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New pill could outperform chemo for rare lung cancer

NCT ID NCT05668988

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests a new oral drug called sunvozertinib (DZD9008) against standard chemotherapy in 324 people with advanced non-small cell lung cancer that has a specific EGFR mutation (exon20 insertion). Participants are randomly assigned to receive either the new drug or chemo. The main goal is to see if the new drug delays cancer growth better than chemo.

What this could mean

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

Active substance
sunvozertinib (DZD9008)
What this could lead to
If it works, this could offer a more effective first-line targeted treatment for people with a specific type of lung cancer, potentially delaying disease progression compared to standard chemotherapy.
What could go wrong
This is a phase 3 trial, but results are not yet available. The drug may not prove superior to chemotherapy, and side effects are possible. It only applies to patients with a rare EGFR mutation.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

324 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Oct 2027

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 (or per local regulatory/IRB requirement). 2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy. 3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation 4. At least 1 measurable lesion per RECIST Version 1.1 5. Life expectancy ≥ 12 weeks 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 7. Adequate organ and hematologic function Exclusion Criteria: 1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC. 2. Spinal cord compression or leptomeningeal metastasis. 3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q. 4. History of stroke or intracranial hemorrhage within 6 months before randomization. 5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).

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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

  • AP-HP - Hopital Cochin

    Paris, France

  • AUSL-IRCCS di Reggio Emilia

    Reggio Emilia, Italy

  • Anhui Provincial Hospital

    Hefei, China

  • Ankara Bilkent City Hospital

    Ankara, Turkey (Türkiye)

  • Aou Policlinico G. Rodolico - S. Marcoa

    Catania, Italy

  • Asklepios Klinik Gauting GmbH

    Gauting, Germany

  • Assistance Publique Hopitaux de Marseille (AP-HM) Hopital Nord

    Marseille, France

  • Assistance Publique-Hopitaux de Paris (AP-HP)- Hopital Tenon

    Paris, France

  • Ausl Della Romagna-Po Ravenna Lugo Faenza

    Ravenna, Italy

  • Azienda Ospedaliera Universitaria Senese - Ospedale Senta Maria alle

    Siena, Italy

  • Azienda Ospedaliero-Universitaria Careggi (AOUC) - SC di Oncologia MedicaI

    Florence, Italy

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, Italy

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, Italy

  • Azienda USL Toscana Sud Est -Ospedale Misericordia - Grosseto

    Grosseto, Italy

  • BRCR Medical Center Inc.

    Plantation, Florida, 33324, United States

  • Beijing Cancer Hospital

    Beijing, China

  • Beijing Chest Hospital, Capital Medical University

    Beijing, China

  • Bezmialem Vakif University

    Istanbul, Turkey (Türkiye)

  • CHU de Nantes - Saint Herblain

    Saint-Herblain, France

  • Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center

    Shenzhen, China

  • Cancer Hospital of the Chinese Academy of Medical Sciences

    Beijing, China

  • Casa di Cura di Alta Specialita - Palermo

    Palermo, Italy

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, China

  • Centre Hospitalier Intercommunal de Creteil (CHIC)

    Créteil, France

  • Centre Hospitalier Universitaire (CHU) Grenobles Alpes- Hôpital Albert Michallon

    Hellemmes-Lille, France

  • Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon

    La Tronche, France

  • Centre Hospitalier Universitaire d'Angers

    Angers, France

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, France

  • Centro Diabaid

    Buenos Aires, Argentina

  • Centro Medico Austral

    Buenos Aires, Argentina

  • Centro de Educación Médica e Investigaciones Clínicas, CEMIC

    Buenos Aires, Argentina

  • Centro de Investigación Clínicas. Clinica Viedma S.A

    Viedma, Argentina

  • Centro di Riferimento Oncologico di Aviano (CRO)-IRCCS

    Aviano, Italy

  • Cetre Hospitalier Universitaire de Poitiers

    Poitiers, France

  • Chongqing Cancer Hospital

    Chongqing, China

  • Clínica Universidad de Navarra

    Madrid, Spain

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, Spain

  • Concord Repatriation General Hospital

    Concord, Australia

  • Consultorios Medicos Dr. Doreski - Fundacion Respirar

    Buenos Aires, Argentina

  • D&H Cancer Research Center LLC

    Margate, Florida, 33054, United States

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, Turkey (Türkiye)

  • Evangelische Lungenklinik Berlin

    Berlin, Germany

  • Fakultni Nemocnice Olomouc

    Olomouc, Czechia

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Italy

  • Fujian Cancer Hospital

    Fuzhou, China

  • Fujian Medical University Union Hospital

    Fuzhou, China

  • Fundacao PIO XII - Hospital do Cancer de Barretos

    Barretos, Brazil

  • Fundacion Cenit Para El Estudio De Neurociencias

    Buenos Aires, Argentina

  • Fundación Ars Médica

    San Salvador, Argentina

  • Fundación Estudios Clínicos

    Rosario, Argentina

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718, United States

  • Gazi University Faculty of Medicine Hospital

    Ankara, Turkey (Türkiye)

  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Kadıköy, Turkey (Türkiye)

  • Grand Hopital de Charleroi

    Charleroi, Hainaut, Belgium

  • Guangxi Medical University Cancer Hospital

    Nanning, China

  • HCL - Hôpital Louis Pradel

    Bron, France

  • Harbin Medical University Cancer Hospital

    Harbin, China

  • Henan Cancer Hospital

    Zhengzhou, China

  • Hopital Foch

    Suresnes, France

  • Hopital Paris Saint Joseph

    Paris, France

  • Hopital d'Instruction Des Armees (HIA) Begin

    Saint-Mandé, France

  • Hospital Clinico Universitario de Valencia

    Valencia, Spain

  • Hospital Evangelico de Cachoeiro de Itapemirim

    Cachoeiro de Itapemirim, Brazil

  • Hospital HM Sanchinarro

    Madrid, Spain

  • Hospital Italiano de Buenos Aires (HIBA)

