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NCT04447118 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Jiangsu HengRui Medicine Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 151
- Enrollment target
NCT04447118: Completed Phase 3 study, sponsored by Jiangsu HengRui Medicine Co..
NCT04447118 is a Phase 3 study that has completed, run by Jiangsu HengRui Medicine Co.. The registered enrollment target is 151 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04447118, a Phase 3 study, has completed, sponsored by Jiangsu HengRui Medicine Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 151 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Docetaxel
- DRUG Pyrotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2020-09-11 |
| Est. Completion | 2024-12-06 |
| Phase | Phase 3 |
What the finished NCT04447118 record still lists
NCT04447118 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT04447118 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04447118 about?
NCT04447118 is a clinical study titled "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". 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.
What is the current status of trial NCT04447118?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 151 participants. The study started on 2020-09-11. Estimated completion is 2024-12-06.
What interventions are being tested in trial NCT04447118?
The interventions under investigation include: Docetaxel (DRUG), Pyrotinib (DRUG).
Who is sponsoring clinical trial NCT04447118?
This trial is sponsored by Jiangsu HengRui Medicine Co., which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04447118's enrollment target sits among peer trials
151 1517th of 2000 higher than 482 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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