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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Sunvozertinib

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).

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A Dose escalation	Drug: Sunvozertinib; Daily dose of Sunvozertinib; Other Names: DZD9008
Experimental: Part A Dose expansion cohort 1	Drug: Sunvozertinib; Daily dose of Sunvozertinib; Other Names: DZD9008
Experimental: Part A Dose expansion cohort 2	Drug: Sunvozertinib; Daily dose of Sunvozertinib; Other Names: DZD9008
Experimental: 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; Other Names: DZD9008
Experimental: Part A Dose expansion cohort 6	Drug: Sunvozertinib; Daily dose of Sunvozertinib; Other Names: DZD9008
Experimental: 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; Other Names: DZD9008
Experimental: Part A Dose expansion cohort 5; Patients with EGFR Exon20ins, treatment naïve	Drug: Sunvozertinib; Daily dose of Sunvozertinib; Other Names: DZD9008
Experimental: Part B Dose extension cohort 1; Patients with EGFR Exon20ins	Drug: Sunvozertinib; Daily dose of Sunvozertinib; Other Names: DZD9008
Experimental: Part B Dose extension cohort 2; Patients with EGFR Exon20ins	Drug: Sunvozertinib; Daily dose of Sunvozertinib; Other Names: DZD9008

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.	Through the study completion, an average of around 1 year for part B
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.	Through the study completion, an average of around 1 year for part B
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.	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.	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.	The maximum median of DoR was 19.3 months, and the maximum median of PFS was 12.5 months for part A.
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.	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 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.	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)
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.	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)
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.	Cycle 2 Day 1: 0 (predose) up to 24 hours (for Part A Dose expansion and expansion)
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.	Cycle 2 Day 1: 0 (predose) up to 24 hours (for Part A Dose escalation and expansion)
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.	Day 1 and Day 9: 0 (predose) up to 168 hours.
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.	Day 1 and Day 9: 0 (predose) up to 168 hours.
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.	Cycle 1 Day 1: 0 (predose) up to 24 hours
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.	Cycle 1 Day 1: 0 (predose) up to 24 hours
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.	Cycle 2 Day 1: 0 (predose) up to 24 hours
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.	Cycle 2 Day 1: 0 (predose) up to 24 hours

Collaborators and Investigators

• Sponsor: Dizal Pharmaceuticals
• Investigators: Principal Investigator: Pasi Antero Jänne, M.D & Ph. D, Dana-Farber Cancer Institute

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2019
• Primary Completion (Actual): July 29, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; mutation; HER2; EGFR
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: DZ2019E0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No