New pill shows promise against tough lung cancer

NCT ID NCT03974022

Disease control Sponsor: Dizal Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a new daily pill, sunvozertinib (DZD9008), in people with advanced non-small cell lung cancer that has certain genetic mutations (EGFR or HER2) and has worsened after prior treatments. The trial aims to find safe doses and see if the drug can shrink tumors. About 315 participants are enrolled across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Sunvozertinib (also called DZD9008), a daily oral drug
What this could lead to: If it works, this could offer a new treatment option for people with advanced lung cancer that has specific genetic mutations and has stopped responding to other therapies.
What could go wrong: This is an early-phase trial (phase I/II), so the drug may not prove effective or may cause serious side effects. Results are preliminary and need confirmation in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

315 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

APHP-Hôpital Bichat - Claude Bernard

Paris, France
AUSL Romagna - Ospedale S.M delle Croci

Ravenna, Italy
Aichi Cancer Center Hospital

Nagoya, Japan
Arcispedale Santa Maria Nuova

Reggio Emilia, Italy
Asan Medical Center

Seoul, South Korea
Austin Hospital

Heidelberg, Australia
Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"

Catania, Italy
Azienda Ospedaliero-Universitaria Careggi

Florence, Italy
Azienda Ospedaliero-Universitaria di Parma

Parma, Italy
Beijing Cancer Hospital

Beijing, China
Beijing Chest Hospital，Capital Medical University

Beijing, China
Blacktown Hospital

Blacktown, Australia
CEMIC Centro de Educación Médica e Investigaciones Clínicas - Hospital Universitario sede Saavedra

Ciudad Autónoma Buenos Aires, Argentina
CHU de Lille - Institut Coeur Poumons

Hellemmes-Lille, France
CHU de Montpellier Hôpital Arnaud de Villeneuve

Montpellier, France
CHU de Poitiers

Poitiers, France
CHU de Toulouse - Hôpital Larrey

Toulouse, France
Centre Georges François Leclerc

Dijon, France
Centre Hospitalier Universitaire d'Angers

Angers, France
Centro Integral Oncológico Clara Campal (CIOCC)

Madrid, Spain
Centro Medico Austral OMI

Ciudad Autónoma Buenos Aires, Argentina
Centro de Investigación Pergamino SA

Pergamino, Argentina
Centro di Riferimento Oncologico (CRO)

Aviano, Italy
Chang Gung Memorial Hospital

Taoyuan, Taiwan
Chi Mei Hospital, Liouying

Liuying, Taiwan
Chongqing Cancer Hospital

Chongqing, China
Chris O'Brien Lifehouse

Camperdown, Australia
Chungbuk National University Hospital

Cheonju, South Korea
Clinica Viedma S.A

Viedma, Argentina
Clínica Universidad de Navarra

Madrid, Spain
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Diabaid

Ciudad Autónoma Buenos Aires, Argentina
Fujian Cancer Hospital

Fuzhou, China
Fundacion CENIT Para La Investigacion en Neurociencias

Ciudad Autónoma Buenos Aires, Argentina
Fundacion Respirar - Consultorios Medicos Dr. Doreski

Cabildo, Argentina
Fundación Arturo López Pérez

Providencia, Chile
Guangxi Medical University Cancer Hospital

Nanning, China
H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States
HIA Begin

Saint-Mandé, France
Hainan General Hospital

Haikou, China
Harbin Medical University Cancer Hospital

Harbin, China
Henan Cancer Hospital

Henan, China
Hospices Civils de Lyon - Hôpital Louis Pradel

Bron, France
Hospital Kuala Lumpur

Kuala Lumpur, Malaysia
Hospital La Fe

Valencia, Spain
Hospital Regional Universitario de Malaga

Málaga, Spain
Hospital Sultan Ismail

Johor Bahru, Malaysia
Hospital Universitari Vall d'Hebrón

Barcelona, 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 Universitario Virgen Macarena

Seville, Spain
Hospital Universitario Virgen de Valme

Seville, Spain
Hospital de Jeréz

Jerez de la Frontera, Spain
Hospital de la Santa Creu i Sant Pau

Barcelona, Spain
Hubei Cancer Hospital

Wuhan, China
Hunan Cancer Hospital

Changsha, China
Hôpital de La Timone AP-Hm

Marseille, France
ICO (Institut Catala d'Oncologia) Badalona - Hospital Germans Trias i Pujol

Barcelona, Spain
Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States
Innovative Clinical Research Institute, LLC

Whittier, California, 90603-2137, United States
Institut Català d'Oncología de Girona - Hospital Universitari de Girona Dr. Josep Trueta

Girona, Spain
Institut Gustave ROUSSY

Villejuif, France
Institut de Cancérologie de l'Ouest

Saint-Herblain, France
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
Istituti Fisioterapici Ospitalieri

Roma, Italy
Istituto Europeo di Oncologia

Milan, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS

Meldola, Italy
James Lind Centro De Investigacion Del Cancer

Temuco, Chile
Jilin Cancer Hospital

Changchun, China
Jinan Central Hospital

Jinan, China
Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016, United States
Linear Cancer trials

Perth, Australia
Linyi Cancer Hospital

Linyi, China
Michigan Center of Medical Research

Farmington Hills, Michigan, 48334, United States
National Cancer Center

Goyang, South Korea
National Cheng Kung University Hospital

Tainan, Taiwan
National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan
National Taiwan University Hospital

Taipei, Taiwan
Niigata University Medical & Dental Hospital

Niigata, Japan
Northwell Health - Centers for Advanced Medicine

New Hyde Park, New York, 11042-1118, United States
Okayama University Hospital

Okayama, Japan
Orlandi Oncología - Centro Médico Health & Care

Santiago, Chile
Peking Union Medical College Hospital

Beijing, China
Peter MacCallum Cancer Centre - East Melbourne

North Melbourne, Australia
Princess Margaret Cancer Centre

Toronto, Canada
SAGA

Santiago, Chile
Seoul National University Bundang Hospital

Seongnam, South Korea
Seoul National University Hospital

Seoul, South Korea
Shanxi Cancer Hospital

Taiyuan, China
Southern Medical Day Care Centre

Wollongong, Australia
St George Hospital

Kogarah, Australia
Taichung Veterans General Hospital

Taichung, Taiwan
Taipei Veterans General Hospital

Taipei, Taiwan
Taizhou Hospital of Zhejiang Province

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

Suwon, South Korea
The First Affilated Hospital of Zhejiang University

Hangzhou, China
The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China
The First Affiliated Hospital of Nanchang University

Nanchang, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China
The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China
The First Hospital of China Medical University

Shenyang, China
The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States
The Second Affiliated Hospital of Nanchang University

Nanchang, China
The Second Hospital of Anhui Medical University

Hefei, China
The first Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, China
Tianjin Medical University Cancer Institute & Hospital

Tianjin, China
Tokushima University Hospital

Tokushima, Japan
Tokyo Shinagawa Hospital

Tokyo, Japan
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China
University Malaya Medical Centre

Kuala Lumpur, Malaysia
University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States
University of California, San Diego (UCSD) - Moores Cancer Center

La Jolla, California, 92093, United States
University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States
Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States
Wan Fang Hospital

Taipei, Taiwan
West China Hospital of Sichuan University

Chengdu, China
Zhejiang Cancer Hospital

Hangzhou, China
Zhongshan Hospital, Fudan University

Shanghai, China

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