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New pill could outperform chemo for rare lung cancer mutation

NCT ID NCT04447118

Disease control Sponsor: Jiangsu HengRui Medicine Co., Ltd. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested a targeted cancer pill called pyrotinib against standard chemotherapy (docetaxel) in 151 people with advanced non-squamous non-small cell lung cancer that has a specific HER2 mutation. All participants had already tried platinum-based chemo without success. The study measured how long the cancer stayed under control and overall survival.

What this could mean

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

Active substance
Pyrotinib (a targeted cancer pill) compared to docetaxel (a standard chemotherapy drug)
What this could lead to
If pyrotinib works better than docetaxel, it could offer a new, more effective treatment option for people with this specific type of lung cancer.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely known. Pyrotinib may not prove superior to docetaxel, and both drugs have side effects.

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

151 people

The number who actually took part.

Started

Sep 2020

Finished

Dec 2024

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: * Signed and dated written informed consent which is approved by IRB/EC, willing and able to comply with scheduled treatment, all examinations at study visits, and other study procedures. * ECOG PS 0-1. * Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC disease. * Before enrollment, a documented confirmed presence of activating mutations in exon 20 of the HER2 gene must be provided. Sufficient tumor tissue samples should be provided to retrospectively confirm the mutation status of the HER2 gene. * Must have measureable disease per RECIST v1.1. * For advanced NSCLC, patients must have had progressive disease on or after a platinum based chemotherapy, with or without immune checkpoint inhibitors (PD-1/PD-L1 inhibitors) and/or anti-angiogenic drugs. No more than 2 prior lines of systemic therapy are allowed. * The laboratory test values must meet the following standards to manifest that the functional level of important organs/systems meets the requirements. * Female patient of childbearing potential (WOCBP) and male patient whose - partner is WOCBP must agree to use effective contraception method during the study period. Exclusion Criteria: * Malignant tumors with other pathological types. * Medical history of other active malignancies within last 5 years. * Subjects with active CNS metastases. * Previously treated with targeted drugs for HER2 gene mutations,or previously treated with docetaxel. * Prior to the first dose of study treatment, patients with severe effusions with clinical symptoms, severe cardiac disease, or severe infection. * Prior to the first dose of study treatment, patients with diseases or special conditions that affect drug administration and absorption. * Congenital or acquired immunodeficiency. * History of allergy to the study drugs or components. * Prior to the first dose of study treatment, or during the study period, patients receive or are anticipated to receive continuous strong CYP3A4 inducers or inhibitors, P-gp inhibitors, or medications that are known to cause QT/QTc prolongation.

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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.

HER2 exon 20 mutation Non-squamous NSCLC

Contacts and locations

Locations

  • AP-HM - Hôpital Nord

    Marseille, France

  • ASST dei Sette Laghi-Ospedale di Circolo e Fondazione Macchi di Varese

    Varese, Italy

  • Ajou University Hospital

    Gyeonggi-do, South Korea

  • Ankara Sehir Hastanesi

    Ankara, Turkey (Türkiye)

  • Antwerp University Hospital (UZA)

    Edegem, Belgium

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, Russia

  • Asan Medical Center

    Seoul, South Korea

  • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico

    Catania, Italy

  • Baskent University Adana Application and Research Center

    Adana, Turkey (Türkiye)

  • Border Medical Oncology

    Albury, Australia

  • CHRU Strasbourg

    Strasbourg, France

  • CHU Toulouse - Hopital Larrey

    Toulouse, France

  • Calvary North Adelaide Hospital

    North Adelaide, Australia

  • Cangzhou Hospital of Integrated Tcm-Wm.Hebei

    Cangzhou, Hebei, China

  • Centre Francois Baclesse

    Caen, France

  • Centre Hospitalier Intercommunal Creteil

    Créteil, France

  • Centro Riferimento Oncologico - Aviano

    Aviano, Italy

  • Centrum Onkologii KOMED

    Konin, Poland

  • China Medical University Hospital

    Taichung, Taiwan

  • Clinical hospital RZD-Medicine of St. Petersburg

    Saint Petersburg, Russia

  • Complejo Hospitalario de Navarra

    Pamplona, Spain

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Eurocityclinic LLC

    Saint Petersburg, Russia

  • First Affiliated Hospital of ZhengzhouUniversity

    Zhengzhou, Henan, China

  • Florida Cancer Specialists North Divisio

    St. Petersburg, Florida, 33701, United States

  • Florida Cancer Specialists South Divisio

    Fort Myers, Florida, 33901, United States

  • Fudan University Cancer hospital

    Shanghai, Shanghai Municipality, China

  • Gabrail Cancer Center

    Canton, Ohio, 44718, United States

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, China

  • Gulhane Training and Research Hospital

    Keçiören, Turkey (Türkiye)

