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Mitotic Inhibitor

Pyrotinib for Non-Small Cell Lung Cancer (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 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

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 more

Awards & 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
651 Previous Clinical Trials
100,128 Total Patients Enrolled
Wei Shi, MD,PhDStudy DirectorJiangsu Hengrui Pharmaceuticals Co.,Ltd
3 Previous Clinical Trials
733 Total Patients Enrolled

Media Library

Docetaxel (Mitotic Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04447118 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Study treatment Arm, Control Arm
Non-Small Cell Lung Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04447118 — Phase 3
Docetaxel (Mitotic Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04447118 — Phase 3
~29 spots leftby Nov 2025
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