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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

PYRAMID-1 Trial Summary

This trial is testing a new drug, pyrotinib, to see if it is more effective and has fewer side effects than the standard treatment, docetaxel, for patients with a specific type of lung cancer that has spread and who have not responded to other treatments.

Eligible Conditions
  • Non-squamous Non-small-cell Lung Cancer
  • HER2 Mutation

PYRAMID-1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
AEs and SAEs
Disease control rate (DCR)
Duration of response (DoR)
+7 more

PYRAMID-1 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
625 Previous Clinical Trials
94,646 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pyrotinib undergone approval by the FDA?

"Pyrotinib received a safety score of 3 from our analysts at Power. This is due to the fact that Pyrotinib is in Phase 3 clinical trials, meaning that there is both some evidence of efficacy and repeated rounds of data supporting its safety."

Answered by AI

Could you please share how many people have signed up to participate in this research project?

"Yes, this is an active recruitment according to the clinicaltrials.gov website. The details of the study were first posted on September 11th, 2020 with the last update being October 18th, 2021. A total of 150 people are needed for the trial which will take place at 11 locations."

Answered by AI

Are there different locations in the United States where this research is taking place?

"11 hospitals are running this experiment as of now. The ones in Sacramento, Saint Petersburg and Houston are the closest to you, so try and pick one of those locations to reduce travel time if you do end up participating."

Answered by AI

What type of cancer is Pyrotinib most effective against?

"Pyrotinib is most frequently used to treat malignant neoplasms, but it can also be effective in treating sarcoma, different types of cancerous growths in the esophagus, and other conditions."

Answered by AI

Are there any more places available for people who want to try this new treatment?

"That is correct, the online clinicaltrials.gov registry shows that this particular trial is still seeking candidates. 150 people are needed in total, and there are 11 different sites where potential participants can go."

Answered by AI

Could you provide some more information on Pyrotinib research?

"As of the current moment, there are 380 Pyrotinib trials that have completed or are still in progress. Out of those, 139 studies are in Phase 3. The vast majority of trials for this treatment occur in Fuzhou, Fujian; however, 23121 locations around the world are running trials for Pyrotinib."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04447118.
~33 spots leftby Apr 2025
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