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Hopital Bichat - Claude Bernard - AP-HP

    Paris, France

  • Hospital Clinic Barcelona

    Barcelona, Spain

  • Hospital Fundación Jiménez Díaz

    Madrid, Spain

  • Hospital Germans Trias i Pujol

    Barcelona, Badalona, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Badalona, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hubei cancer hospital WardII

    Wuhan, Hubei, China

  • Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

    Changsha, Hunan, China

  • Innovative Clinical Research Institute

    Whittier, California, 33756, United States

  • Instituto Valenciano de Oncologia

    Valencia, Spain

  • Instytut Genetyki i Immunologii GENIM

    Lublin, Poland

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, Turkey (Türkiye)

  • Istituto Europeo di Oncologia

    Milan, Italy

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola (FC), Italy

  • Izmir Medical Park Hospital

    Izmir, Turkey (Türkiye)

  • JSC Group of companies Medsi

    Moscow, Russia

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, China

  • Jilin Cancer Hospital

    Changchun, Jilin, China

  • Klinikverbund Kempten-Oberallgäu gGmbH

    Kempten, Germany

  • Korea University Anam Hospital

    Seoul, South Korea

  • Linkou Chang Gung Memorial Hospital (CGMHLK)

    Taoyuan City, Taiwan

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Med Polonia Sp. z o.o.

    Poznan, Poland

  • Necmettin Erbakan University Selcuklu Faculty of Medicine

    Konya, Turkey (Türkiye)

  • POIS Leipzig GbR

    Leipzig, Germany

  • Peking university Cancer Hospital

    Beijing, Beijing Municipality, China

  • Petrov National Medical Research Center of Oncology

    Saint Petersburg, Sankt-Peterburg, Russia

  • Pius-Hospital Oldenburg, Centre of Radiotherapy and Medical Oncology, Dept. Medical Oncology

    Oldenburg, Germany

  • Royal North Shore Hospital

    St Leonards, Saint Leonards, Australia

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)

    Saint Petersburg, Russia

  • Salve-Medica

    Lodz, Poland

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seoul, Bundang, South Korea

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

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Shandong Cancer Hospital Affiliated to Shandong University

    Jinan, Shandong, China

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, China

  • Shanghai Pulmonary Hospital, Tongji University

    Shanghai, Shanghai Municipality, 200433, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, China

  • SiChuan Cancer Hospital

    Chengdu, Sichuan, China

  • Sir Charles Gairdner Hospital

    Nedlands, Australia

  • Sir Run Run Shaw Hospital ZheJiang University School Of Medicine

    Hangzhou, Zhejiang, China

  • St Vincent's Hospital Melbourne

    Fitzroy, Australia

  • Subei People's Hospital of Jiangsu Province

    Yangzhou, Jiangsu, China

  • Summit Cancer Centers - North Spokane

    Spokane, Washington, 99208, United States

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, China

  • Tennessee Oncology

    Nashville, Tennessee, 33756, United States

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital，ZheJiang University

    Hangzhou, Zhejiang, China

  • The Second Affiliated of Nanchang University

    Nanchang, Jiangxi, China

  • The Second People's Hosipital of Yibin

    Yibin, Sichuan, China

  • The affiliated hospital of inner mongolia medical univerity

    Hohhot, Neimenggu, China

  • The second affiliated hospital of ChongQing medical university

    Chongqing, Chongqing Municipality, China

  • Trakya University Medical Faculty

    Center, Turkey (Türkiye)

  • Uniklinikum Giessen und Marburg

    Giessen, Germany

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, Germany

  • University Hospital (UZ) Leuven

    Leuven, Belgium

  • University Hospital Gent

    Ghent, Belgium

  • University of California (UC) Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of California - Irvine Medical Center

    Orange, California, 92868, United States

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160, United States

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, China

  • Yunnan Provincial Cancer Hospital

    Kunming, Yunnan, China

  • ZheJiang Cancer Hospital

    Hangzhou, Zhejiang, China

  • beijing chest hospital,Capital medical university

    Beijing, Beijing Municipality, China

  • the Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

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