Your session is about to expire
← Back to Search
Mitotic Inhibitor
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 Trial)
Phase 3
Waitlist Available
Research Sponsored by Jiangsu HengRui Medicine Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing pyrotinib, an oral medication, in patients with advanced non-squamous NSCLC who have a HER2 exon 20 mutation and did not respond to previous chemotherapy. Pyrotinib aims to block proteins that help cancer cells grow. It was approved in China for HER2-positive breast cancer and has shown promising antitumor activity against HER2-mutant NSCLC.
Eligible Conditions
- Non-squamous Non-small-cell Lung Cancer
- HER2 Mutation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
AEs and SAEs
Disease control rate (DCR)
Duration of response (DoR)
+7 moreAwards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Study treatment ArmExperimental Treatment1 Intervention
Pyrotinib maleate tablet, 400 mg, once daily (QD)
Group II: Control ArmActive Control1 Intervention
Docetaxel injection, 75 mg/m2, once every 3 weeks (Q3W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pyrotinib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Jiangsu HengRui Medicine Co., Ltd.Lead Sponsor
652 Previous Clinical Trials
100,160 Total Patients Enrolled
Wei Shi, MD,PhDStudy DirectorJiangsu Hengrui Pharmaceuticals Co.,Ltd
3 Previous Clinical Trials
733 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking or are expected to take certain medications that can interact with the study treatment and may cause side effects.You have cancer that has spread to your brain and is currently active.You have already received treatment with targeted drugs for HER2 gene mutations or with a medication called docetaxel.
Research Study Groups:
This trial has the following groups:- Group 1: Study treatment Arm
- Group 2: Control Arm
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.