Non-Small-Cell Lung CarcinomaPhase 2NCT00112346
Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing Cetuximab + platinum + gemcitabine and Platinum + Gemcitabine in people with Non-Small-Cell Lung Carcinoma, run by Eli Lilly and Company at 38 sites in 2 countries.
Trial summary
The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- Cetuximab + platinum + gemcitabine and Platinum + Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 38 sitesin 2 countries
- Study dates
- Jan 2005to Dec 2006
- 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
- Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
- Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva).
- Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease.
- Must be able to carry out work of light or sedentary nature (e.g. light house work, office work).
- It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.
Who cannot join
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial).
- Symptomatic or uncontrolled metastases in the central nervous system (CNS).
- Peripheral neuropathy.
- Inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,500/mm^3, a platelet count <100,000/mm^3, or a hemoglobin level < 9g/dL.
- Inadequate liver function.
- Inadequate kidney function.
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United States31 sites
Local Institution
Anchorage, Alaska
Local Institution
Annapolis, Maryland
Local Institution
Armonk, New York
Local Institution
Austell, Georgia
Local Institution
Bakersfield, California
Local Institution
Bismarck, North Dakota
Local Institution
Boynton Beach, Florida
Local Institution
Brooksville, Florida
Local Institution
Charleston, South Carolina
Local Institution
Cincinnati, Ohio
Local Institution
Corona, California
Local Institution
Dallas, Texas
Local Institution
Farmington, New Mexico
Local Institution
Frederick, Maryland
Local Institution
Gastonia, North Carolina
Local Institution
Honolulu, Hawaii
Local Institution
Inverness, Florida
Local Institution
Lakewood, Colorado
Local Institution
Mobile, Alabama
Local Institution
Muncie, Indiana
Local Institution
Oxnard, California
Local Institution
Pembroke Pines, Florida
Local Institution
Plymouth, Massachusetts
Local Institution
Portland, Oregon
Local Institution
Rockville, Maryland
Local Institution
San Diego, California
Local Institution
Skokie, Illinois
Local Institution
Stony Brook, New York
Local Institution
Vancouver, Washington
Local Institution
Whittier, California
Local Institution
Wilmington, North Carolina
Canada7 sites
Local Institution
Edmonton, Alberta
Local Institution
Greenfield Park, Quebec
Local Institution
Hamilton, Ontario
Local Institution
Moncton, New Brunswick
Local Institution
Montreal, Ontario
Local Institution
Toronto, Ontario
Local Institution
Windsor, Ontario
About this study
Official title: A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- Cetuximab + platinum + gemcitabine, Platinum + Gemcitabine
- Keywords
- Non-Small Lung Cancer
- 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.
Cetuximab + platinum + gemcitabineDrug
Also called Erbitux
Solution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 \& Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance.
Platinum + GemcitabineDrug
Solution, IV, Gemcitabine given at 1250mg/m2 (Day 1 \& Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Cetuximab + platinum + gemcitabine |
| B | Active comparator | Not described Receives: Drug: Platinum + Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response per treatment arm
Secondary outcomes (1)
disease control, symptom response, symptomatic progression, & progression free survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CarcinomaStudies 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)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112346
- Sponsor's protocol ID
- CA225-100
- Status last verified
- Oct 2015
- First submitted
- 1 Jun 2005
- Last updated
- 28 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00112346
- Acronym / sponsor ID
- CA225-100
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- Non-Small Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 2 Jun 2005 (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 primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Cetuximab + platinum + gemcitabine |
| B | Active comparator | Drug: Platinum + Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
- Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva).
- Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease.
- Must be able to carry out work of light or sedentary nature (e.g. light house work, office work).
- It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.
Key exclusion criteria (8 listed)
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial).
- Symptomatic or uncontrolled metastases in the central nervous system (CNS).
- Peripheral neuropathy.
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 |
|---|---|---|
| Cetuximab + platinum + gemcitabineAlso: ErbituxSolution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 \& Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance. | Drug | A |
| Platinum + GemcitabineSolution, IV, Gemcitabine given at 1250mg/m2 (Day 1 \& Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks. | Drug | B |
Primary outcome
tumor response per treatment arm
1 secondary outcome
disease control, symptom response, symptomatic progression, & progression free survival.
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 28 Oct 2015.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
38 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab + platinum + gemcitabine and Platinum + Gemcitabine in people with Non-Small-Cell Lung Carcinoma, run by Eli Lilly and Company at 38 sites in 2 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 5 inclusion and 8 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 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Canada. 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 per treatment arm. 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 28 Oct 2015.