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Non-squamous NSCLCPhase 3PYRAMID-1NCT04447118

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

A Phase 3 study testing Pyrotinib and Docetaxel in people with Non-squamous NSCLC and HER2 Exon 20 Mutation, run by Jiangsu HengRui Medicine Co., Ltd. at 102 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-squamous NSCLC, HER2 Exon 20 Mutation
What is being tested?
Pyrotinib and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
102 sitesin 13 countries
Study dates
11 Sep 2020to 6 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

102 sites in 13 countries.

102 sites in 13 countries

China31 sites

  • beijing chest hospital,Capital medical university

    Beijing, Beijing Municipality

  • Peking university Cancer Hospital

    Beijing, Beijing Municipality

  • Cangzhou Hospital of Integrated Tcm-Wm.Hebei

    Cangzhou, Hebei

  • Jilin Cancer Hospital

    Changchun, Jilin

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

    Changsha, Hunan

  • SiChuan Cancer Hospital

    Chengdu, Sichuan

  • West China Hospital,Sichuan University

    Chengdu, Sichuan

  • The second affiliated hospital of ChongQing medical university

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong

  • Sir Run Run Shaw Hospital ZheJiang University School Of Medicine

    Hangzhou, Zhejiang

  • The First Affiliated Hospital，ZheJiang University

    Hangzhou, Zhejiang

  • ZheJiang Cancer Hospital

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • the Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • The affiliated hospital of inner mongolia medical univerity

    Hohhot, Neimenggu

  • Shandong Cancer Hospital Affiliated to Shandong University

    Jinan, Shandong

  • Yunnan Provincial Cancer Hospital

    Kunming, Yunnan

  • The Second Affiliated of Nanchang University

    Nanchang, Jiangxi

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • Shanghai Pulmonary Hospital, Tongji University

    Shanghai, Shanghai Municipality, 200433

  • Fudan University Cancer hospital

    Shanghai, Shanghai Municipality

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality

  • Hubei cancer hospital WardII

    Wuhan, Hubei

  • Subei People's Hospital of Jiangsu Province

    Yangzhou, Jiangsu

  • The Second People's Hosipital of Yibin

    Yibin, Sichuan

  • First Affiliated Hospital of ZhengzhouUniversity

    Zhengzhou, Henan

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

United States11 sites

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Florida Cancer Specialists South Divisio

    Fort Myers, Florida, 33901

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160

  • Tennessee Oncology

    Nashville, Tennessee, 33756

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

    New York, New York, 10021

  • University of California - Irvine Medical Center

    Orange, California, 92868

  • University of California (UC) Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Summit Cancer Centers - North Spokane

    Spokane, Washington, 99208

  • Florida Cancer Specialists North Divisio

    St. Petersburg, Florida, 33701

  • Innovative Clinical Research Institute

    Whittier, California, 33756

Other trials in United States

Spain9 sites

  • Hospital Germans Trias i Pujol

    Barcelona, Badalona

  • Hospital Universitario Vall d'Hebron

    Barcelona, Badalona

  • Hospital Clinic Barcelona

    Barcelona

  • Hospital Fundación Jiménez Díaz

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Regional Universitario de Malaga

    Málaga

  • Complejo Hospitalario de Navarra

    Pamplona

  • Hospital Universitario Virgen del Rocio

    Seville

  • Instituto Valenciano de Oncologia

    Valencia

Other trials in Spain

South Korea7 sites

  • Ajou University Hospital

    Gyeonggi-do

  • Seoul National University Bundang Hospital

    Seoul, Bundang

  • Asan Medical Center

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Samsung Medical Center

    Seoul

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

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

Other trials in South Korea

Turkey (Türkiye)7 sites

  • Baskent University Adana Application and Research Center

    Adana

  • Ankara Sehir Hastanesi

    Ankara

  • Trakya University Medical Faculty

    Center

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul

  • Izmir Medical Park Hospital

    Izmir

  • Gulhane Training and Research Hospital

    Keçiören

  • Necmettin Erbakan University Selcuklu Faculty of Medicine

    Konya

Other trials in Turkey (Türkiye)

