Carcinoma, Non-Small-Cell LungPhase 3NCT00034268
A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer
A Phase 3 study testing LY900003 in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 105 sites in 21 countries.
Trial summary
The purposes of this study are to determine: 1. If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- LY900003
- How many people
- Not given
- Where
- 105 sitesin 21 countries
- Study dates
- Mar 2002to not given
- Phase
- Phase 3
- 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
- Stage IIIB or IV non-small lung cancer
- Able to visit the doctor's office
- At least 18 years of age
- Adequate kidney, adrenal, and liver function
Who cannot join
- Prior chemotherapy or biologic therapy for NSCLC
- Central nervous system tumors
- Pregnant or breastfeeding
Trial locations and contacts
105 sites in 21 countries.
105 sites in 21 countries
United States20 sites
Study site
Abingdon, Virginia
Study site
Arlington, Texas
Study site
Baltimore, Maryland
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Fort Collins, Colorado
Study site
Hot Springs, Arkansas
Study site
Indianapolis, Indiana
Study site
Latham, New York
Study site
Los Angeles, California
Study site
Marshfield, Wisconsin
Study site
Minneapolis, Minnesota
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Robbinsdale, Minnesota
Study site
Santa Rosa, California
Study site
Springdale, Arkansas
Study site
Tucker, Georgia
Study site
Wilmington, Delaware
Germany14 sites
Study site
Augsburg
Study site
Berlin
Study site
Frankfurt am Main, Hesse
Study site
Freiburg im Breisgau
Study site
Grobhansdorf
Study site
Hamburg
Study site
Heidelberg
Study site
Hofheim
Study site
Koin
Study site
Leipzig
Study site
München
Study site
Neustadt/Suedharz
Study site
Trier
Study site
Ulm
Spain10 sites
Study site
Alicante, Alicante
Study site
Badalona, Barcelona
Study site
Barakaldo, Vizcaya
Study site
Barcelona, Barcelona
Study site
Madrid, Madrid
Study site
Oviedo, Principality of Asturias
Study site
Palma de Mallorca, Palma de Mallorca
Study site
Sabadell, Barcelona
Study site
Valencia, Valenica
Study site
Zaragoza, Zaragoza
France8 sites
Study site
Brest
Study site
Nice
Study site
Paris
Study site
Pessac
Study site
Rouen
Study site
Saint-Herblain
Study site
Tours
Study site
Vandœuvre-lès-Nancy
United Kingdom7 sites
Study site
Cardiff, South Glamorgan
Study site
Glasgow, Scotland
Study site
Hull, East Yorkshire
Study site
London, Greater London
Study site
Newcastle upon Tyne, Tyneside
Study site
Nottingham, Nottinghamshire
Study site
Southampton, Hampshire
Netherlands6 sites
Study site
's-Hertogenbosch
Study site
Amsterdam
Study site
Arnhem
Study site
Groningen
Study site
Nieuwegien
Study site
Zwolle
Belgium5 sites
Study site
Brasschaat
Study site
Edegem
Study site
Liège
Study site
Merksem
Study site
Ostend
India5 sites
Study site
Bangalore, Karnataka
Study site
Ludhiana, Punjab
Study site
Mumbai, Maharashtra
Study site
New Dehli
Study site
Pune, Maharashtra
Italy5 sites
Study site
Perugia
Study site
Pisa
Study site
Ravenna
Study site
Roma
Study site
Rozzano, Milano
South Africa5 sites
Study site
Arcadia, Gauteng
Study site
Durban
Study site
Overport, Durban
Study site
Parklands
Study site
Tygerberg
Poland4 sites
Study site
Krakow-Nowa Huta
Study site
Otwock, Masovian Voivodeship
Study site
Warsaw, Warszawa
Study site
Wroclaw
Taiwan3 sites
Study site
Taichung, Taiwan, Province of China
Study site
Taipei
Study site
Taoyuan, Kuei-Shan
Argentina2 sites
Study site
Ciudad de Buenos Aires
Study site
Mendoza, Mendoza Province
About this study
The purposes of this study are to determine:
- If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone.
- The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be associated with the combination of these three drugs.
- Whether LY900003 plus gemcitabine and cisplatin can make your tumor smaller or disappear, and for how long, compared with gemcitabine and cisplatin alone.
Read more
It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate LY900003 plus gemcitabine and cisplatin for other possible uses or for other medical or scientific purposes other than those currently proposed.
LY900003 may not add any benefit to gemcitabine plus cisplatin.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- LY900003
- Keywords
- non-small cell lung cancer, Stage IIIB or IV non-small cell lung cancer (NSCLC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY900003Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2002 (estimated)
- Study startMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034268
- Sponsor's protocol ID
- 6428
- Other IDs
- H7X-MC-JVAA
- Status last verified
- Jul 2006
- First submitted
- 24 Apr 2002
- Last updated
- 19 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00034268
- Acronym / sponsor ID
- 6428
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- non-small cell lung cancer, Stage IIIB or IV non-small cell lung cancer (NSCLC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- First posted
- 25 Apr 2002 (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.
The purposes of this study are to determine:
- If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone.
- The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be associated with the combination of these three drugs.
- Whether LY900003 plus gemcitabine and cisplatin can make your tumor smaller or disappear, and for how long, compared with gemcitabine and cisplatin alone.
It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate LY900003 plus gemcitabine and cisplatin for other possible uses or for other medical or scientific purposes other than those currently proposed.
LY900003 may not add any benefit to gemcitabine plus cisplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage IIIB or IV non-small lung cancer
- Able to visit the doctor's office
- At least 18 years of age
- Adequate kidney, adrenal, and liver function
Key exclusion criteria (3 listed)
- Prior chemotherapy or biologic therapy for NSCLC
- Central nervous system tumors
- Pregnant or breastfeeding
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 |
|---|---|---|
| LY900003 | Drug | – |
Primary outcome
Not reported in the source record.
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 19 Jul 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
105 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY900003 in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 105 sites in 21 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 4 inclusion and 3 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 19 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 105 sites in United States, Germany, Spain, France, United Kingdom and 16 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 19 Jul 2006.