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Imfinzi NSCLC
Imfinzi NSCLC

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



September 2020

Letztes Update:

Pyrotinib, Docetaxel

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung


Erwachsene (18+)

Phase 3

Jiangsu HengRui Medicine Co., Ltd.



Wei Shi, MD,PhD
Study Director
Jiangsu HengRui Medicine Co., Ltd.


(3 von 54)

Lungenklinik Hemer
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik Haematologie/Onkologie
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Carl Gustav Carus Dresden
GermanyNoch nicht rekrutierend» Google-Maps
Klinikverbund Kempten-Oberallgäu gGmbH
GermanyNoch nicht rekrutierend» Google-Maps
POIS Leipzig GbR
GermanyNoch nicht rekrutierend» Google-Maps
Pius-Hospital Oldenburg, Centre of Radiotherapy and Medical Oncology, Dept. Medical Oncology
GermanyNoch nicht rekrutierend» Google-Maps
University of California - Irvine Medical Center
92868 Orange
United StatesRekrutierend» Google-Maps
University of California (UC) Davis Comprehensive Cancer Center
95817 Sacramento
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David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
10021 New York
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MD Anderson Cancer Center
77030 Houston
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Summit Cancer Centers - North Spokane
99208 Spokane
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Royal North Shore Hospital
St Leonards
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Sir Charles Gairdner Hospital
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Calvary North Adelaide Hospital
North Adelaide
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Antwerp University Hospital (UZA)
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University Hospital (UZ) Leuven
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Shanghai Pulmonary Hospital, Tongji University
200433 Shanghai
ChinaRekrutierend» Google-Maps
Caicun Zhou, MD,PhD
Phone: 86-021-65115006
Phone (ext.): 3050
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Centre Hospitalier Intercommunal Creteil
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AP-HM - Hôpital Nord
Marseille cedex 20
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CHRU Strasbourg
Strasbourg Cedex
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Centro Riferimento Oncologico - Aviano
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Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
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Istituto Europeo di Oncologia
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Seoul National University Bundang Hospital
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Asan Medical Center
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Korea University Anam Hospital
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Samsung Medical Center
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
Korea, Republic ofRekrutierend» Google-Maps
Petrov National Medical Research Center of Oncology
St. Petersburg
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Arkhangelsk Clinical Oncological Dispensary
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Clinical hospital RZD-Medicine of St. Petersburg
Saint Petersburg
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Eurocityclinic LLC
Saint Petersburg
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Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
Saint Petersburg
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Hospital Universitario Vall d'Hebron
SpainRekrutierend» Google-Maps
Hospital Fundación Jiménez Díaz
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Hospital Regional Universitario de Malaga
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Hospital Universitario Virgen del Rocio
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Linkou Chang Gung Memorial Hospital (CGMHLK)
Taoyuan City
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Alle anzeigen


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).


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.


Primary outcome:

1. 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.

Secondary outcome:

1. Overall survival (OS) (Time Frame - 36 months):
Time from the date of randomization to death for any cause.

2. Objective response rate (ORR) (Time Frame - 26 months):
Assessed by BIRC and investigator according to the RECIST v1.1.

3. Disease control rate (DCR) (Time Frame - 26 months):
Assessed by BIRC and investigator according to the RECIST v1.1.

4. Duration of response (DoR) (Time Frame - 26 months):
Assessed by BIRC and investigator according to the RECIST v1.1.

5. Time to tumor progression (TTP) (Time Frame - 26 months):
Assessed by BIRC and investigator according to the RECIST v1.1.

6. 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.

7. Patient reported outcome (PRO) using EORTC QLQ-C30 (Time Frame - 26 months):
Symptoms related to NSCLC,

8. Patient reported outcomes (PRO) using the QLQ-LC13 (Time Frame - 26 months):
Symptoms related to NSCLC

9. Plasma concentrations of pyrotinib (Time Frame - 26 months):
Pharmacokinetics (PK) of pyrotinib

10. AEs and SAEs (Time Frame - 26 months):
Judged in accordance with NCI-CTCAE v5.0


  • Experimental: Study treatment Arm
    Pyrotinib maleate tablet, 400 mg, once daily (QD)
  • Active Comparator: Control Arm
    Docetaxel injection, 75 mg/m2, once every 3 weeks (Q3W)

Geprüfte Regime

  • Pyrotinib (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.
  • Docetaxel (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.


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