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)

October 18, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

150 eligible subjects will be randomized in a 2:1 ratio (Study treatment Arm: Control Arm = 100 : 50 subjects) to receive pyrotinib or docetaxel monotherapy.

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).

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Albury, Australia
        • Recruiting
        • Border Medical Oncology
        • Principal Investigator:
          • Craig Underhill
      • Fitzroy, Australia
        • Recruiting
        • St Vincent's Hospital Melbourne
      • Nedlands, Australia
        • Recruiting
        • Sir Charles Gairdner Hospital
        • Principal Investigator:
          • Kevin Jasas
      • North Adelaide, Australia
        • Recruiting
        • Calvary North Adelaide Hospital
    • Saint Leonards
      • St Leonards, Saint Leonards, Australia
        • Recruiting
        • Royal North Shore Hospital
        • Principal Investigator:
          • Nick Pavlakis
  • Belgium
      • Edegem, Belgium
        • Recruiting
        • Antwerp University Hospital (UZA)
        • Principal Investigator:
          • Charlotte De Bondt
      • Gent, Belgium
        • Recruiting
        • University Hospital Gent
        • Principal Investigator:
          • Veerle Surmont
      • Leuven, Belgium
        • Recruiting
        • University Hospital (UZ) Leuven
        • Principal Investigator:
          • christophe Dooms
  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The Second Affiliated Hospital of Anhui Medical University
        • Principal Investigator:
          • Hui Zhao
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking University Cancer Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Chest Hospital,Capital Medical University
        • Principal Investigator:
          • Baolan Li
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Principal Investigator:
          • Daoxin Wang
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
        • Principal Investigator:
          • Ying Ding
    • Hebei
      • Cangzhou, Hebei, China
        • Recruiting
        • Cangzhou Hospital of Integrated Tcm-Wm.Hebei
        • Principal Investigator:
          • Enfen Zhao
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Baogang Liu
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China
        • Recruiting
        • First Affiliated Hospital of ZhengzhouUniversity
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei cancer hospital WardII
        • Principal Investigator:
          • Yanping Hu
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
      • Yangzhou, Jiangsu, China
        • Recruiting
        • Subei People's Hospital of Jiangsu province
        • Principal Investigator:
          • Xingxiang Xu
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The Second Affiliated of Nanchang University
        • Principal Investigator:
          • Anwen Liu
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Jilin Cancer Hospital
        • Principal Investigator:
          • Ying Cheng
    • Neimenggu
      • Hohhot, Neimenggu, China
        • Recruiting
        • The affiliated hospital of inner mongolia medical univerity
        • Principal Investigator:
          • Junzhen Gao
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital Affiliated to Shandong University
        • Principal Investigator:
          • Zhehai Wang
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital
        • Principal Investigator:
          • Tianqin Chu
      • Shanghai, Shanghai, China
        • Recruiting
        • Fudan University Cancer Hospital
        • Principal Investigator:
          • Jialei WANG
      • Shanghai, Shanghai, China
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Principal Investigator:
          • Min Zhou
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital, Tongji University
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Principal Investigator:
          • Xia Song
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Cancer Hospital
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital,Sichuan University
        • Principal Investigator:
          • Feng Luo
      • Yibin, Sichuan, China
        • Recruiting
        • The Second People's Hosipital of Yibin
        • Principal Investigator:
          • Yuming Jia
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • General Hospital of Tianjin Medical University
        • Principal Investigator:
          • Jun Chen
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan Provincial Cancer Hospital
        • Principal Investigator:
          • Yunchao Huang
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Principal Investigator:
          • Yun Fan
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
        • Principal Investigator:
          • Yong Fang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The first affiliated hospital,zhejiang university
