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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04447118
Registration number
NCT04447118
Ethics application status
Date submitted
23/06/2020
Date registered
25/06/2020
Date last updated
8/03/2023
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
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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
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Secondary ID [1]
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HR-BLTN-III-NSCLC
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Universal Trial Number (UTN)
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Trial acronym
PYRAMID-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-squamous NSCLC
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HER2 Exon 20 Mutation
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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26 months
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Secondary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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Time from the date of randomization to death for any cause.
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Timepoint [1]
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36 months
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Secondary outcome [2]
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Objective response rate (ORR)
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Assessment method [2]
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Assessed by BIRC and investigator according to the RECIST v1.1.
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Timepoint [2]
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26 months
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Secondary outcome [3]
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Disease control rate (DCR)
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Assessment method [3]
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Assessed by BIRC and investigator according to the RECIST v1.1.
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Timepoint [3]
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26 months
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Secondary outcome [4]
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Duration of response (DoR)
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Assessment method [4]
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Assessed by BIRC and investigator according to the RECIST v1.1.
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Timepoint [4]
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26 months
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Secondary outcome [5]
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Time to tumor progression (TTP)
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Assessment method [5]
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Assessed by BIRC and investigator according to the RECIST v1.1.
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Timepoint [5]
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26 months
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Secondary outcome [6]
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Progression-free survival 2(PFS2)
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Assessment method [6]
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Assessed by investigator according to the RECIST v1.1, or death for any cause, whichever comes first.
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Timepoint [6]
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36 months
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Secondary outcome [7]
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Patient reported outcome (PRO) using EORTC QLQ-C30
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Assessment method [7]
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Symptoms related to NSCLC,
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Timepoint [7]
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26 months
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Secondary outcome [8]
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Patient reported outcomes (PRO) using the QLQ-LC13
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Assessment method [8]
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Symptoms related to NSCLC
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Timepoint [8]
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26 months
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Secondary outcome [9]
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Plasma concentrations of pyrotinib
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Assessment method [9]
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Pharmacokinetics (PK) of pyrotinib
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Timepoint [9]
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26 months
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Secondary outcome [10]
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AEs and SAEs
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Assessment method [10]
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Judged in accordance with NCI-CTCAE v5.0
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Timepoint [10]
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26 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/10/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
151
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Recruitment in Australia
Recruitment state(s)
Saint Leonard
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Recruitment hospital [1]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [2]
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Border Medical Oncology - Albury
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St Vincent's Hospital Melbourne - Fitzroy
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [5]
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Calvary North Adelaide Hospital - North Adelaide
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- St Leonards
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Recruitment postcode(s) [2]
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- Albury
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Recruitment postcode(s) [3]
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- Fitzroy
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Recruitment postcode(s) [4]
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- Nedlands
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Recruitment postcode(s) [5]
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- North Adelaide
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Recruitment outside Australia
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United States of America
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California
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Florida
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Kansas
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New York
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Ohio
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Tennessee
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Belgium
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Edegem
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Gent
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Leuven
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China
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Anhui
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China
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Beijing
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China
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Chongqing
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China
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Guangdong
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Henan
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China
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China
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Jiangsu
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China
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Jiangxi
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Jilin
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Neimenggu
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Valencia
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Merkez
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Jiangsu HengRui Medicine Co., Ltd.
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04447118
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Wei Shi, MD,PhD
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Address
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Jiangsu Hengrui Pharmaceuticals Co.,Ltd
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04447118
Download to PDF