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NCT01454934 · ClinicalTrials.gov registry record · Phase 3

A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer

A Phase 3 study, sponsored by Eisai.

Completed
Registry status
Phase 3
Development phase
540
Enrollment target

NCT01454934: Completed Phase 3 study, sponsored by Eisai.

NCT01454934 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 540 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01454934, a Phase 3 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 3
Development phase
540 participants
Enrollment target

Study Summary

This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

Primary Outcome

The OS was defined as the time in months from the date of randomization to the date of death, regardless of cause. In the absence of confirmation of death, the participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. The two treatment arms were compared using the log-rank test, stratified by histology, TPC option, and geographic region; and the treatment difference between eribulin mesylate and TPC was tested a

Interventions

  • DRUG Eribulin
  • DRUG TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed

Trial Details

FieldValue
Enrollment Target 540 participants
Start Date 2011-12-09
Est. Completion 2016-05-02
Phase Phase 3
Eisai

287 total trials

What the finished NCT01454934 record still lists

NCT01454934 is an interventional study that assigns participants to a tested intervention. The registered 540 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 (30% lower).

The record links to 0 conditions, and to 2 interventions - of which Eribulin is the first listed.

NCT01454934 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01454934 about?

NCT01454934 is a clinical study titled "A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer". This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

What is the current status of trial NCT01454934?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2011-12-09. Estimated completion is 2016-05-02.

What interventions are being tested in trial NCT01454934?

The interventions under investigation include: Eribulin (DRUG), TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed (DRUG).

Who is sponsoring clinical trial NCT01454934?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01454934's enrollment target sits among peer trials

540 694th of 2000 higher than 1,301 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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Source: ClinicalTrials.gov NCT01454934, the US trial registry maintained by the National Library of Medicine. NCT01454934 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.