France6 sites

  • Centre Francois Baclesse

    Caen

  • Centre Hospitalier Intercommunal Creteil

    Créteil

  • AP-HM - Hôpital Nord

    Marseille

  • Hopital Bichat - Claude Bernard - AP-HP

    Paris

  • CHRU Strasbourg

    Strasbourg

  • CHU Toulouse - Hopital Larrey

    Toulouse

Other trials in France

Russia6 sites

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk

  • JSC Group of companies Medsi

    Moscow

  • Petrov National Medical Research Center of Oncology

    Saint Petersburg, Sankt-Peterburg

  • Clinical hospital RZD-Medicine of St. Petersburg

    Saint Petersburg

  • Eurocityclinic LLC

    Saint Petersburg

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

    Saint Petersburg

Other trials in Russia

Australia5 sites

  • Border Medical Oncology

    Albury

  • St Vincent's Hospital Melbourne

    Fitzroy

  • Sir Charles Gairdner Hospital

    Nedlands

  • Calvary North Adelaide Hospital

    North Adelaide

  • Royal North Shore Hospital

    St Leonards, Saint Leonards

Other trials in Australia

Germany5 sites

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden

  • Uniklinikum Giessen und Marburg

    Giessen

  • Klinikverbund Kempten-Oberallgäu gGmbH

    Kempten

  • POIS Leipzig GbR

    Leipzig

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

    Oldenburg

Other trials in Germany

Italy5 sites

  • Centro Riferimento Oncologico - Aviano

    Aviano

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

    Catania

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola (FC)

  • Istituto Europeo di Oncologia

    Milan

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

    Varese

Other trials in Italy

Poland4 sites

  • Centrum Onkologii KOMED

    Konin

  • Salve-Medica

    Lodz

  • Instytut Genetyki i Immunologii GENIM

    Lublin

  • Med Polonia Sp. z o.o.

    Poznan

Other trials in Poland

Belgium3 sites

  • Antwerp University Hospital (UZA)

    Edegem

  • University Hospital Gent

    Ghent

  • University Hospital (UZ) Leuven

    Leuven

Other trials in Belgium

Taiwan3 sites

  • China Medical University Hospital

    Taichung

  • Taipei Veterans General Hospital

    Taipei

  • Linkou Chang Gung Memorial Hospital (CGMHLK)

    Taoyuan City

Other trials in Taiwan

About this study

Official title: 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.

Read the 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).

Being tested
Pyrotinib, Docetaxel
Keywords
pyrotinib, docetaxel, HER2 Exon 20 Mutation, NSCLC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PyrotinibDrug

    Also called Irene

    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.

  • DocetaxelDrug

    Also called Docetaxel injection

    75 mg/m2, once every 3 weeks (Q3W), will be administered by intravenous infusion over 1 hour, with 21 days as a cycle.

Study groups in NCT04447118
Study groupRoleWhat they receive
Study treatment ArmExperimentalPyrotinib maleate tablet, 400 mg, once daily (QD)
Receives: Drug: Pyrotinib
Control ArmActive comparatorDocetaxel injection, 75 mg/m2, once every 3 weeks (Q3W)
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 26 months

Secondary outcomes (10)

  1. Overall survival (OS)

    Time from the date of randomization to death for any cause.

    Measured: 36 months

  2. Objective response rate (ORR)

    Assessed by BIRC and investigator according to the RECIST v1.1.

    Measured: 26 months

  3. Disease control rate (DCR)

    Assessed by BIRC and investigator according to the RECIST v1.1.

    Measured: 26 months

  4. Duration of response (DoR)

    Assessed by BIRC and investigator according to the RECIST v1.1.

    Measured: 26 months

  5. Time to tumor progression (TTP)

    Assessed by BIRC and investigator according to the RECIST v1.1.

    Measured: 26 months

  6. Progression-free survival 2(PFS2)

    Assessed by investigator according to the RECIST v1.1, or death for any cause, whichever comes first.

    Measured: 36 months

  7. Patient reported outcome (PRO) using EORTC QLQ-C30

    Symptoms related to NSCLC,

    Measured: 26 months

  8. Patient reported outcomes (PRO) using the QLQ-LC13

    Symptoms related to NSCLC

    Measured: 26 months

  9. Plasma concentrations of pyrotinib

    Pharmacokinetics (PK) of pyrotinib

    Measured: 26 months

  10. AEs and SAEs

    Judged in accordance with NCI-CTCAE v5.0

    Measured: 26 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2020
  2. Study start11 Sep 2020
  3. Primary completion2 Jun 2023
  4. Study completion6 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04447118
Sponsor's protocol ID
HR-BLTN-III-NSCLC
Acronym
PYRAMID-1
Status last verified
Dec 2025
First submitted
23 Jun 2020
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pyrotinib and Docetaxel in people with Non-squamous NSCLC and HER2 Exon 20 Mutation, run by Jiangsu HengRui Medicine Co., Ltd. at 102 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in China, United States, Spain, South Korea, Turkey (Türkiye) and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 26 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04447118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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