Non-Small-Cell Lung CancerPhase 2NCT00063388
Phase II Study in Patients With Recurrent Non-Small-Cell Lung Cancer
A Phase 2 study testing Cetuximab in people with Non-Small-Cell Lung Cancer, run by Eli Lilly and Company at 8 sites in United States.
Trial summary
Determine tumor response rate and time to disease progression, survival and safety in total populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2003to Jun 2005
- 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
- Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
- Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
- Unidimensionally measurable NSCLC
- Subjects with tumor tissue available for EGFR assessment
- ECOG performance status of 0 or 1
- Subjects with asymptomatic brain metastasis were eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have been off steroids
Who cannot join
- Women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Male subjects must also have agreed to use effective contraception
- Women of childbearing potential using a prohibited contraceptive method
- Women who were pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
ImClone Investigational Site
Aventura, Florida, 33180
ImClone Investigational Site
Boston, Massachusetts, 02114
ImClone Investigational Site
Boston, Massachusetts, 02115
ImClone Investigational Site
Chicago, Illinois, 60612
ImClone Investigational Site
Indianapolis, Indiana, 46202
ImClone Investigational Site
Miami Beach, Florida, 33140
ImClone Investigational Site
South Bend, Indiana, 46601
ImClone Investigational Site
St Louis, Missouri, 63110
About this study
Official title: A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)
Determine tumor response rate and time to disease progression, survival and safety in total populations.
Read the detailed description
To determine the tumor response rate and time to disease progression, survival and safety in the EGFR-positive, EGFR-negative and total populations.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Cetuximab
- Keywords
- Non, Small, Cell, Lung, Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Cerebral Palsy, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabBiological
Also called Erbitux
Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes). Receives: Biological: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects.
Measured: Every 8 weeks
Secondary outcomes (4)
Determine the tumor response rate in the total population and in EGFR- subjects
Measured: Every 8 weeks
Time to disease progression in the EGFR+ and total populations.
Measured: Every 8 weeks
Survival in the EGFR+ and total populations.
Measured: Every 8 weeks
Safety in the EGFR+ and total populations.
Measured: Every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2003 (estimated)
- Study startMay 2003
- Primary completionJun 2005
- Study completionJun 2005
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 CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- E-mail: ClinicalTrials@ ImClone.com, Study chair, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063388
- Sponsor's protocol ID
- CA225-012
- Status last verified
- Apr 2010
- First submitted
- 25 Jun 2003
- Last updated
- 12 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00063388
- Acronym / sponsor ID
- CA225-012
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- Non, Small, Cell, Lung, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 27 Jun 2003 (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.
Determine tumor response rate and time to disease progression, survival and safety in total populations.
Detailed description
To determine the tumor response rate and time to disease progression, survival and safety in the EGFR-positive, EGFR-negative and total populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CetuximabCetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
- Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
- Unidimensionally measurable NSCLC
- Subjects with tumor tissue available for EGFR assessment
- ECOG performance status of 0 or 1
Key exclusion criteria (4 listed)
- Women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Male subjects must also have agreed to use effective contraception
- Women of childbearing potential using a prohibited contraceptive method
- Women who were pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
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 |
|---|---|---|
| CetuximabAlso: ErbituxCetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes). | Biological | 1 |
Primary outcome
The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects.
Time frame: Every 8 weeks
4 secondary outcomes
Determine the tumor response rate in the total population and in EGFR- subjects
Time frame: Every 8 weeks
Time to disease progression in the EGFR+ and total populations.
Time frame: Every 8 weeks
Survival in the EGFR+ and total populations.
Time frame: Every 8 weeks
Safety in the EGFR+ and total populations.
Time frame: Every 8 weeks
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 12 Apr 2010.
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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.
E-mail: ClinicalTrials@ ImClone.com study chair
Eli Lilly and Company
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab in people with Non-Small-Cell Lung Cancer, run by Eli Lilly and Company at 8 sites 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 6 inclusion and 4 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 12 Apr 2010. 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 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.
What does the primary outcome measure?
The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects. (time frame: Every 8 weeks). 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 12 Apr 2010.