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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE
PYRAMID-1

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

Rekrutierend

NCT-Nummer:
NCT04447118

Studienbeginn:
September 2020

Letztes Update:
25.03.2021

Wirkstoff:
Pyrotinib, Docetaxel

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Jiangsu HengRui Medicine Co., Ltd.

Collaborator:
-

Studienleiter

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

Kontakt

Studienlocations
(3 von 54)

Lungenklinik Hemer
Hedersleben
(Sachsen-Anhalt)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik Haematologie/Onkologie
Maintal
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikverbund Kempten-Oberallgäu gGmbH
Kempten
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
POIS Leipzig GbR
Leipzig
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Pius-Hospital Oldenburg, Centre of Radiotherapy and Medical Oncology, Dept. Medical Oncology
Oldenburg
(Niedersachsen)
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
United StatesRekrutierend» Google-Maps
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
10021 New York
United StatesRekrutierend» Google-Maps
MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Summit Cancer Centers - North Spokane
99208 Spokane
United StatesRekrutierend» Google-Maps
Royal North Shore Hospital
St Leonards
AustraliaNoch nicht rekrutierend» Google-Maps
Sir Charles Gairdner Hospital
Nedlands
AustraliaNoch nicht rekrutierend» Google-Maps
Calvary North Adelaide Hospital
North Adelaide
AustraliaRekrutierend» Google-Maps
Antwerp University Hospital (UZA)
Edegem
BelgiumNoch nicht rekrutierend» Google-Maps
University Hospital (UZ) Leuven
Leuven
BelgiumNoch nicht rekrutierend» Google-Maps
Shanghai Pulmonary Hospital, Tongji University
200433 Shanghai
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Caicun Zhou, MD,PhD
Phone: 86-021-65115006
Phone (ext.): 3050
E-Mail: caicunzhoudr@163.com
» Ansprechpartner anzeigen
Centre Hospitalier Intercommunal Creteil
Creteil
FranceRekrutierend» Google-Maps
AP-HM - Hôpital Nord
Marseille cedex 20
FranceNoch nicht rekrutierend» Google-Maps
CHRU Strasbourg
Strasbourg Cedex
FranceNoch nicht rekrutierend» Google-Maps
Centro Riferimento Oncologico - Aviano
Aviano
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
Catania
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Europeo di Oncologia
Milano
ItalyNoch nicht rekrutierend» Google-Maps
Seoul National University Bundang Hospital
Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Asan Medical Center
Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Korea University Anam Hospital
Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Samsung Medical Center
Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
Seoul
Korea, Republic ofRekrutierend» Google-Maps
Petrov National Medical Research Center of Oncology
St. Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk
Russian FederationNoch nicht rekrutierend» Google-Maps
Clinical hospital RZD-Medicine of St. Petersburg
Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Eurocityclinic LLC
Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Hospital Universitario Vall d'Hebron
Barcelona
SpainRekrutierend» Google-Maps
Hospital Fundación Jiménez Díaz
Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Regional Universitario de Malaga
Malaga
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
Sevilla
SpainNoch nicht rekrutierend» Google-Maps
Linkou Chang Gung Memorial Hospital (CGMHLK)
Taoyuan City
TaiwanRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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.

Studien-Rationale

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

Studien-Arme

  • 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.

Quelle: ClinicalTrials.gov


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