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 (PYRAMID-1)
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|ClinicalTrials.gov Identifier: NCT04447118|
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : March 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non-squamous NSCLC HER2 Exon 20 Mutation||Drug: Pyrotinib Drug: Docetaxel||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||In this study, the Blinded Independent Review Committee (BIRC) will perform a blinded evaluation on the primary endpoint.|
|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|
|Actual Study Start Date :||September 11, 2020|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||October 31, 2023|
Experimental: Study treatment Arm
Pyrotinib maleate tablet, 400 mg, once daily (QD)
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.
Other Name: Irene
Active Comparator: Control Arm
Docetaxel injection, 75 mg/m2, once every 3 weeks (Q3W)
75 mg/m2, once every 3 weeks (Q3W), will be administered by intravenous infusion over 1 hour, with 21 days as a cycle.
Other Name: Docetaxel injection
- 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.
- Overall survival (OS) [ Time Frame: 36 months ]Time from the date of randomization to death for any cause.
- Objective response rate (ORR) [ Time Frame: 26 months ]Assessed by BIRC and investigator according to the RECIST v1.1.
- Disease control rate (DCR) [ Time Frame: 26 months ]Assessed by BIRC and investigator according to the RECIST v1.1.
- Duration of response (DoR) [ Time Frame: 26 months ]Assessed by BIRC and investigator according to the RECIST v1.1.
- Time to tumor progression (TTP) [ Time Frame: 26 months ]Assessed by BIRC and investigator according to the RECIST v1.1.
- 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.
- Patient reported outcome (PRO) using EORTC QLQ-C30 [ Time Frame: 26 months ]Symptoms related to NSCLC,
- Patient reported outcomes (PRO) using the QLQ-LC13 [ Time Frame: 26 months ]Symptoms related to NSCLC
- Plasma concentrations of pyrotinib [ Time Frame: 26 months ]Pharmacokinetics (PK) of pyrotinib
- AEs and SAEs [ Time Frame: 26 months ]Judged in accordance with NCI-CTCAE v5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04447118
|Contact: Caixun Zhou, MD,PhD||86-021-65115006 ext email@example.com|
|Contact: Huiyu Lan||+86 firstname.lastname@example.org|
|Study Director:||Wei Shi, MD,PhD||Jiangsu HengRui Medicine Co., Ltd.|