        • Principal Investigator:
          • Jianying Zhou
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
  • France
      • CAEN cedex 05, France
        • Recruiting
        • Centre François Baclesse
      • Creteil, France
        • Recruiting
        • Centre Hospitalier Intercommunal Créteil
        • Principal Investigator:
          • Christos Chouaid
      • Marseille cedex 20, France
        • Recruiting
        • AP-HM - Hôpital Nord
      • Paris, France
        • Not yet recruiting
        • Hopital Bichat - Claude Bernard - AP-HP
      • Strasbourg Cedex, France
        • Not yet recruiting
        • CHRU Strasbourg
      • Toulouse, France
        • Recruiting
        • CHU Toulouse - Hopital Larrey
  • Germany
      • Dresden, Germany
        • Not yet recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden
        • Principal Investigator:
          • Martin Wermke
      • Giessen, Germany
        • Not yet recruiting
        • Uniklinikum Gießen und Marburg
        • Principal Investigator:
          • Thomas Wehler
      • Kempten, Germany
        • Not yet recruiting
        • Klinikverbund Kempten-Oberallgäu gGmbH
        • Principal Investigator:
          • Christian Schumann
      • Leipzig, Germany
        • Not yet recruiting
        • POIS Leipzig GbR
        • Principal Investigator:
          • Christian Gessner,
      • Oldenburg, Germany
        • Not yet recruiting
        • Pius-Hospital Oldenburg, Centre of Radiotherapy and Medical Oncology, Dept. Medical Oncology
        • Principal Investigator:
          • Frank Griesinger
  • Italy
      • Aviano, Italy
        • Not yet recruiting
        • Centro Riferimento Oncologico - Aviano
        • Principal Investigator:
          • Alessandra Bearz
      • Catania, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
        • Principal Investigator:
          • Hector Josè Soto Parra
      • Meldola (fc), Italy
        • Not yet recruiting
        • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
        • Sub-Investigator:
          • Angelo Delmonte
      • Milano, Italy
        • Recruiting
        • Istituto Europeo di Oncologia
        • Principal Investigator:
          • Filippo De Marinis
      • Varese, Italy
        • Not yet recruiting
        • ASST dei Sette Laghi-Ospedale di Circolo e Fondazione Macchi di Varese
        • Principal Investigator:
          • Francesco Grossi
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • Not yet recruiting
        • Ajou University Hospital
        • Principal Investigator:
          • Hyun-Woo Lee
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Dae Ho Lee
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Seoul St. Mary's Hospital, The Catholic University of Korea
        • Principal Investigator:
          • SookHee Hong
    • Bundang
      • Seoul, Bundang, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Jong-Seok Lee
  • Poland
      • Konin, Poland
        • Not yet recruiting
        • Centrum Onkologii KOMED
        • Principal Investigator:
          • Boguslawa Karaszewska
      • Lodz, Poland
        • Not yet recruiting
        • Salve-Medica
        • Principal Investigator:
          • Piotr Oczkowski
      • Lublin, Poland
        • Not yet recruiting
        • Instytut Genetyki i Immunologii GENIM
        • Principal Investigator:
          • Izabela Chmielewska
      • Poznan, Poland
        • Not yet recruiting
        • Med Polonia Sp. z o.o.
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Not yet recruiting
        • Arkhangelsk Clinical Oncological Dispensary
        • Principal Investigator:
          • Marina Nechaeva
      • Moscow, Russian Federation
        • Not yet recruiting
        • JSC Group of companies Medsi
      • Saint Petersburg, Russian Federation
        • Not yet recruiting
        • Clinical hospital RZD-Medicine of St. Petersburg
        • Principal Investigator:
          • Konstantin Penkov
      • Saint Petersburg, Russian Federation
        • Not yet recruiting
        • Eurocityclinic LLC
        • Principal Investigator:
          • Sergey Orlov
      • Saint Petersburg, Russian Federation
        • Not yet recruiting
        • Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
        • Principal Investigator:
          • Fedor Moiseenko
    • Saint Petersburg
      • St. Petersburg, Saint Petersburg, Russian Federation
        • Not yet recruiting
        • Petrov National Medical Research Center of Oncology
        • Principal Investigator:
          • Eugeniy Levchenko
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic Barcelona
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Luis Paz-Ares Rodriguez
      • Madrid, Spain
        • Recruiting
        • Hospital Fundación Jimenez Díaz
        • Principal Investigator:
          • Manuel Domine Gomez
      • Malaga, Spain
        • Recruiting
        • Hospital Regional Universitario de Málaga
        • Principal Investigator:
          • Ana Galeote
      • Pamplona, Spain