    Buenos Aires, Argentina

  • Hospital Regional Universitario de Málaga

    Málaga, Spain

  • Hospital Universitari Dexeus

    Barcelona, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitari i Politècnic La Fe

    Valencia, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Fundación Jiménez Diaz

    Madrid, Spain

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Spain

  • Hospital Universitario Virgen de Valme

    Seville, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hospital Universitario de Jerez

    Jerez de la Frontera, Spain

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, Spain

  • Hunan Cancer Hospital

    Changsha, China

  • Hôpital Bichat - Claude Bernard (AP-HP)

    Paris, France

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola

    Bologna, Italy

  • IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena

    Roma, Italy

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

    Barcelona, Barcelona, Spain

  • Institut Catala d'Oncologia de Girona -Hospital Universitari Dr Josep Trueta

    Girona, Spain

  • Institut de Cancerologie de L'Ouest

    Saint-Herblain, France

  • Instituto Alexander Fleming

    Buenos Aires, Argentina

  • Instituto Argentino de Diagnositco y Tratamiento S.A

    Buenos Aires, Argentina

  • Instituto D'Or de Pesquisa e Ensino

    Recife, Brazil

  • Instituto D'Or de Pesquisa e Ensino

    Rio de Janeiro, Brazil

  • Instituto Nacional de Cancer - INCA

    Rio de Janeiro, Brazil

  • Instituto de Educacao, Pesquisa d Gestao em Saude

    Rio de Janeiro, Brazil

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, Brazil

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Brazil

  • Istituto Scientifico Romagnolo per lo Studio e La Cura dei Tumori Srl (IRST)

    Meldola, Italy

  • Jiangsu Cancer Hospital

    Nanjing, China

  • Jiangsu Provincial Hospital

    Nanjing, China

  • Jilin Cancer Hospital

    Jilin City, China

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589, United States

  • Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne (UCK)

    Gdansk, Poland

  • Liga Norte Riograndense Contra o Câncer

    Natal, Brazil

  • Liv Hospital Ankara - Medical Oncology Clinic

    Ankara, Turkey (Türkiye)

  • London Regional Cancer Program London Health Sciences Centre

    London, Canada

  • MED-POLONIA Sp. z o.o.

    Poznan, Poland

  • MVZ Ⅱ der Niels Stensen Kliniken

    Georgsmarienhütte, Germany

  • NYU Laura & Issac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie

    Warsaw, Poland

  • Necmettin Erbakan University Meram Faculty of Medicine

    Konya, Turkey (Türkiye)

  • Nemocnice AGEL Ostrava-Vitkovice a.s

    Ostrava, Czechia

  • OPN Healthcare, Inc.

    Glendale, California, 91203, United States

  • OSU Brain & Spine Hospital

    Columbus, Ohio, 43210, United States

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, Austria

  • Peking Union Medical College Hospital

    Beijing, China

  • Peking University Third Hospital

    Beijing, China

  • Peter MacCallum Cancer Centre

    Melbourne, Australia

  • Prince of Wales Hospital

    Randwick, Australia

  • Princess Margaret Cancer Center- University Health Network

    Toronto, Canada

  • Providence Portland Institute Franz

    Portland, Oregon, 97213, United States

  • Shandong Cancer Hospital & Institution

    Jinan, China

  • Shanghai Chest Hospital

    Shanghai, China

  • Shanghai Pulmonary Hospital

    Shanghai, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, China

  • Sir Charles Gairdner Hospital

    Nedlands, Australia

  • Taizhou Hospital of Zhejiang Province

    Taizhou, China

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, China

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, China

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, China

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, China

  • The First Hospital of China Medical University

    Shenyang, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, China

  • The Ottawa Hospital Cancer Center

    Ottawa, Canada

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, China

  • The University of Texas MD Anderson cancer center

    Houston, Texas, 77030, United States

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, Germany

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, China

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

    Wuhan, China

  • Trakya University Health Research and Application Center Hospital

    Edirne, Turkey (Türkiye)

  • UOMI Cancer Center - Clinica Mi Tres Torres

    Barcelona, Spain

  • UZ Gent

    Ghent, Flanders, Belgium

  • Uniao Brasileira de Educacao e Assistencia - Hospital São Lucas da PUCRS

    Porto Alegre, Brazil

  • Uniklinikum Salzburg Universitatsklinik fur Innere Medizin Ⅲ

    Salzburg, Austria

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

    Wuhan, China

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik und Poliklinik

    Mainz, Germany

  • Universitair Ziekenhuis Antwerpen

    Edegem, Antwerp, Belgium

  • Universitatsklinik Innere Medizin-Onkologie

    Oldenburg, Germany

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045, United States

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22908, United States

  • West China Hospital of Sichuan University

    Chengdu, China

  • Wojewódzki Szpital im. św. Ojca Pio

    Przemyśl, Poland

  • Yantai Yuhuangding Hospital

    Yantai, China

  • Yunnan Cancer Hospital

    Kunming, China

  • Zhejiang Cancer Hospital

    Hangzhou, China

  • ZhongShan Hospital Fudan University

    Shanghai, China

  • exas Oncology--McAllen

    Weslaco, Texas, 78596, United States

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Other studies related to the condition(s) this trial covers.