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
PYRAMID-1
A Phase 3, Randomized, Open-label, Multicenter Study of the Efficacy and Safety of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a HER2 Exon 20 Mutation Who Progressed on or After Treatment With Platinum Based Chemotherapy
1 other identifier
interventional
151
13 countries
102
Brief Summary
This is a randomized, positive-controlled, open-label, international multicenter, Phase 3 clinical study to compare the efficacy and safety of pyrotinib versus docetaxel in patients with advanced non-squamous NSCLC harboring a HER2 exon 20 mutation who failed platinum based chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2020
Typical duration for phase_3
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedStudy Start
First participant enrolled
September 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2024
CompletedDecember 19, 2025
December 1, 2025
2.7 years
June 23, 2020
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
Time from the date of randomization to the date of first disease progression documented by BIRC according to the RECIST v1.1 or death for any cause, whichever comes first.
26 months
Secondary Outcomes (10)
Overall survival (OS)
36 months
Objective response rate (ORR)
26 months
Disease control rate (DCR)
26 months
Duration of response (DoR)
26 months
Time to tumor progression (TTP)
26 months
- +5 more secondary outcomes
Study Arms (2)
Study treatment Arm
EXPERIMENTALPyrotinib maleate tablet, 400 mg, once daily (QD)
Control Arm
ACTIVE COMPARATORDocetaxel injection, 75 mg/m2, once every 3 weeks (Q3W)
Interventions
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.
75 mg/m2, once every 3 weeks (Q3W), will be administered by intravenous infusion over 1 hour, with 21 days as a cycle.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (102)
University of California - Irvine Medical Center
Orange, California, 92868, United States
University of California (UC) Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Innovative Clinical Research Institute
Whittier, California, 33756, United States
Florida Cancer Specialists South Divisio
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists North Divisio
St. Petersburg, Florida, 33701, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, 66160, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Tennessee Oncology
Nashville, Tennessee, 33756, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Summit Cancer Centers - North Spokane
Spokane, Washington, 99208, 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, 200433, 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)
Trakya University Medical Faculty
Center, 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)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wei Shi, MD,PhD
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- In this study, the Blinded Independent Review Committee (BIRC) will perform a blinded evaluation on the primary endpoint.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2020
First Posted
June 25, 2020
Study Start
September 11, 2020
Primary Completion
June 2, 2023
Study Completion
December 6, 2024
Last Updated
December 19, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share