Lung Cancer - Non Small CellPhase 2NCT01471197
Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer
A Phase 2 study testing Ipilimumab and Pemetrexed in people with Lung Cancer - Non Small Cell, run by Bristol-Myers Squibb at 13 sites in 5 countries.
Trial summary
The purpose of this trial is to determine whether Ipilimumab will prolong survival when compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer - Non Small Cell
- What is being tested?
- Ipilimumab and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Jul 2012to Feb 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Non-Squamous, Non-Small Cell Lung Cancer
- Recurrent/Stage IV Non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Not progressing after 4 cycles of a platinum-based first line chemotherapy
Who cannot join
- Brain Metastases (unless stable)
- Autoimmune Diseases
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
United States7 sites
Blue Ridge Cancer Care
Christiansburg, Virginia, 24073
Medical And Surgical Specialists, Llc
Galesburg, Illinois, 61401
Marin Specialty Care, Inc.
Greenbrae, California, 94904
Meritus Center For Clinical Research
Hagerstown, Maryland, 21742
Carolina Biooncology Institute
Huntersville, North Carolina, 28078
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353
Quincy Medical Group
Quincy, Illinois, 62301
Belgium2 sites
Local Institution
Bruges, 8310
Local Institution
Sint-Niklaas, 9100
Germany2 sites
Local Institution
Hamburg, 21075
Local Institution
Heidelberg, 69126
About this study
Official title: A Randomized, Open-Label, Phase 2 Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Subjects With Recurrent/Stage IV Non-Squamous, Non-Small Cell Lung Cancer Who Have Not Progressed After Four Cycles of a Platinum-Based First Line Chemotherapy
The purpose of this trial is to determine whether Ipilimumab will prolong survival when compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.
- Conditions
- Lung Cancer - Non Small Cell
- Being tested
- Ipilimumab, Pemetrexed
- 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.
IpilimumabBiological
Also called Yervoy, BMS-734016
Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion
PemetrexedBiological
Also called Alimta
IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Ipilimumab | Experimental | Not described Receives: Biological: Ipilimumab |
| Arm 2: Pemetrexed | Active comparator | Not described Receives: Biological: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival of Participants During the Study - All Treated Participants
Overall survival (OS) was defined as the time from the date of randomization until the date of death. For those participants who did not die by the time the study was terminated and last patient, last visit occurred, OS was censored (+) on the last date the participant was known to be alive. OS is presented below in increasing monthly categories of survival. OS analysis was to be performed when a total of approximately 132 deaths were observed but due to the early termination of the study, statistical analyses were not performed.
Measured: Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started
Secondary outcomes (2)
Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants
Due to study termination, the categories presented below are deaths occurring within 30 days of last dose and deaths occurring within 32 days of last dose. If the study had not been terminated early, the categories presented would have been 30 days and 90 days after last dose.
Measured: Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.
Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Participants were evaluated from Day 1 (first day of treatment with study drug) to the date of the last participant, last visit of the study.
Measured: Day 1 to Date of last patient, last visit, approximately 7 months after study started.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startJul 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung Cancer - Non Small CellStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471197
- Sponsor's protocol ID
- CA184-124 ST
- Other IDs
- 2011-000732-29
- Status last verified
- Apr 2014
- First submitted
- 10 Nov 2011
- Last updated
- 12 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Phase 2 Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Subjects With Recurrent/Stage IV Non-Squamous, Non-Small Cell Lung Cancer Who Have Not Progressed After Four Cycles of a Platinum-Based First Line Chemotherapy
- ClinicalTrials.gov ID
- NCT01471197
- Acronym / sponsor ID
- CA184-124 ST
- Conditions
- Lung Cancer - Non Small Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative reasons
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Nov 2011 (estimated)
- Results
- Posted 12 May 2014
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 this trial is to determine whether Ipilimumab will prolong survival when compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Ipilimumab | Experimental | Biological: Ipilimumab |
| Arm 2: Pemetrexed | Active comparator | Biological: Pemetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-Squamous, Non-Small Cell Lung Cancer
- Recurrent/Stage IV Non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Not progressing after 4 cycles of a platinum-based first line chemotherapy
Key exclusion criteria (2 listed)
- Brain Metastases (unless stable)
- Autoimmune Diseases
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 |
|---|---|---|
| IpilimumabAlso: Yervoy, BMS-734016Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion | Biological | Arm 1: Ipilimumab |
| PemetrexedAlso: AlimtaIV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion. | Biological | Arm 2: Pemetrexed |
Primary outcome
Overall Survival of Participants During the Study - All Treated Participants
Time frame: Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started
Overall survival (OS) was defined as the time from the date of randomization until the date of death. For those participants who did not die by the time the study was terminated and last patient, last visit occurred, OS was censored (+) on the last date the participant was known to be alive. OS is presented below in increasing monthly categories of survival. OS analysis was to be performed when a total of approximately 132 deaths were observed but due to the early termination of the study, statistical analyses were not performed.
2 secondary outcomes
Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants
Time frame: Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.
Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants
Time frame: Day 1 to Date of last patient, last visit, approximately 7 months after study started.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab and Pemetrexed in people with Lung Cancer - Non Small Cell, run by Bristol-Myers Squibb at 13 sites in 5 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 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: stopped early, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Belgium, Germany, France, Spain. 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?
Yes. Results are posted in the registry (first posted 12 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival of Participants During the Study - All Treated Participants (time frame: Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started). 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 May 2014.