Lung CancerPhase 2NCT00328588
LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy
A Phase 2 study testing YM155 in people with Lung Cancer and Cancer of Lung, run by Astellas Pharma Inc at 8 sites in 3 countries.
Trial summary
A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Cancer of Lung, Cancer of the Lung
- What is being tested?
- YM155
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Dec 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed non-small cell lung cancer.
- Prior chemotherapy regimen(s) for lung cancer
Who cannot join
- History of other malignancy in the last 5 years
- Major surgery within the past 21 days
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Czechia5 sites
Study site
Chomutov, 43012
Study site
Novi Jicin, 74101
Study site
Ostrava, 70852
Study site
Prague, 15006
Study site
Prague, 18081
Netherlands2 sites
Study site
Amsterdam, 1081HV
Study site
Amsterdam, 3075 EA
About this study
A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.
- Conditions
- Lung Cancer, Cancer of Lung, Cancer of the Lung, Non-Small Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung
- Being tested
- YM155
- Keywords
- Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM155Drug
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 7 days continuous infusion Receives: Drug: YM155 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate (CR+PR)
Measured: In first 6 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startDec 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328588
- Sponsor's protocol ID
- 155-CL-006
- Status last verified
- Dec 2007
- First submitted
- 19 May 2006
- Last updated
- 2 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT00328588
- Acronym / sponsor ID
- 155-CL-006
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: YM1557 days continuous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically or cytologically confirmed non-small cell lung cancer.
- Prior chemotherapy regimen(s) for lung cancer
Key exclusion criteria (2 listed)
- History of other malignancy in the last 5 years
- Major surgery within the past 21 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YM155IV | Drug | 1 |
Primary outcome
Tumor response rate (CR+PR)
Time frame: In first 6 cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Europe B.V.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM155 in people with Lung Cancer and Cancer of Lung, run by Astellas Pharma Inc at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Czechia, Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate (CR+PR) (time frame: In first 6 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2008.