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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04447118




Registration number
NCT04447118
Ethics application status
Date submitted
23/06/2020
Date registered
25/06/2020

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
HR-BLTN-III-NSCLC
Universal Trial Number (UTN)
Trial acronym
PYRAMID-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-squamous NSCLC 0 0
HER2 Exon 20 Mutation 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pyrotinib
Treatment: Drugs - Docetaxel

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)


Treatment: Drugs: 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.

Treatment: Drugs: Docetaxel
75 mg/m2, once every 3 weeks (Q3W), will be administered by intravenous infusion over 1 hour, with 21 days as a cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
26 months
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
26 months
Secondary outcome [3] 0 0
Disease control rate (DCR)
Timepoint [3] 0 0
26 months
Secondary outcome [4] 0 0
Duration of response (DoR)
Timepoint [4] 0 0
26 months
Secondary outcome [5] 0 0
Time to tumor progression (TTP)
Timepoint [5] 0 0
26 months
Secondary outcome [6] 0 0
Progression-free survival 2(PFS2)
Timepoint [6] 0 0
36 months
Secondary outcome [7] 0 0
Patient reported outcome (PRO) using EORTC QLQ-C30
Timepoint [7] 0 0
26 months
Secondary outcome [8] 0 0
Patient reported outcomes (PRO) using the QLQ-LC13
Timepoint [8] 0 0
26 months
Secondary outcome [9] 0 0
Plasma concentrations of pyrotinib
Timepoint [9] 0 0
26 months
Secondary outcome [10] 0 0
AEs and SAEs
Timepoint [10] 0 0
26 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
Saint Leonard
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
Border Medical Oncology - Albury
Recruitment hospital [3] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [5] 0 0
Calvary North Adelaide Hospital - North Adelaide
Recruitment postcode(s) [1] 0 0
- St Leonards
Recruitment postcode(s) [2] 0 0
- Albury
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment postcode(s) [5] 0 0
- North Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Belgium
State/province [9] 0 0
Edegem
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
China
State/province [12] 0 0
Anhui
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Chongqing
Country [15] 0 0
China
State/province [15] 0 0
Guangdong
Country [16] 0 0
China
State/province [16] 0 0
Hebei
Country [17] 0 0
China
State/province [17] 0 0
Heilongjiang
Country [18] 0 0
China
State/province [18] 0 0
Henan
Country [19] 0 0
China
State/province [19] 0 0
Hubei
Country [20] 0 0
China
State/province [20] 0 0
Hunan
Country [21] 0 0
China
State/province [21] 0 0
Jiangsu
Country [22] 0 0
China
State/province [22] 0 0
Jiangxi
Country [23] 0 0
China
State/province [23] 0 0
Jilin
Country [24] 0 0
China
State/province [24] 0 0
Neimenggu
Country [25] 0 0
China
State/province [25] 0 0
Shandong
Country [26] 0 0
China
State/province [26] 0 0
Shanghai
Country [27] 0 0
China
State/province [27] 0 0
Shanxi
Country [28] 0 0
China
State/province [28] 0 0
Sichuan
Country [29] 0 0
China
State/province [29] 0 0
Tianjin
Country [30] 0 0
China
State/province [30] 0 0
Yunnan
Country [31] 0 0
China
State/province [31] 0 0
Zhejiang
Country [32] 0 0
France
State/province [32] 0 0
CAEN cedex 05
Country [33] 0 0
France
State/province [33] 0 0
Creteil
Country [34] 0 0
France
State/province [34] 0 0
Marseille cedex 20
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
France
State/province [36] 0 0
Strasbourg Cedex
Country [37] 0 0
France
State/province [37] 0 0
Toulouse
Country [38] 0 0
Germany
State/province [38] 0 0
Dresden
Country [39] 0 0
Germany
State/province [39] 0 0
Giessen
Country [40] 0 0
Germany
State/province [40] 0 0
Kempten
Country [41] 0 0
Germany
State/province [41] 0 0
Leipzig
Country [42] 0 0
Germany
State/province [42] 0 0
Oldenburg
Country [43] 0 0
Italy
State/province [43] 0 0
Aviano
Country [44] 0 0
Italy
State/province [44] 0 0
Catania
Country [45] 0 0
Italy
State/province [45] 0 0
Meldola (fc)
Country [46] 0 0
Italy
State/province [46] 0 0
Milano
Country [47] 0 0
Italy
State/province [47] 0 0
Varese
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Bundang
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Gyeonggi-do
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Seoul
Country [51] 0 0
Poland
State/province [51] 0 0
Konin
Country [52] 0 0
Poland
State/province [52] 0 0
Lodz
Country [53] 0 0
Poland
State/province [53] 0 0
Lublin
Country [54] 0 0
Poland
State/province [54] 0 0
Poznan
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Saint Petersburg
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Arkhangelsk
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Moscow
Country [58] 0 0
Spain
State/province [58] 0 0
Badalona
Country [59] 0 0
Spain
State/province [59] 0 0
Barcelona
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Malaga
Country [62] 0 0
Spain
State/province [62] 0 0
Pamplona
Country [63] 0 0
Spain
State/province [63] 0 0
Sevilla
Country [64] 0 0
Spain
State/province [64] 0 0
Valencia
Country [65] 0 0
Taiwan
State/province [65] 0 0
Taichung
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taipei
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taoyuan City
Country [68] 0 0
Turkey
State/province [68] 0 0
Adana
Country [69] 0 0
Turkey
State/province [69] 0 0
Ankara
Country [70] 0 0
Turkey
State/province [70] 0 0
Istanbul
Country [71] 0 0
Turkey
State/province [71] 0 0
Izmir
Country [72] 0 0
Turkey
State/province [72] 0 0
Keçiören
Country [73] 0 0
Turkey
State/province [73] 0 0
Konya
Country [74] 0 0
Turkey
State/province [74] 0 0
Merkez

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Jiangsu HengRui Medicine Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Wei Shi, MD,PhD
Address 0 0
Jiangsu Hengrui Pharmaceuticals Co.,Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04447118