Cancer Hospital

    Wuhan

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

Spain15 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitari Vall d'Hebrón

    Barcelona

  • ICO (Institut Catala d'Oncologia) Badalona - Hospital Germans Trias i Pujol

    Barcelona

  • Institut Català d'Oncología de Girona - Hospital Universitari de Girona Dr. Josep Trueta

    Girona

  • Hospital de Jeréz

    Jerez de la Frontera

  • Centro Integral Oncológico Clara Campal (CIOCC)

    Madrid

  • Clínica Universidad de Navarra

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid

  • Hospital Regional Universitario de Malaga

    Málaga

  • Hospital Universitario Virgen de Valme

    Seville

  • Hospital Universitario Virgen Macarena

    Seville

  • Hospital La Fe

    Valencia

Other trials in Spain

United States12 sites

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Michigan Center of Medical Research

    Farmington Hills, Michigan, 48334

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

    La Jolla, California, 92093

  • Northwell Health - Centers for Advanced Medicine

    New Hyde Park, New York, 11042-1118

  • Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

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

    Orange, California, 92868

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • Innovative Clinical Research Institute, LLC

    Whittier, California, 90603-2137

Other trials in United States

France12 sites

  • Centre Hospitalier Universitaire d'Angers

    Angers

  • Hospices Civils de Lyon - Hôpital Louis Pradel

    Bron

  • Centre Georges François Leclerc

    Dijon

  • CHU de Lille - Institut Coeur Poumons

    Hellemmes-Lille

  • Hôpital de La Timone AP-Hm

    Marseille

  • CHU de Montpellier Hôpital Arnaud de Villeneuve

    Montpellier

  • APHP-Hôpital Bichat - Claude Bernard

    Paris

  • CHU de Poitiers

    Poitiers

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain

  • HIA Begin

    Saint-Mandé

  • CHU de Toulouse - Hôpital Larrey

    Toulouse

  • Institut Gustave ROUSSY

    Villejuif

Other trials in France

Argentina9 sites

  • Fundacion Respirar - Consultorios Medicos Dr. Doreski

    Cabildo

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

    Ciudad Autónoma Buenos Aires

  • Centro Medico Austral OMI

    Ciudad Autónoma Buenos Aires

  • Diabaid

    Ciudad Autónoma Buenos Aires

  • Fundacion CENIT Para La Investigacion en Neurociencias

    Ciudad Autónoma Buenos Aires

  • Instituto Argentino de Diagnositco y Tratamiento S.A.

    Ciudad Autónoma Buenos Aires

  • Instituto Medico de la Fundacion de Estudios Clínicos

    Ciudad Autónoma Buenos Aires

  • Centro de Investigación Pergamino SA

    Pergamino

  • Clinica Viedma S.A

    Viedma

Other trials in Argentina

Italy9 sites

  • Centro di Riferimento Oncologico (CRO)

    Aviano

  • Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"

    Catania

  • Azienda Ospedaliero-Universitaria Careggi

    Florence

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS

    Meldola

  • Istituto Europeo di Oncologia

    Milan

  • Azienda Ospedaliero-Universitaria di Parma

    Parma

  • AUSL Romagna - Ospedale S.M delle Croci

    Ravenna

  • Arcispedale Santa Maria Nuova

    Reggio Emilia

  • Istituti Fisioterapici Ospitalieri

    Roma

Other trials in Italy

Australia7 sites

  • Blacktown Hospital

    Blacktown

  • Chris O'Brien Lifehouse

    Camperdown

  • Austin Hospital

    Heidelberg

  • St George Hospital

    Kogarah

  • Peter MacCallum Cancer Centre - East Melbourne

    North Melbourne

  • Linear Cancer trials

    Perth

  • Southern Medical Day Care Centre

    Wollongong

Other trials in Australia

Taiwan7 sites

  • Chi Mei Hospital, Liouying

    Liuying

  • Taichung Veterans General Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Wan Fang Hospital

    Taipei

  • Chang Gung Memorial Hospital

    Taoyuan

Other trials in Taiwan

Japan6 sites

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama

  • Aichi Cancer Center Hospital

    Nagoya

  • Niigata University Medical & Dental Hospital

    Niigata

  • Okayama University Hospital

    Okayama

  • Tokushima University Hospital

    Tokushima

  • Tokyo Shinagawa Hospital

    Tokyo

Other trials in Japan

South Korea6 sites

  • Chungbuk National University Hospital

    Cheonju

  • National Cancer Center

    Goyang

  • Seoul National University Bundang Hospital

    Seongnam

  • Asan Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon

Other trials in South Korea

Chile4 sites

  • Fundación Arturo López Pérez

    Providencia

  • Orlandi Oncología - Centro Médico Health & Care

    Santiago

  • SAGA

    Santiago

  • James Lind Centro De Investigacion Del Cancer

    Temuco

Other trials in Chile

Malaysia3 sites

  • Hospital Sultan Ismail

    Johor Bahru

  • Hospital Kuala Lumpur

    Kuala Lumpur

  • University Malaya Medical Centre

    Kuala Lumpur

Other trials in Malaysia

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed 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).

