Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04447118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-08
First Post:
2020-06-23
Brief 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
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PYRAMID-1
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
Detailed Description:
150 eligible subjects will be randomized in a 21 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 mgd QD oral pyrotinib will be administered within 30 minutes after completion of a meal
Treatment regimen of docetaxel Control Arm 75 mgm2 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
Each treatment cycle is defined as 21 days for subjects in both arms Treatment regimen of pyrotinib Study treatment Arm 400 mgd QD oral pyrotinib will be administered within 30 minutes after completion of a meal
Treatment regimen of docetaxel Control Arm 75 mgm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None