Carcinoma, Non-Small-Cell LungPhase 2NCT00034606
Comparing 3 Schedules of Alimta Plus Gemzar
A Phase 2 study testing Pemetrexed (Alimta) in combination with gemcitabine (Gemzar) in people with Carcinoma, Non-Small-Cell Lung and Lung Neoplasms, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of the study is to measure tumor response rates for three schedules of Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or metastatic non small cell lung cancer who have received no prior chemotherapy regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
- What is being tested?
- Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- Diagnosis of non-small lung cancer
- No prior chemotherapy
- Able to care for self
Who cannot join
- An ongoing infection
- Pregnancy or breast feeding
- Other serious medical condition
- Cancer that has spread to the brain
- Inability to take folic acid
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to measure tumor response rates for three schedules of Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or metastatic non small cell lung cancer who have received no prior chemotherapy regimen.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
- Being tested
- Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)
- Keywords
- Lung cancer, cancer, neoplasm, non-small, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2002 (estimated)
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 2
- 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
- NCT00034606
- Sponsor's protocol ID
- 5115
- Other IDs
- H3E-MC-JMEL
- Status last verified
- Jul 2006
- First submitted
- 1 May 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
- Comparing 3 Schedules of Alimta Plus Gemzar
- ClinicalTrials.gov ID
- NCT00034606
- Acronym / sponsor ID
- 5115
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
- Keywords
- Lung cancer, cancer, neoplasm, non-small, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- First posted
- 2 May 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 purpose of the study is to measure tumor response rates for three schedules of Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or metastatic non small cell lung cancer who have received no prior chemotherapy regimen.
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 (3 listed)
- Diagnosis of non-small lung cancer
- No prior chemotherapy
- Able to care for self
Key exclusion criteria (5 listed)
- An ongoing infection
- Pregnancy or breast feeding
- Other serious medical condition
- Cancer that has spread to the brain
- Inability to take folic acid
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 |
|---|---|---|
| Pemetrexed (Alimta) in combination with gemcitabine (Gemzar) | 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed (Alimta) in combination with gemcitabine (Gemzar) in people with Carcinoma, Non-Small-Cell Lung and Lung Neoplasms, run by Eli Lilly and Company at 1 site in United States.
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 3 inclusion and 5 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 1 site in United States. 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.
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.