Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy
NCT ID: NCT04447118
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
151 participants
INTERVENTIONAL
2020-09-11
2024-12-06
Brief Summary
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Detailed Description
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Each treatment cycle is defined as 21 days for subjects in both arms. Treatment regimen of pyrotinib (Study treatment Arm): 400 mg/d (QD) oral pyrotinib will be administered within 30 minutes after completion of a meal.
Treatment regimen of docetaxel (Control Arm): 75 mg/m2 (Q3W) of docetaxel will be administered via intravenous infusion.
In this study, crossover treatment is allowed for subjects in Control Arm. Within the specified time window of each cycle, subjects should complete physical examinations, laboratory tests, quality of life questionnaires and other tests to assess the safety and quality of life of the subjects.
During study treatment, tumor radiological assessments will be performed every 6 weeks (42 ± 7 days) in the first 52 weeks and every 12 weeks (84 ± 7 days) thereafter.
After the end of treatment and safety follow-up, all subjects will be followed for survival (every 56 ± 7 days) until death, withdrawal of informed consent, lost to follow-up, or termination of the study (whichever occurs first).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Study treatment Arm
Pyrotinib maleate tablet, 400 mg, once daily (QD)
Pyrotinib
400 mg, once daily (QD), will be administered with water within 30 minutes after completion of a meal, at approximately the same time each day on a continuous daily dosing schedule, with 21 days as a cycle.
Control Arm
Docetaxel injection, 75 mg/m2, once every 3 weeks (Q3W)
Docetaxel
75 mg/m2, once every 3 weeks (Q3W), will be administered by intravenous infusion over 1 hour, with 21 days as a cycle.
Interventions
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Pyrotinib
400 mg, once daily (QD), will be administered with water within 30 minutes after completion of a meal, at approximately the same time each day on a continuous daily dosing schedule, with 21 days as a cycle.
Docetaxel
75 mg/m2, once every 3 weeks (Q3W), will be administered by intravenous infusion over 1 hour, with 21 days as a cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Shi, MD,PhD
Role: STUDY_DIRECTOR
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Locations
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University of California - Irvine Medical Center
Orange, California, United States
University of California (UC) Davis Comprehensive Cancer Center
Sacramento, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Florida Cancer Specialists South Divisio
Fort Myers, Florida, United States
Florida Cancer Specialists North Divisio
St. Petersburg, Florida, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
Tennessee Oncology
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Summit Cancer Centers - North Spokane
Spokane, Washington, United States
Royal North Shore Hospital
St Leonards, Saint Leonards, Australia
Border Medical Oncology
Albury, , Australia
St Vincent's Hospital Melbourne
Fitzroy, , Australia
Sir Charles Gairdner Hospital
Nedlands, , Australia
Calvary North Adelaide Hospital
North Adelaide, , Australia
Antwerp University Hospital (UZA)
Edegem, , Belgium
University Hospital Gent
Ghent, , Belgium
University Hospital (UZ) Leuven
Leuven, , Belgium
the Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
beijing chest hospital,Capital medical university
Beijing, Beijing Municipality, China
Peking university Cancer Hospital
Beijing, Beijing Municipality, China
The second affiliated hospital of ChongQing medical university
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Cangzhou Hospital of Integrated Tcm-Wm.Hebei
Cangzhou, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
First Affiliated Hospital of ZhengzhouUniversity
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
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
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Subei People's Hospital of Jiangsu Province
Yangzhou, Jiangsu, China
The Second Affiliated of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The affiliated hospital of inner mongolia medical univerity
Hohhot, Neimenggu, China
Shandong Cancer Hospital Affiliated to Shandong University
Jinan, Shandong, China
Shanghai Pulmonary Hospital, Tongji University
Shanghai, Shanghai Municipality, China
Fudan University Cancer hospital
Shanghai, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
SiChuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
The Second People's Hosipital of Yibin
Yibin, Sichuan, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Yunnan Provincial Cancer Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital ZheJiang University School Of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital，ZheJiang University
Hangzhou, Zhejiang, China
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Centre Francois Baclesse
Caen, , France
Centre Hospitalier Intercommunal Creteil
Créteil, , France
AP-HM - Hôpital Nord
Marseille, , France
Hopital Bichat - Claude Bernard - AP-HP
Paris, , France
CHRU Strasbourg
Strasbourg, , France
CHU Toulouse - Hopital Larrey
Toulouse, , France
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Uniklinikum Giessen und Marburg
Giessen, , Germany
Klinikverbund Kempten-Oberallgäu gGmbH
Kempten, , Germany
POIS Leipzig GbR
Leipzig, , Germany
Pius-Hospital Oldenburg, Centre of Radiotherapy and Medical Oncology, Dept. Medical Oncology
Oldenburg, , Germany
Centro Riferimento Oncologico - Aviano
Aviano, , Italy
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
Catania, , Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola (FC), , Italy
Istituto Europeo di Oncologia
Milan, , Italy
ASST dei Sette Laghi-Ospedale di Circolo e Fondazione Macchi di Varese
Varese, , Italy
Centrum Onkologii KOMED
Konin, , Poland
Salve-Medica
Lodz, , Poland
Instytut Genetyki i Immunologii GENIM
Lublin, , Poland
Med Polonia Sp. z o.o.
Poznan, , Poland
Petrov National Medical Research Center of Oncology
Saint Petersburg, Sankt-Peterburg, Russia
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, , Russia
JSC Group of companies Medsi
Moscow, , Russia
Clinical hospital RZD-Medicine of St. Petersburg
Saint Petersburg, , Russia
Eurocityclinic LLC
Saint Petersburg, , Russia
Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
Saint Petersburg, , Russia
Seoul National University Bundang Hospital
Seoul, Bundang, South Korea
Ajou University Hospital
Gyeonggi-do, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Germans Trias i Pujol
Barcelona, Badalona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Badalona, Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
China Medical University Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital (CGMHLK)
Taoyuan, , Taiwan
Baskent University Adana Application and Research Center
Adana, , Turkey (Türkiye)
Ankara Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Izmir Medical Park Hospital
Izmir, , Turkey (Türkiye)
Gulhane Training and Research Hospital
Keçiören, , Turkey (Türkiye)
Necmettin Erbakan University Selcuklu Faculty of Medicine
Konya, , Turkey (Türkiye)
Trakya University Medical Faculty
Merkez, , Turkey (Türkiye)
Countries
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Other Identifiers
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HR-BLTN-III-NSCLC
Identifier Type: -
Identifier Source: org_study_id