Being tested
Sunvozertinib
Keywords
Non-Small Cell Lung Cancer, EGFR, HER2, mutation
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SunvozertinibDrug

    Also called DZD9008

    Daily dose of Sunvozertinib

Study groups in NCT03974022
Study groupRoleWhat they receive
Part A Dose escalationExperimentalNot described
Receives: Drug: Sunvozertinib
Part A Dose expansion cohort 1ExperimentalNot described
Receives: Drug: Sunvozertinib
Part A Dose expansion cohort 2ExperimentalNot described
Receives: Drug: Sunvozertinib
Part A Dose expansion cohort 3ExperimentalPatients with EGFR Exon20ins, previously treated with at least one line of systemic therapy
Receives: Drug: Sunvozertinib
Part A Dose expansion cohort 4ExperimentalPatients with EGFR Exon20ins, previously treated with at least one line of systemic therapy
Receives: Drug: Sunvozertinib
Part A Dose expansion cohort 5ExperimentalPatients with EGFR Exon20ins, treatment naïve
Receives: Drug: Sunvozertinib
Part A Dose expansion cohort 6ExperimentalNot described
Receives: Drug: Sunvozertinib
Part B Dose extension cohort 1ExperimentalPatients with EGFR Exon20ins
Receives: Drug: Sunvozertinib
Part B Dose extension cohort 2ExperimentalPatients with EGFR Exon20ins
Receives: Drug: Sunvozertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

  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).

    Measured: through the study completion, an average of around 1 year for part B

Secondary outcomes (16)

  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.

    Measured: Through the study completion, an average of around 1 year for part B

  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.

    Measured: Through the study completion, an average of around 1 year for part B

  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.

    Measured: Through the study completion, an average of around 1 year for part B

  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.

    Measured: 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.

  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.

    Measured: The maximum median of DoR was 19.3 months, and the maximum median of PFS was 12.5 months for part A.

  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.

    Measured: 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.

  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.

    Measured: Cycle 0 Day 1: 0 (predose) up to 168 hours (for Part A escalation); Cycle 1 Day 1: 0 (predose) up to 24 hours (for Part A expansion)

  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.

    Measured: Cycle 0 Day 1: 0 (predose) up to 168 hours (for Part A escalation); Cycle 1 Day 1: 0 (predose) up to 24 hours (for Part A expansion)

  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.

    Measured: Cycle 2 Day 1: 0 (predose) up to 24 hours (for Part A Dose expansion and expansion)

  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.

    Measured: Cycle 2 Day 1: 0 (predose) up to 24 hours (for Part A Dose escalation and expansion)

  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.

    Measured: Day 1 and Day 9: 0 (predose) up to 168 hours.

  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.

    Measured: Day 1 and Day 9: 0 (predose) up to 168 hours.

  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.

    Measured: Cycle 1 Day 1: 0 (predose) up to 24 hours

  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.

    Measured: Cycle 1 Day 1: 0 (predose) up to 24 hours

  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.

    Measured: Cycle 2 Day 1: 0 (predose) up to 24 hours

  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.

    Measured: Cycle 2 Day 1: 0 (predose) up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start9 Jul 2019
  3. Primary completion29 Jul 2024
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03974022
Sponsor's protocol ID
DZ2019E0001
Status last verified
Jan 2026
First submitted
21 May 2019
Last updated
29 Jan 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang JC, Wang M, Doucet L, Fan Y, Lv D, Sun M, Huang D, Greillier L, Planchard D, Hong Q, Mazieres J, Felip E, Li X, Hu Y, Fang J, Bazhenova L, Ghiringhelli F, Cobo Dols MA, Rodriguez LP, Bearz A, Pellini B, Kim YJ, Bosch-Barrera J, Shim BY, Luo YH, Tiseo M, Yang TY, Carcereny E, Memmott RM, Zalcman G, de Castro Carpeno J, Di Noia V, Parra HS, Streich G, Lee DH, Shum E, Han JY, Jaime JC, Brungs D, John T, D'Arcangelo M, Joaquin AB, Liu G, Antonuzzo L, Hinojal GF, Le X, Zheng L, Janne PA; WU-KONG1B. Phase II Dose-Randomized Study of Sunvozertinib in Platinum-Pretreated Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations (WU-KONG1B). J Clin Oncol. 2025 Oct 10;43(29):3198-3208. doi: 10.1200/JCO-25-00788. Epub 2025 Sep 9.

    PubMed 40923280

  • Miyamura BV, Mambetsariev I, Fricke J, Arias-Romero J, Cadman K, Shrestha S, Pisick E, Nguyen D, Malhotra J, Reyes A, Salgia R. Current paradigm of EGFRins20 in non-small cell lung cancer: A long way forward. Med. 2025 Sep 12;6(9):100803. doi: 10.1016/j.medj.2025.100803. Epub 2025 Aug 8.

    PubMed 40782807

  • Luan T, Lin X, Xie X, Yang G, Wang S, Hao J, Zhou C. First case report of sunvozertinib for the treatment of HER2 exon 20 insertion in lung adenocarcinoma. Anticancer Drugs. 2024 Sep 1;35(8):757-760. doi: 10.1097/CAD.0000000000001628. Epub 2024 Jun 26.

    PubMed 38924456

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sunvozertinib in people with Non-Small Cell Lung Cancer, run by Dizal Pharmaceuticals at 124 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in China, Spain, United States, France, Argentina and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A Dose Escalation: Dose Limiting Toxicities (DLTs). (time frame: The DLT observation period is defined as the 28 days after the first multiple dose (up to 36 days from baseline).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03974022, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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