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CompletedNCT00328588Updated Jan 2, 2008

LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy

A Phase 2 interventional study of YM155 in Lung Cancer, Cancer of Lung and Cancer of the Lung, sponsored by Astellas Pharma Inc. Completed at 8 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-02.

Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.

02

Conditions studied

  • Lung Cancer
  • Cancer of Lung
  • Cancer of the Lung
  • Non-Small Cell Lung Carcinoma
  • Carcinoma, Non-Small Cell Lung

Keywords

  • Treatment Efficacy
  • Treatment Effectiveness
  • Disease Management
  • Treatment
  • Safety
03

In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's enrollment of 37 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histologically or cytologically confirmed non-small cell lung cancer.
  • Prior chemotherapy regimen(s) for lung cancer

Exclusion criteria

Exclusion Criteria:

  • History of other malignancy in the last 5 years
  • Major surgery within the past 21 days
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    1

    7 days continuous infusion

    Drug: YM155

Interventions

06

What researchers measure

Primary outcomes

  1. Tumor response rate (CR+PR)

    Time frame: In first 6 cycles

07

Study locations

8 sites
  • Chomutov, 43012, Czechia
  • Novi Jicin, 74101, Czechia
  • Ostrava, 70852, Czechia
  • Prague, 15006, Czechia
  • Prague, 18081, Czechia
  • Großhansdorf, 22927, Germany
  • Amsterdam, 1081HV, Netherlands
  • Amsterdam, 3075 EA, Netherlands
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2006, a primary completion of Mar 2007 and a completion of Mar 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2006
First posted
May 22, 2006
Start
Dec 2006
Primary completionActual
Mar 2007
CompletionActual
Mar 2007
Last update
Jan 2, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 2, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00328588
Lead sponsor
Astellas Pharma Inc
First posted
May 22, 2006
Start date
Dec 2006
Primary completion
Mar 2007
Completion
Mar 2007
Last update
Jan 2, 2008

Study contacts

Medical Director
study director · Astellas Pharma Europe B.V.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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