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Principal Investigator:
          • Hugo Arasanz
      • Sevilla, Spain
        • Not yet recruiting
        • Hospital Universitario Virgen Del Rocio
      • Valencia, Spain
        • Recruiting
        • Instituto Valenciano de Oncologia
        • Principal Investigator:
          • Sergio Sandiego Contreras
    • Badalona
      • Barcelona, Badalona, Spain
        • Recruiting
        • Hospital Germans Trias i Pujol
      • Barcelona, Badalona, Spain
        • Recruiting
        • Hospital Universitario Vall d'Hebron
  • Taiwan
      • Taichung, Taiwan
        • Recruiting
        • China Medical University Hospital
        • Principal Investigator:
          • Te-Chun Hsia
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Yuh-Min Chen
      • Taoyuan City, Taiwan
        • Recruiting
        • Linkou Chang Gung Memorial Hospital (CGMHLK)
        • Principal Investigator:
          • Cheng-Ta Yang
  • Turkey
      • Adana, Turkey
        • Not yet recruiting
        • Baskent University Adana Application and Research Center
        • Principal Investigator:
          • Ahmet Sezer
      • Ankara, Turkey
        • Not yet recruiting
        • Ankara Şehir Hastanesi
      • Istanbul, Turkey
        • Not yet recruiting
        • Istanbul University Cerrahpasa Medical Faculty
        • Principal Investigator:
          • Mustafa Ozguroglu
      • Izmir, Turkey
        • Not yet recruiting
        • Izmir Medical Park Hospital
      • Keçiören, Turkey
        • Not yet recruiting
        • Gulhane Training and Research Hospital
      • Konya, Turkey
        • Not yet recruiting
        • Necmettin Erbakan University Selcuklu Faculty of Medicine
        • Principal Investigator:
          • Mehmet Artac
      • Merkez, Turkey
        • Not yet recruiting
        • Trakya University Medical Faculty
  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California - Irvine Medical Center
        • Principal Investigator:
          • Viola Zhu
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California (UC) Davis Comprehensive Cancer Center
      • Whittier, California, United States, 33756
        • Recruiting
        • Innovative Clinical Research Institute
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists South Divisio
        • Contact:
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • Florida Cancer Specialists North Divisio
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center (KUMC)
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Bob Li
    • Ohio
      • Canton, Ohio, United States, 44718
        • Not yet recruiting
        • Gabrail Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 33756
        • Recruiting
        • Tennessee Oncology
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Xiuning Le
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Summit Cancer Centers - North Spokane
        • Principal Investigator:
          • Arvind Chaudhry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study treatment Arm
Pyrotinib maleate tablet, 400 mg, once daily (QD)
Drug: 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.
Other Names:
  • Irene
Active Comparator: Control Arm
Docetaxel injection, 75 mg/m2, once every 3 weeks (Q3W)
Drug: 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 Names:
  • Docetaxel injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 26 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 36 months
Time from the date of randomization to death for any cause.
36 months
Objective response rate (ORR)
Time Frame: 26 months
Assessed by BIRC and investigator according to the RECIST v1.1.
26 months
Disease control rate (DCR)
Time Frame: 26 months
Assessed by BIRC and investigator according to the RECIST v1.1.
26 months
Duration of response (DoR)
Time Frame: 26 months
Assessed by BIRC and investigator according to the RECIST v1.1.
26 months
Time to tumor progression (TTP)
Time Frame: 26 months
Assessed by BIRC and investigator according to the RECIST v1.1.
26 months
Progression-free survival 2(PFS2)
Time Frame: 36 months
Assessed by investigator according to the RECIST v1.1, or death for any cause, whichever comes first.
36 months
Patient reported outcome (PRO) using EORTC QLQ-C30
Time Frame: 26 months
Symptoms related to NSCLC,
26 months
Patient reported outcomes (PRO) using the QLQ-LC13
Time Frame: 26 months
Symptoms related to NSCLC
26 months
Plasma concentrations of pyrotinib
Time Frame: 26 months
Pharmacokinetics (PK) of pyrotinib
26 months
AEs and SAEs
Time Frame: 26 months
Judged in accordance with NCI-CTCAE v5.0
26 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Study Director: Wei Shi, MD,PhD, Jiangsu Hengrui Pharmaceuticals Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2020

Primary Completion (Anticipated)

October 31, 2022

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-BLTN-III-NSCLC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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